Teva Pharmaceutical Industries
FDA Approved Drugs

Teva Pharmaceutical Industries

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

Discontinued RX Unclassified OTC
  • Total Records 831
  • Latest Approval Date Jul 28, 2026
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
831
View
Unclassified
80
View
Discontinued
412
View
OTC
1
View
RX
338
View
Company Overview

Company

Teva Pharmaceutical Industries

Country

Israel

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Company Snapshot

Teva Pharmaceutical Industries

5 Basel St., Petach Tikva Israel, 49131

Israel

www.tevapharm.com/ View on Map
FDA Approved Drug Records ( 831 records )
2016
29 Sep
Discontinued Application: 79246

Drug Name

ABACAVIR SULFATE AND LAMIVUDINE

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE;300MG

Approval Date

2016-09-29

79246 / 1

Active Ingredient

ABACAVIR SULFATE; LAMIVUDINE

Application Number

79246

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE;300MG

Approval Date

2016-09-29

Regulatory Status

Discontinued

2018
31 Oct
Discontinued Application: 208432

Drug Name

ABIRATERONE ACETATE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2018-10-31

208432 / 1

Active Ingredient

ABIRATERONE ACETATE

Application Number

208432

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2018-10-31

Regulatory Status

Discontinued

2023
26 Jan
Discontinued Application: 210726

Drug Name

ABIRATERONE ACETATE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2023-01-26

210726 / 1

Active Ingredient

ABIRATERONE ACETATE

Application Number

210726

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2023-01-26

Regulatory Status

Discontinued

2022
24 Jun
Discontinued Application: 212206

Drug Name

ABIRATERONE ACETATE

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2022-06-24

212206 / 1

Active Ingredient

ABIRATERONE ACETATE

Application Number

212206

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2022-06-24

Regulatory Status

Discontinued

2013
04 Apr
RX Application: 202897

Drug Name

ACITRETIN

Product Number

1

Dosage Form

-

Strength

17.5MG

Approval Date

2013-04-04

202897 / 1

Active Ingredient

ACITRETIN

Application Number

202897

Product Number

1

Dosage Form

-

Strength

17.5MG

Approval Date

2013-04-04

Regulatory Status

RX

2013
04 Apr
RX Application: 202897

Drug Name

ACITRETIN

Product Number

2

Dosage Form

-

Strength

22.5MG

Approval Date

2013-04-04

202897 / 2

Active Ingredient

ACITRETIN

Application Number

202897

Product Number

2

Dosage Form

-

Strength

22.5MG

Approval Date

2013-04-04

Regulatory Status

RX

1987
31 Dec
Discontinued Application: 19594

Drug Name

ACTIGALL

Product Number

1

Dosage Form

-

Strength

150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-12-31

19594 / 1

Active Ingredient

URSODIOL

Application Number

19594

Product Number

1

Dosage Form

-

Strength

150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-12-31

Regulatory Status

Discontinued

1987
31 Dec
RX Application: 19594

Drug Name

ACTIGALL

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1987-12-31

19594 / 2

Active Ingredient

URSODIOL

Application Number

19594

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1987-12-31

Regulatory Status

RX

1997
26 Nov
Discontinued Application: 74914

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-11-26

74914 / 1

Active Ingredient

ACYCLOVIR

Application Number

74914

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-11-26

Regulatory Status

Discontinued

1998
18 Mar
Discontinued Application: 75021

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1998-03-18

75021 / 1

Active Ingredient

ACYCLOVIR

Application Number

75021

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1998-03-18

Regulatory Status

Discontinued

1998
18 Mar
Discontinued Application: 75021

Drug Name

ACYCLOVIR

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

1998-03-18

75021 / 2

Active Ingredient

ACYCLOVIR

Application Number

75021

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

1998-03-18

Regulatory Status

Discontinued

1996
13 Feb
Discontinued Application: 11522

Drug Name

ADDERALL 10

Product Number

7

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-02-13

11522 / 7

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

11522

Product Number

7

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-02-13

Regulatory Status

Discontinued

2000
31 Aug
Discontinued Application: 11522

Drug Name

ADDERALL 12.5

Product Number

12

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-08-31

11522 / 12

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

11522

Product Number

12

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-08-31

Regulatory Status

Discontinued

2000
31 Aug
Discontinued Application: 11522

Drug Name

ADDERALL 15

Product Number

13

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-08-31

11522 / 13

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

11522

Product Number

13

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-08-31

Regulatory Status

Discontinued

1996
13 Feb
Discontinued Application: 11522

Drug Name

ADDERALL 20

Product Number

8

Dosage Form

-

Strength

5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-02-13

11522 / 8

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

11522

Product Number

8

Dosage Form

-

Strength

5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-02-13

Regulatory Status

Discontinued

1997
12 May
Discontinued Application: 11522

Drug Name

ADDERALL 30

Product Number

10

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-05-12

11522 / 10

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

11522

Product Number

10

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-05-12

Regulatory Status

Discontinued

1997
12 May
Discontinued Application: 11522

Drug Name

ADDERALL 5

Product Number

9

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-05-12

11522 / 9

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

11522

Product Number

9

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-05-12

Regulatory Status

Discontinued

2000
31 Aug
Discontinued Application: 11522

Drug Name

ADDERALL 7.5

Product Number

11

Dosage Form

-

Strength

1.875MG;1.875MG;1.875MG;1.875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-08-31

11522 / 11

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

11522

Product Number

11

Dosage Form

-

Strength

1.875MG;1.875MG;1.875MG;1.875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-08-31

Regulatory Status

Discontinued

2004
16 Jun
Discontinued Application: 76564

Drug Name

ADENOSINE

Product Number

1

Dosage Form

-

Strength

3MG/ML

Approval Date

2004-06-16

76564 / 1

Active Ingredient

ADENOSINE

Application Number

76564

Product Number

1

Dosage Form

-

Strength

3MG/ML

Approval Date

2004-06-16

Regulatory Status

Discontinued

2008
31 Jul
Discontinued Application: 78676

Drug Name

ADENOSINE

Product Number

1

Dosage Form

-

Strength

3MG/ML

Approval Date

2008-07-31

78676 / 1

Active Ingredient

ADENOSINE

Application Number

78676

Product Number

1

Dosage Form

-

Strength

3MG/ML

Approval Date

2008-07-31

Regulatory Status

Discontinued

2019
12 Jul
Discontinued Application: 208799

Drug Name

AIRDUO DIGIHALER

Product Number

4

Dosage Form

-

Strength

0.055MG/INH;EQ 0.014MG BASE/INH

Approval Date

2019-07-12

208799 / 4

Active Ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Application Number

208799

Product Number

4

Dosage Form

-

Strength

0.055MG/INH;EQ 0.014MG BASE/INH

Approval Date

2019-07-12

Regulatory Status

Discontinued

2019
12 Jul
Discontinued Application: 208799

Drug Name

AIRDUO DIGIHALER

Product Number

5

Dosage Form

-

Strength

0.113MG/INH;EQ 0.014MG BASE/INH

Approval Date

2019-07-12

208799 / 5

Active Ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Application Number

208799

Product Number

5

Dosage Form

-

Strength

0.113MG/INH;EQ 0.014MG BASE/INH

Approval Date

2019-07-12

Regulatory Status

Discontinued

2019
12 Jul
Discontinued Application: 208799

Drug Name

AIRDUO DIGIHALER

Product Number

6

Dosage Form

-

Strength

0.232MG/INH;EQ 0.014MG BASE/INH

Approval Date

2019-07-12

208799 / 6

Active Ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Application Number

208799

Product Number

6

Dosage Form

-

Strength

0.232MG/INH;EQ 0.014MG BASE/INH

Approval Date

2019-07-12

Regulatory Status

Discontinued

2017
27 Jan
RX Application: 208799

Drug Name

AIRDUO RESPICLICK

Product Number

1

Dosage Form

-

Strength

0.055MG/INH;EQ 0.014MG BASE/INH

Approval Date

2017-01-27

208799 / 1

Active Ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Application Number

208799

Product Number

1

Dosage Form

-

Strength

0.055MG/INH;EQ 0.014MG BASE/INH

Approval Date

2017-01-27

Regulatory Status

RX

2017
27 Jan
RX Application: 208799

Drug Name

AIRDUO RESPICLICK

Product Number

2

Dosage Form

-

Strength

0.113MG/INH;EQ 0.014MG BASE/INH

Approval Date

2017-01-27

208799 / 2

Active Ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Application Number

208799

Product Number

2

Dosage Form

-

Strength

0.113MG/INH;EQ 0.014MG BASE/INH

Approval Date

2017-01-27

Regulatory Status

RX

2017
27 Jan
RX Application: 208799

Drug Name

AIRDUO RESPICLICK

Product Number

3

Dosage Form

-

Strength

0.232MG/INH;EQ 0.014MG BASE/INH

Approval Date

2017-01-27

208799 / 3

Active Ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Application Number

208799

Product Number

3

Dosage Form

-

Strength

0.232MG/INH;EQ 0.014MG BASE/INH

Approval Date

2017-01-27

Regulatory Status

RX

-
Unclassified Application: 761089

Drug Name

AJOVY

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

-

761089 / 1

Active Ingredient

FREMANEZUMAB-VFRM

Application Number

761089

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

-

Regulatory Status

Unclassified

1999
09 Nov
Discontinued Application: 75343

Drug Name

ALBUTEROL SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 0.083% BASE

Approval Date

1999-11-09

75343 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

75343

Product Number

1

Dosage Form

-

Strength

EQ 0.083% BASE

Approval Date

1999-11-09

Regulatory Status

Discontinued

2007
31 Dec
Discontinued Application: 76724

Drug Name

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.083% BASE;0.017%

Approval Date

2007-12-31

76724 / 1

Active Ingredient

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Application Number

76724

Product Number

1

Dosage Form

-

Strength

EQ 0.083% BASE;0.017%

Approval Date

2007-12-31

Regulatory Status

Discontinued

2008
06 Feb
Discontinued Application: 76184

Drug Name

ALENDRONATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 70MG BASE

Approval Date

2008-02-06

76184 / 1

Active Ingredient

ALENDRONATE SODIUM

Application Number

76184

Product Number

1

Dosage Form

-

Strength

EQ 70MG BASE

Approval Date

2008-02-06

Regulatory Status

Discontinued

2008
04 Aug
Discontinued Application: 76184

Drug Name

ALENDRONATE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 35MG BASE

Approval Date

2008-08-04

76184 / 2

Active Ingredient

ALENDRONATE SODIUM

Application Number

76184

Product Number

2

Dosage Form

-

Strength

EQ 35MG BASE

Approval Date

2008-08-04

Regulatory Status

Discontinued

2015
07 Jul
RX Application: 78027

Drug Name

ALMOTRIPTAN MALATE

Product Number

1

Dosage Form

-

Strength

EQ 6.25MG BASE

Approval Date

2015-07-07

78027 / 1

Active Ingredient

ALMOTRIPTAN MALATE

Application Number

78027

Product Number

1

Dosage Form

-

Strength

EQ 6.25MG BASE

Approval Date

2015-07-07

Regulatory Status

RX

2015
07 Jul
RX Application: 78027

Drug Name

ALMOTRIPTAN MALATE

Product Number

2

Dosage Form

-

Strength

EQ 12.5MG BASE

Approval Date

2015-07-07

78027 / 2

Active Ingredient

ALMOTRIPTAN MALATE

Application Number

78027

Product Number

2

Dosage Form

-

Strength

EQ 12.5MG BASE

Approval Date

2015-07-07

Regulatory Status

RX

2019
05 Feb
RX Application: 209942

Drug Name

ALYQ

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2019-02-05

209942 / 1

Active Ingredient

TADALAFIL

Application Number

209942

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2019-02-05

Regulatory Status

RX

1991
23 Aug
Discontinued Application: 73115

Drug Name

AMANTADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/5ML

Approval Date

1991-08-23

73115 / 1

Active Ingredient

AMANTADINE HYDROCHLORIDE

Application Number

73115

Product Number

1

Dosage Form

-

Strength

50MG/5ML

Approval Date

1991-08-23

Regulatory Status

Discontinued

1998
30 Nov
RX Application: 74739

Drug Name

AMIODARONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1998-11-30

74739 / 1

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

74739

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1998-11-30

Regulatory Status

RX

2016
26 Oct
Discontinued Application: 91154

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;20MG

Approval Date

2016-10-26

91154 / 1

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

91154

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;20MG

Approval Date

2016-10-26

Regulatory Status

Discontinued

2016
26 Oct
Discontinued Application: 91154

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;40MG

Approval Date

2016-10-26

91154 / 2

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

91154

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;40MG

Approval Date

2016-10-26

Regulatory Status

Discontinued

2016
26 Oct
Discontinued Application: 91154

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;20MG

Approval Date

2016-10-26

91154 / 3

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

91154

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;20MG

Approval Date

2016-10-26

Regulatory Status

Discontinued

2016
26 Oct
Discontinued Application: 91154

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;40MG

Approval Date

2016-10-26

91154 / 4

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

91154

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;40MG

Approval Date

2016-10-26

Regulatory Status

Discontinued

2007
18 May
Discontinued Application: 77179

Drug Name

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE;10MG

Approval Date

2007-05-18

77179 / 1

Active Ingredient

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Application Number

77179

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE;10MG

Approval Date

2007-05-18

Regulatory Status

Discontinued

2007
18 May
Discontinued Application: 77179

Drug Name

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;10MG

Approval Date

2007-05-18

77179 / 2

Active Ingredient

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Application Number

77179

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;10MG

Approval Date

2007-05-18

Regulatory Status

Discontinued

2007
18 May
Discontinued Application: 77179

Drug Name

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;20MG

Approval Date

2007-05-18

77179 / 3

Active Ingredient

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Application Number

77179

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;20MG

Approval Date

2007-05-18

Regulatory Status

Discontinued

2007
18 May
Discontinued Application: 77179

Drug Name

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;20MG

Approval Date

2007-05-18

77179 / 4

Active Ingredient

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Application Number

77179

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;20MG

Approval Date

2007-05-18

Regulatory Status

Discontinued

2011
05 Jul
Discontinued Application: 77179

Drug Name

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 5MG BASE;40MG

Approval Date

2011-07-05

77179 / 5

Active Ingredient

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Application Number

77179

Product Number

5

Dosage Form

-

Strength

EQ 5MG BASE;40MG

Approval Date

2011-07-05

Regulatory Status

Discontinued

2011
05 Jul
Discontinued Application: 77179

Drug Name

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

EQ 10MG BASE;40MG

Approval Date

2011-07-05

77179 / 6

Active Ingredient

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Application Number

77179

Product Number

6

Dosage Form

-

Strength

EQ 10MG BASE;40MG

Approval Date

2011-07-05

Regulatory Status

Discontinued

2015
30 Mar
Discontinued Application: 91235

Drug Name

AMLODIPINE BESYLATE AND VALSARTAN

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;160MG

Approval Date

2015-03-30

91235 / 1

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

91235

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;160MG

Approval Date

2015-03-30

Regulatory Status

Discontinued

2015
30 Mar
Discontinued Application: 91235

Drug Name

AMLODIPINE BESYLATE AND VALSARTAN

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE;160MG

Approval Date

2015-03-30

91235 / 2

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

91235

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE;160MG

Approval Date

2015-03-30

Regulatory Status

Discontinued

2015
30 Mar
Discontinued Application: 91235

Drug Name

AMLODIPINE BESYLATE AND VALSARTAN

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;320MG

Approval Date

2015-03-30

91235 / 3

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

91235

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;320MG

Approval Date

2015-03-30

Regulatory Status

Discontinued

2015
30 Mar
Discontinued Application: 91235

Drug Name

AMLODIPINE BESYLATE AND VALSARTAN

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;320MG

Approval Date

2015-03-30

91235 / 4

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

91235

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;320MG

Approval Date

2015-03-30

Regulatory Status

Discontinued

2012
25 Sep
Discontinued Application: 200435

Drug Name

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;12.5MG;160MG

Approval Date

2012-09-25

200435 / 1

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

200435

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;12.5MG;160MG

Approval Date

2012-09-25

Regulatory Status

Discontinued

2012
25 Sep
Discontinued Application: 200435

Drug Name

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;25MG;160MG

Approval Date

2012-09-25

200435 / 2

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

200435

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;25MG;160MG

Approval Date

2012-09-25

Regulatory Status

Discontinued

2012
25 Sep
Discontinued Application: 200435

Drug Name

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;25MG;160MG

Approval Date

2012-09-25

200435 / 3

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

200435

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;25MG;160MG

Approval Date

2012-09-25

Regulatory Status

Discontinued

2012
25 Sep
Discontinued Application: 200435

Drug Name

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;25MG;320MG

Approval Date

2012-09-25

200435 / 4

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

200435

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;25MG;320MG

Approval Date

2012-09-25

Regulatory Status

Discontinued

2012
25 Sep
Discontinued Application: 200435

Drug Name

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

5

Dosage Form

-

Strength

EQ 10MG BASE;12.5MG;160MG

Approval Date

2012-09-25

200435 / 5

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

200435

Product Number

5

Dosage Form

-

Strength

EQ 10MG BASE;12.5MG;160MG

Approval Date

2012-09-25

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 61926

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

61926 / 1

Active Ingredient

AMOXICILLIN

Application Number

61926

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 61926

Drug Name

AMOXICILLIN

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

61926 / 3

Active Ingredient

AMOXICILLIN

Application Number

61926

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 61931

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

1982-01-01

61931 / 1

Active Ingredient

AMOXICILLIN

Application Number

61931

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 61931

Drug Name

AMOXICILLIN

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

1982-01-01

61931 / 2

Active Ingredient

AMOXICILLIN

Application Number

61931

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

1982-01-01

Regulatory Status

RX

1992
22 Dec
RX Application: 64013

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1992-12-22

64013 / 1

Active Ingredient

AMOXICILLIN

Application Number

64013

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1992-12-22

Regulatory Status

RX

1995
11 Sep
RX Application: 64013

Drug Name

AMOXICILLIN

Product Number

2

Dosage Form

-

Strength

125MG

Approval Date

1995-09-11

64013 / 2

Active Ingredient

AMOXICILLIN

Application Number

64013

Product Number

2

Dosage Form

-

Strength

125MG

Approval Date

1995-09-11

Regulatory Status

RX

2000
18 Sep
RX Application: 65056

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2000-09-18

65056 / 1

Active Ingredient

AMOXICILLIN

Application Number

65056

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2000-09-18

Regulatory Status

RX

2000
18 Sep
RX Application: 65056

Drug Name

AMOXICILLIN

Product Number

2

Dosage Form

-

Strength

875MG

Approval Date

2000-09-18

65056 / 2

Active Ingredient

AMOXICILLIN

Application Number

65056

Product Number

2

Dosage Form

-

Strength

875MG

Approval Date

2000-09-18

Regulatory Status

RX

2002
04 Dec
RX Application: 65119

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

200MG/5ML

Approval Date

2002-12-04

65119 / 1

Active Ingredient

AMOXICILLIN

Application Number

65119

Product Number

1

Dosage Form

-

Strength

200MG/5ML

Approval Date

2002-12-04

Regulatory Status

RX

2002
04 Dec
RX Application: 65119

Drug Name

AMOXICILLIN

Product Number

2

Dosage Form

-

Strength

400MG/5ML

Approval Date

2002-12-04

65119 / 2

Active Ingredient

AMOXICILLIN

Application Number

65119

Product Number

2

Dosage Form

-

Strength

400MG/5ML

Approval Date

2002-12-04

Regulatory Status

RX

2004
25 May
RX Application: 65089

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

1

Dosage Form

-

Strength

200MG/5ML;EQ 28.5MG BASE/5ML

Approval Date

2004-05-25

65089 / 1

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65089

Product Number

1

Dosage Form

-

Strength

200MG/5ML;EQ 28.5MG BASE/5ML

Approval Date

2004-05-25

Regulatory Status

RX

2004
25 May
RX Application: 65089

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

2

Dosage Form

-

Strength

400MG/5ML;EQ 57MG BASE/5ML

Approval Date

2004-05-25

65089 / 2

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65089

Product Number

2

Dosage Form

-

Strength

400MG/5ML;EQ 57MG BASE/5ML

Approval Date

2004-05-25

Regulatory Status

RX

2002
29 Oct
RX Application: 65096

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

1

Dosage Form

-

Strength

875MG;EQ 125MG BASE

Approval Date

2002-10-29

65096 / 1

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65096

Product Number

1

Dosage Form

-

Strength

875MG;EQ 125MG BASE

Approval Date

2002-10-29

Regulatory Status

RX

2002
30 Oct
RX Application: 65101

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

1

Dosage Form

-

Strength

500MG;EQ 125MG BASE

Approval Date

2002-10-30

65101 / 1

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65101

Product Number

1

Dosage Form

-

Strength

500MG;EQ 125MG BASE

Approval Date

2002-10-30

Regulatory Status

RX

2004
12 Mar
RX Application: 65162

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

1

Dosage Form

-

Strength

600MG/5ML;EQ 42.9MG BASE/5ML

Approval Date

2004-03-12

65162 / 1

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65162

Product Number

1

Dosage Form

-

Strength

600MG/5ML;EQ 42.9MG BASE/5ML

Approval Date

2004-03-12

Regulatory Status

RX

2005
09 Feb
RX Application: 65205

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

1

Dosage Form

-

Strength

200MG;EQ 28.5MG BASE

Approval Date

2005-02-09

65205 / 1

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65205

Product Number

1

Dosage Form

-

Strength

200MG;EQ 28.5MG BASE

Approval Date

2005-02-09

Regulatory Status

RX

2005
09 Feb
RX Application: 65205

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

2

Dosage Form

-

Strength

400MG;EQ 57MG BASE

Approval Date

2005-02-09

65205 / 2

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65205

Product Number

2

Dosage Form

-

Strength

400MG;EQ 57MG BASE

Approval Date

2005-02-09

Regulatory Status

RX

1982
01 Dec
RX Application: 61931

Drug Name

AMOXICILLIN PEDIATRIC

Product Number

3

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-12-01

61931 / 3

Active Ingredient

AMOXICILLIN

Application Number

61931

Product Number

3

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-12-01

Regulatory Status

RX

2010
28 Jun
RX Application: 78058

Drug Name

ANASTROZOLE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2010-06-28

78058 / 1

Active Ingredient

ANASTROZOLE

Application Number

78058

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2010-06-28

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 7883

Drug Name

ANTABUSE

Product Number

2

Dosage Form

-

Strength

500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

7883 / 2

Active Ingredient

DISULFIRAM

Application Number

7883

Product Number

2

Dosage Form

-

Strength

500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 7883

Drug Name

ANTABUSE

Product Number

3

Dosage Form

-

Strength

250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

7883 / 3

Active Ingredient

DISULFIRAM

Application Number

7883

Product Number

3

Dosage Form

-

Strength

250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

-
Unclassified Application: 210142

Drug Name

APIXABAN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

-

210142 / 1

Active Ingredient

APIXABAN

Application Number

210142

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

-

Regulatory Status

Unclassified

2022
18 Aug
Discontinued Application: 211897

Drug Name

APREMILAST

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2022-08-18

211897 / 1

Active Ingredient

APREMILAST

Application Number

211897

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2022-08-18

Regulatory Status

Discontinued

2022
18 Aug
Discontinued Application: 211897

Drug Name

APREMILAST

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2022-08-18

211897 / 2

Active Ingredient

APREMILAST

Application Number

211897

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2022-08-18

Regulatory Status

Discontinued

2022
18 Aug
Discontinued Application: 211897

Drug Name

APREMILAST

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2022-08-18

211897 / 3

Active Ingredient

APREMILAST

Application Number

211897

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2022-08-18

Regulatory Status

Discontinued

2021
09 Nov
Discontinued Application: 200293

Drug Name

ARFORMOTEROL TARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 0.015MG BASE/2ML

Approval Date

2021-11-09

200293 / 1

Active Ingredient

ARFORMOTEROL TARTRATE

Application Number

200293

Product Number

1

Dosage Form

-

Strength

EQ 0.015MG BASE/2ML

Approval Date

2021-11-09

Regulatory Status

Discontinued

2014
15 Dec
Discontinued Application: 206769

Drug Name

ARGATROBAN IN 0.9% SODIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG/250ML (1MG/ML)

Approval Date

2014-12-15

206769 / 1

Active Ingredient

ARGATROBAN

Application Number

206769

Product Number

1

Dosage Form

-

Strength

250MG/250ML (1MG/ML)

Approval Date

2014-12-15

Regulatory Status

Discontinued

2015
28 Apr
Discontinued Application: 78607

Drug Name

ARIPIPRAZOLE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2015-04-28

78607 / 1

Active Ingredient

ARIPIPRAZOLE

Application Number

78607

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2015-04-28

Regulatory Status

Discontinued

2015
28 Apr
Discontinued Application: 78607

Drug Name

ARIPIPRAZOLE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2015-04-28

78607 / 2

Active Ingredient

ARIPIPRAZOLE

Application Number

78607

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2015-04-28

Regulatory Status

Discontinued

2015
28 Apr
Discontinued Application: 78608

Drug Name

ARIPIPRAZOLE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2015-04-28

78608 / 1

Active Ingredient

ARIPIPRAZOLE

Application Number

78608

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2015-04-28

Regulatory Status

Discontinued

2015
28 Apr
Discontinued Application: 78708

Drug Name

ARIPIPRAZOLE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2015-04-28

78708 / 1

Active Ingredient

ARIPIPRAZOLE

Application Number

78708

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2015-04-28

Regulatory Status

Discontinued

2015
28 Apr
Discontinued Application: 78708

Drug Name

ARIPIPRAZOLE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2015-04-28

78708 / 2

Active Ingredient

ARIPIPRAZOLE

Application Number

78708

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2015-04-28

Regulatory Status

Discontinued

2015
28 Apr
Discontinued Application: 78708

Drug Name

ARIPIPRAZOLE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2015-04-28

78708 / 3

Active Ingredient

ARIPIPRAZOLE

Application Number

78708

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2015-04-28

Regulatory Status

Discontinued

-
Unclassified Application: 200152

Drug Name

ARMODAFINIL

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

200152 / 1

Active Ingredient

ARMODAFINIL

Application Number

200152

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 200152

Drug Name

ARMODAFINIL

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

200152 / 2

Active Ingredient

ARMODAFINIL

Application Number

200152

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 200152

Drug Name

ARMODAFINIL

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

-

200152 / 3

Active Ingredient

ARMODAFINIL

Application Number

200152

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 200152

Drug Name

ARMODAFINIL

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

-

200152 / 4

Active Ingredient

ARMODAFINIL

Application Number

200152

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 200152

Drug Name

ARMODAFINIL

Product Number

5

Dosage Form

-

Strength

250MG

Approval Date

-

200152 / 5

Active Ingredient

ARMODAFINIL

Application Number

200152

Product Number

5

Dosage Form

-

Strength

250MG

Approval Date

-

Regulatory Status

Unclassified

2020
20 Feb
Discontinued Application: 208798

Drug Name

ARMONAIR DIGIHALER

Product Number

4

Dosage Form

-

Strength

0.055MG/INH

Approval Date

2020-02-20

208798 / 4

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

208798

Product Number

4

Dosage Form

-

Strength

0.055MG/INH

Approval Date

2020-02-20

Regulatory Status

Discontinued

2020
20 Feb
Discontinued Application: 208798

Drug Name

ARMONAIR DIGIHALER

Product Number

5

Dosage Form

-

Strength

0.113MG/INH

Approval Date

2020-02-20

208798 / 5

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

208798

Product Number

5

Dosage Form

-

Strength

0.113MG/INH

Approval Date

2020-02-20

Regulatory Status

Discontinued

2020
20 Feb
Discontinued Application: 208798

Drug Name

ARMONAIR DIGIHALER

Product Number

6

Dosage Form

-

Strength

0.232MG/INH

Approval Date

2020-02-20

208798 / 6

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

208798

Product Number

6

Dosage Form

-

Strength

0.232MG/INH

Approval Date

2020-02-20

Regulatory Status

Discontinued

2022
08 Apr
Discontinued Application: 208798

Drug Name

ARMONAIR DIGIHALER

Product Number

8

Dosage Form

-

Strength

0.03MG/INH

Approval Date

2022-04-08

208798 / 8

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

208798

Product Number

8

Dosage Form

-

Strength

0.03MG/INH

Approval Date

2022-04-08

Regulatory Status

Discontinued

2017
27 Jan
Discontinued Application: 208798

Drug Name

ARMONAIR RESPICLICK

Product Number

1

Dosage Form

-

Strength

0.055MG/INH

Approval Date

2017-01-27

208798 / 1

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

208798

Product Number

1

Dosage Form

-

Strength

0.055MG/INH

Approval Date

2017-01-27

Regulatory Status

Discontinued

2017
27 Jan
Discontinued Application: 208798

Drug Name

ARMONAIR RESPICLICK

Product Number

2

Dosage Form

-

Strength

0.113MG/INH

Approval Date

2017-01-27

208798 / 2

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

208798

Product Number

2

Dosage Form

-

Strength

0.113MG/INH

Approval Date

2017-01-27

Regulatory Status

Discontinued

2017
27 Jan
Discontinued Application: 208798

Drug Name

ARMONAIR RESPICLICK

Product Number

3

Dosage Form

-

Strength

0.232MG/INH

Approval Date

2017-01-27

208798 / 3

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

208798

Product Number

3

Dosage Form

-

Strength

0.232MG/INH

Approval Date

2017-01-27

Regulatory Status

Discontinued

2021
09 Jul
Discontinued Application: 208798

Drug Name

ARMONAIR RESPICLICK

Product Number

7

Dosage Form

-

Strength

0.03MG/INH

Approval Date

2021-07-09

208798 / 7

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

208798

Product Number

7

Dosage Form

-

Strength

0.03MG/INH

Approval Date

2021-07-09

Regulatory Status

Discontinued

-
Unclassified Application: 78729

Drug Name

ARSENIC TRIOXIDE

Product Number

1

Dosage Form

-

Strength

10ML

Approval Date

-

78729 / 1

Active Ingredient

ARSENIC TRIOXIDE

Application Number

78729

Product Number

1

Dosage Form

-

Strength

10ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 209791

Drug Name

ASPIRIN; OMEPRAZOLE

Product Number

1

Dosage Form

-

Strength

81MG;40MG

Approval Date

-

209791 / 1

Active Ingredient

ASPIRIN;OMEPRAZOLE

Application Number

209791

Product Number

1

Dosage Form

-

Strength

81MG;40MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 209791

Drug Name

ASPIRIN; OMEPRAZOLE

Product Number

2

Dosage Form

-

Strength

325MG;40MG

Approval Date

-

209791 / 2

Active Ingredient

ASPIRIN;OMEPRAZOLE

Application Number

209791

Product Number

2

Dosage Form

-

Strength

325MG;40MG

Approval Date

-

Regulatory Status

Unclassified

2014
22 Apr
RX Application: 91673

Drug Name

ATAZANAVIR SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2014-04-22

91673 / 1

Active Ingredient

ATAZANAVIR SULFATE

Application Number

91673

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2014-04-22

Regulatory Status

RX

2014
22 Apr
RX Application: 91673

Drug Name

ATAZANAVIR SULFATE

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2014-04-22

91673 / 2

Active Ingredient

ATAZANAVIR SULFATE

Application Number

91673

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2014-04-22

Regulatory Status

RX

2014
22 Apr
RX Application: 91673

Drug Name

ATAZANAVIR SULFATE

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2014-04-22

91673 / 3

Active Ingredient

ATAZANAVIR SULFATE

Application Number

91673

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2014-04-22

Regulatory Status

RX

2014
22 Apr
RX Application: 91673

Drug Name

ATAZANAVIR SULFATE

Product Number

4

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2014-04-22

91673 / 4

Active Ingredient

ATAZANAVIR SULFATE

Application Number

91673

Product Number

4

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2014-04-22

Regulatory Status

RX

1995
24 Feb
Discontinued Application: 74120

Drug Name

ATENOLOL

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1995-02-24

74120 / 1

Active Ingredient

ATENOLOL

Application Number

74120

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1995-02-24

Regulatory Status

Discontinued

1995
24 Feb
Discontinued Application: 74120

Drug Name

ATENOLOL

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1995-02-24

74120 / 2

Active Ingredient

ATENOLOL

Application Number

74120

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1995-02-24

Regulatory Status

Discontinued

2017
30 May
RX Application: 79022

Drug Name

ATOMOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2017-05-30

79022 / 1

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

79022

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2017-05-30

Regulatory Status

RX

2017
30 May
RX Application: 79022

Drug Name

ATOMOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 18MG BASE

Approval Date

2017-05-30

79022 / 2

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

79022

Product Number

2

Dosage Form

-

Strength

EQ 18MG BASE

Approval Date

2017-05-30

Regulatory Status

RX

2017
30 May
RX Application: 79022

Drug Name

ATOMOXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2017-05-30

79022 / 3

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

79022

Product Number

3

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2017-05-30

Regulatory Status

RX

2017
30 May
RX Application: 79022

Drug Name

ATOMOXETINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2017-05-30

79022 / 4

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

79022

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2017-05-30

Regulatory Status

RX

2017
30 May
RX Application: 79022

Drug Name

ATOMOXETINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2017-05-30

79022 / 5

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

79022

Product Number

5

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2017-05-30

Regulatory Status

RX

2017
30 May
RX Application: 79022

Drug Name

ATOMOXETINE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2017-05-30

79022 / 6

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

79022

Product Number

6

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2017-05-30

Regulatory Status

RX

2017
30 May
RX Application: 79022

Drug Name

ATOMOXETINE HYDROCHLORIDE

Product Number

7

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2017-05-30

79022 / 7

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

79022

Product Number

7

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2017-05-30

Regulatory Status

RX

2012
29 May
Discontinued Application: 78773

Drug Name

ATORVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-05-29

78773 / 1

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

78773

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-05-29

Regulatory Status

Discontinued

2012
29 May
Discontinued Application: 78773

Drug Name

ATORVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-05-29

78773 / 2

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

78773

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-05-29

Regulatory Status

Discontinued

2012
29 May
Discontinued Application: 78773

Drug Name

ATORVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2012-05-29

78773 / 3

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

78773

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2012-05-29

Regulatory Status

Discontinued

2012
29 May
Discontinued Application: 78773

Drug Name

ATORVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2012-05-29

78773 / 4

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

78773

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2012-05-29

Regulatory Status

Discontinued

2017
27 Mar
RX Application: 205300

Drug Name

ATORVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2017-03-27

205300 / 1

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

205300

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2017-03-27

Regulatory Status

RX

2017
27 Mar
RX Application: 205300

Drug Name

ATORVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2017-03-27

205300 / 2

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

205300

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2017-03-27

Regulatory Status

RX

2017
27 Mar
RX Application: 205300

Drug Name

ATORVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2017-03-27

205300 / 3

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

205300

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2017-03-27

Regulatory Status

RX

2017
27 Mar
RX Application: 205300

Drug Name

ATORVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2017-03-27

205300 / 4

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

205300

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2017-03-27

Regulatory Status

RX

2017
03 Apr
RX Application: 208082

Drug Name

AUSTEDO

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

2017-04-03

208082 / 1

Active Ingredient

DEUTETRABENAZINE

Application Number

208082

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

2017-04-03

Regulatory Status

RX

2017
03 Apr
RX Application: 208082

Drug Name

AUSTEDO

Product Number

2

Dosage Form

-

Strength

9MG

Approval Date

2017-04-03

208082 / 2

Active Ingredient

DEUTETRABENAZINE

Application Number

208082

Product Number

2

Dosage Form

-

Strength

9MG

Approval Date

2017-04-03

Regulatory Status

RX

2017
03 Apr
RX Application: 208082

Drug Name

AUSTEDO

Product Number

3

Dosage Form

-

Strength

12MG

Approval Date

2017-04-03

208082 / 3

Active Ingredient

DEUTETRABENAZINE

Application Number

208082

Product Number

3

Dosage Form

-

Strength

12MG

Approval Date

2017-04-03

Regulatory Status

RX

-
Unclassified Application: 209885

Drug Name

AUSTEDO

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

-

209885 / 1

Active Ingredient

DEUTETRABENAZINE

Application Number

209885

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 209885

Drug Name

AUSTEDO

Product Number

2

Dosage Form

-

Strength

9MG

Approval Date

-

209885 / 2

Active Ingredient

DEUTETRABENAZINE

Application Number

209885

Product Number

2

Dosage Form

-

Strength

9MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 209885

Drug Name

AUSTEDO

Product Number

3

Dosage Form

-

Strength

12MG

Approval Date

-

209885 / 3

Active Ingredient

DEUTETRABENAZINE

Application Number

209885

Product Number

3

Dosage Form

-

Strength

12MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 210234

Drug Name

AXITINIB

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

-

210234 / 1

Active Ingredient

AXITINIB

Application Number

210234

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 210234

Drug Name

AXITINIB

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

-

210234 / 2

Active Ingredient

AXITINIB

Application Number

210234

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

-

Regulatory Status

Unclassified

2025
08 Apr
RX Application: 208436

Drug Name

AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.137MG/SPRAY;0.05MG/SPRAY

Approval Date

2025-04-08

208436 / 1

Active Ingredient

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

Application Number

208436

Product Number

1

Dosage Form

-

Strength

0.137MG/SPRAY;0.05MG/SPRAY

Approval Date

2025-04-08

Regulatory Status

RX

2008
24 Jun
Discontinued Application: 65419

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/5ML

Approval Date

2008-06-24

65419 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65419

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/5ML

Approval Date

2008-06-24

Regulatory Status

Discontinued

2008
24 Jun
Discontinued Application: 65419

Drug Name

AZITHROMYCIN

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

2008-06-24

65419 / 2

Active Ingredient

AZITHROMYCIN

Application Number

65419

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

2008-06-24

Regulatory Status

Discontinued

1988
22 Apr
Discontinued Application: 71883

Drug Name

BETAMETHASONE VALERATE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1988-04-22

71883 / 1

Active Ingredient

BETAMETHASONE VALERATE

Application Number

71883

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1988-04-22

Regulatory Status

Discontinued

2021
14 Jan
RX Application: 209931

Drug Name

BEXAROTENE

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2021-01-14

209931 / 1

Active Ingredient

BEXAROTENE

Application Number

209931

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2021-01-14

Regulatory Status

RX

2001
26 Jun
Discontinued Application: 75644

Drug Name

BISOPROLOL FUMARATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2001-06-26

75644 / 1

Active Ingredient

BISOPROLOL FUMARATE

Application Number

75644

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2001-06-26

Regulatory Status

Discontinued

2001
26 Jun
Discontinued Application: 75644

Drug Name

BISOPROLOL FUMARATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2001-06-26

75644 / 2

Active Ingredient

BISOPROLOL FUMARATE

Application Number

75644

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2001-06-26

Regulatory Status

Discontinued

2000
27 Jun
Discontinued Application: 65033

Drug Name

BLEOMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 15 UNITS BASE/VIAL

Approval Date

2000-06-27

65033 / 1

Active Ingredient

BLEOMYCIN SULFATE

Application Number

65033

Product Number

1

Dosage Form

-

Strength

EQ 15 UNITS BASE/VIAL

Approval Date

2000-06-27

Regulatory Status

Discontinued

2000
27 Jun
Discontinued Application: 65033

Drug Name

BLEOMYCIN SULFATE

Product Number

2

Dosage Form

-

Strength

EQ 30 UNITS BASE/VIAL

Approval Date

2000-06-27

65033 / 2

Active Ingredient

BLEOMYCIN SULFATE

Application Number

65033

Product Number

2

Dosage Form

-

Strength

EQ 30 UNITS BASE/VIAL

Approval Date

2000-06-27

Regulatory Status

Discontinued

2022
02 May
Discontinued Application: 205857

Drug Name

BORTEZOMIB

Product Number

1

Dosage Form

-

Strength

3.5MG/VIAL

Approval Date

2022-05-02

205857 / 1

Active Ingredient

BORTEZOMIB

Application Number

205857

Product Number

1

Dosage Form

-

Strength

3.5MG/VIAL

Approval Date

2022-05-02

Regulatory Status

Discontinued

2022
11 Aug
Discontinued Application: 213692

Drug Name

BREXPIPRAZOLE

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2022-08-11

213692 / 1

Active Ingredient

BREXPIPRAZOLE

Application Number

213692

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2022-08-11

Regulatory Status

Discontinued

2022
11 Aug
Discontinued Application: 213692

Drug Name

BREXPIPRAZOLE

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2022-08-11

213692 / 2

Active Ingredient

BREXPIPRAZOLE

Application Number

213692

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2022-08-11

Regulatory Status

Discontinued

2022
11 Aug
Discontinued Application: 213692

Drug Name

BREXPIPRAZOLE

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2022-08-11

213692 / 3

Active Ingredient

BREXPIPRAZOLE

Application Number

213692

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2022-08-11

Regulatory Status

Discontinued

2022
11 Aug
Discontinued Application: 213692

Drug Name

BREXPIPRAZOLE

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2022-08-11

213692 / 4

Active Ingredient

BREXPIPRAZOLE

Application Number

213692

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2022-08-11

Regulatory Status

Discontinued

2022
11 Aug
Discontinued Application: 213692

Drug Name

BREXPIPRAZOLE

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2022-08-11

213692 / 5

Active Ingredient

BREXPIPRAZOLE

Application Number

213692

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2022-08-11

Regulatory Status

Discontinued

2022
11 Aug
Discontinued Application: 213692

Drug Name

BREXPIPRAZOLE

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2022-08-11

213692 / 6

Active Ingredient

BREXPIPRAZOLE

Application Number

213692

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2022-08-11

Regulatory Status

Discontinued

2008
18 Nov
RX Application: 77519

Drug Name

BUDESONIDE

Product Number

1

Dosage Form

-

Strength

0.25MG/2ML

Approval Date

2008-11-18

77519 / 1

Active Ingredient

BUDESONIDE

Application Number

77519

Product Number

1

Dosage Form

-

Strength

0.25MG/2ML

Approval Date

2008-11-18

Regulatory Status

RX

2008
18 Nov
RX Application: 77519

Drug Name

BUDESONIDE

Product Number

2

Dosage Form

-

Strength

0.5MG/2ML

Approval Date

2008-11-18

77519 / 2

Active Ingredient

BUDESONIDE

Application Number

77519

Product Number

2

Dosage Form

-

Strength

0.5MG/2ML

Approval Date

2008-11-18

Regulatory Status

RX

2016
08 Mar
RX Application: 204548

Drug Name

BUDESONIDE

Product Number

1

Dosage Form

-

Strength

1MG/2ML

Approval Date

2016-03-08

204548 / 1

Active Ingredient

BUDESONIDE

Application Number

204548

Product Number

1

Dosage Form

-

Strength

1MG/2ML

Approval Date

2016-03-08

Regulatory Status

RX

2026
23 Apr
RX Application: 212212

Drug Name

BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE

Product Number

1

Dosage Form

-

Strength

0.08MG/INH;0.0045MG/INH

Approval Date

2026-04-23

212212 / 1

Active Ingredient

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

Application Number

212212

Product Number

1

Dosage Form

-

Strength

0.08MG/INH;0.0045MG/INH

Approval Date

2026-04-23

Regulatory Status

RX

2026
23 Apr
RX Application: 212212

Drug Name

BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE

Product Number

2

Dosage Form

-

Strength

0.16MG/INH;0.0045MG/INH

Approval Date

2026-04-23

212212 / 2

Active Ingredient

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

Application Number

212212

Product Number

2

Dosage Form

-

Strength

0.16MG/INH;0.0045MG/INH

Approval Date

2026-04-23

Regulatory Status

RX

2014
08 Sep
Discontinued Application: 91149

Drug Name

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE;EQ 0.5MG BASE

Approval Date

2014-09-08

91149 / 1

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

91149

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE;EQ 0.5MG BASE

Approval Date

2014-09-08

Regulatory Status

Discontinued

2014
08 Sep
Discontinued Application: 91149

Drug Name

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE;EQ 2MG BASE

Approval Date

2014-09-08

91149 / 2

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

91149

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE;EQ 2MG BASE

Approval Date

2014-09-08

Regulatory Status

Discontinued

-
Unclassified Application: 210451

Drug Name

CANAGLIFLOZIN

Product Number

2

Dosage Form

-

Strength

300mg

Approval Date

-

210451 / 2

Active Ingredient

CANAGLIFLOZIN

Application Number

210451

Product Number

2

Dosage Form

-

Strength

300mg

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 200887

Drug Name

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

16MG; 12.5MG

Approval Date

-

200887 / 1

Active Ingredient

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Application Number

200887

Product Number

1

Dosage Form

-

Strength

16MG; 12.5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 200887

Drug Name

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

32MG; 12.5MG

Approval Date

-

200887 / 2

Active Ingredient

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Application Number

200887

Product Number

2

Dosage Form

-

Strength

32MG; 12.5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 200887

Drug Name

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

32MG; 25MG

Approval Date

-

200887 / 3

Active Ingredient

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Application Number

200887

Product Number

3

Dosage Form

-

Strength

32MG; 25MG

Approval Date

-

Regulatory Status

Unclassified

2013
16 Sep
RX Application: 91649

Drug Name

CAPECITABINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2013-09-16

91649 / 1

Active Ingredient

CAPECITABINE

Application Number

91649

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2013-09-16

Regulatory Status

RX

2013
16 Sep
RX Application: 91649

Drug Name

CAPECITABINE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2013-09-16

91649 / 2

Active Ingredient

CAPECITABINE

Application Number

91649

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2013-09-16

Regulatory Status

RX

2012
20 Sep
RX Application: 78592

Drug Name

CARBAMAZEPINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2012-09-20

78592 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

78592

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2012-09-20

Regulatory Status

RX

2012
20 Sep
RX Application: 78592

Drug Name

CARBAMAZEPINE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2012-09-20

78592 / 2

Active Ingredient

CARBAMAZEPINE

Application Number

78592

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2012-09-20

Regulatory Status

RX

2012
20 Sep
RX Application: 78592

Drug Name

CARBAMAZEPINE

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2012-09-20

78592 / 3

Active Ingredient

CARBAMAZEPINE

Application Number

78592

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2012-09-20

Regulatory Status

RX

-
Unclassified Application: 78746

Drug Name

CARBAMAZEPINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

-

78746 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

78746

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 78746

Drug Name

CARBAMAZEPINE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

-

78746 / 2

Active Ingredient

CARBAMAZEPINE

Application Number

78746

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 78746

Drug Name

CARBAMAZEPINE

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

-

78746 / 3

Active Ingredient

CARBAMAZEPINE

Application Number

78746

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

-

Regulatory Status

Unclassified

2005
21 Sep
Discontinued Application: 77139

Drug Name

CARBOPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2005-09-21

77139 / 1

Active Ingredient

CARBOPLATIN

Application Number

77139

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2005-09-21

Regulatory Status

Discontinued

2005
21 Sep
Discontinued Application: 77139

Drug Name

CARBOPLATIN

Product Number

2

Dosage Form

-

Strength

150MG/15ML (10MG/ML)

Approval Date

2005-09-21

77139 / 2

Active Ingredient

CARBOPLATIN

Application Number

77139

Product Number

2

Dosage Form

-

Strength

150MG/15ML (10MG/ML)

Approval Date

2005-09-21

Regulatory Status

Discontinued

2005
21 Sep
Discontinued Application: 77139

Drug Name

CARBOPLATIN

Product Number

3

Dosage Form

-

Strength

450MG/45ML (10MG/ML)

Approval Date

2005-09-21

77139 / 3

Active Ingredient

CARBOPLATIN

Application Number

77139

Product Number

3

Dosage Form

-

Strength

450MG/45ML (10MG/ML)

Approval Date

2005-09-21

Regulatory Status

Discontinued

2005
21 Sep
Discontinued Application: 77139

Drug Name

CARBOPLATIN

Product Number

4

Dosage Form

-

Strength

600MG/60ML (10MG/ML)

Approval Date

2005-09-21

77139 / 4

Active Ingredient

CARBOPLATIN

Application Number

77139

Product Number

4

Dosage Form

-

Strength

600MG/60ML (10MG/ML)

Approval Date

2005-09-21

Regulatory Status

Discontinued

2018
07 Sep
Discontinued Application: 208042

Drug Name

CASSIPA

Product Number

1

Dosage Form

-

Strength

EQ 16MG BASE;EQ 4MG BASE

Approval Date

2018-09-07

208042 / 1

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

208042

Product Number

1

Dosage Form

-

Strength

EQ 16MG BASE;EQ 4MG BASE

Approval Date

2018-09-07

Regulatory Status

Discontinued

1987
08 Apr
RX Application: 62774

Drug Name

CEFADROXIL

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

1987-04-08

62774 / 1

Active Ingredient

CEFADROXIL/CEFADROXIL HEMIHYDRATE

Application Number

62774

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

1987-04-08

Regulatory Status

RX

2006
20 Jan
RX Application: 65282

Drug Name

CEFADROXIL

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2006-01-20

65282 / 1

Active Ingredient

CEFADROXIL/CEFADROXIL HEMIHYDRATE

Application Number

65282

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2006-01-20

Regulatory Status

RX

1989
14 Mar
Discontinued Application: 63016

Drug Name

CEFAZOLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1989-03-14

63016 / 1

Active Ingredient

CEFAZOLIN SODIUM

Application Number

63016

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1989-03-14

Regulatory Status

Discontinued

1989
14 Mar
Discontinued Application: 63016

Drug Name

CEFAZOLIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1989-03-14

63016 / 2

Active Ingredient

CEFAZOLIN SODIUM

Application Number

63016

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1989-03-14

Regulatory Status

Discontinued

1989
14 Mar
Discontinued Application: 63016

Drug Name

CEFAZOLIN SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1989-03-14

63016 / 3

Active Ingredient

CEFAZOLIN SODIUM

Application Number

63016

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1989-03-14

Regulatory Status

Discontinued

1990
05 Mar
Discontinued Application: 63018

Drug Name

CEFAZOLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 5GM BASE/VIAL

Approval Date

1990-03-05

63018 / 1

Active Ingredient

CEFAZOLIN SODIUM

Application Number

63018

Product Number

1

Dosage Form

-

Strength

EQ 5GM BASE/VIAL

Approval Date

1990-03-05

Regulatory Status

Discontinued

1990
05 Mar
Discontinued Application: 63018

Drug Name

CEFAZOLIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1990-03-05

63018 / 2

Active Ingredient

CEFAZOLIN SODIUM

Application Number

63018

Product Number

2

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1990-03-05

Regulatory Status

Discontinued

2007
04 May
RX Application: 65332

Drug Name

CEFDINIR

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

2007-05-04

65332 / 1

Active Ingredient

CEFDINIR

Application Number

65332

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

2007-05-04

Regulatory Status

RX

2007
04 May
RX Application: 65332

Drug Name

CEFDINIR

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

2007-05-04

65332 / 2

Active Ingredient

CEFDINIR

Application Number

65332

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

2007-05-04

Regulatory Status

RX

2007
09 May
RX Application: 65368

Drug Name

CEFDINIR

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2007-05-09

65368 / 1

Active Ingredient

CEFDINIR

Application Number

65368

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2007-05-09

Regulatory Status

RX

2007
15 Mar
Discontinued Application: 65227

Drug Name

CEFTRIAXONE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2007-03-15

65227 / 1

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65227

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2007-03-15

Regulatory Status

Discontinued

2007
15 Mar
Discontinued Application: 65227

Drug Name

CEFTRIAXONE

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2007-03-15

65227 / 2

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65227

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2007-03-15

Regulatory Status

Discontinued

2007
15 Mar
Discontinued Application: 65227

Drug Name

CEFTRIAXONE

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2007-03-15

65227 / 3

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65227

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2007-03-15

Regulatory Status

Discontinued

2007
15 Mar
Discontinued Application: 65227

Drug Name

CEFTRIAXONE

Product Number

4

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2007-03-15

65227 / 4

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65227

Product Number

4

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2007-03-15

Regulatory Status

Discontinued

1998
16 Apr
Discontinued Application: 64191

Drug Name

CEFUROXIME SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 7.5GM BASE/VIAL

Approval Date

1998-04-16

64191 / 1

Active Ingredient

CEFUROXIME SODIUM

Application Number

64191

Product Number

1

Dosage Form

-

Strength

EQ 7.5GM BASE/VIAL

Approval Date

1998-04-16

Regulatory Status

Discontinued

1998
16 Apr
Discontinued Application: 64192

Drug Name

CEFUROXIME SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 1.5GM BASE/VIAL

Approval Date

1998-04-16

64192 / 1

Active Ingredient

CEFUROXIME SODIUM

Application Number

64192

Product Number

1

Dosage Form

-

Strength

EQ 1.5GM BASE/VIAL

Approval Date

1998-04-16

Regulatory Status

Discontinued

1998
16 Apr
Discontinued Application: 64192

Drug Name

CEFUROXIME SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

1998-04-16

64192 / 2

Active Ingredient

CEFUROXIME SODIUM

Application Number

64192

Product Number

2

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

1998-04-16

Regulatory Status

Discontinued

2008
27 May
Discontinued Application: 77279

Drug Name

CETIRIZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2008-05-27

77279 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

77279

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2008-05-27

Regulatory Status

Discontinued

2021
02 Nov
Discontinued Application: 211476

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

5MG;2.5MG

Approval Date

2021-11-02

211476 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE

Application Number

211476

Product Number

1

Dosage Form

-

Strength

5MG;2.5MG

Approval Date

2021-11-02

Regulatory Status

Discontinued

2021
25 Oct
RX Application: 215659

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-10-25

215659 / 1

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

215659

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-10-25

Regulatory Status

RX

2021
25 Oct
RX Application: 215659

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2021-10-25

215659 / 2

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

215659

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2021-10-25

Regulatory Status

RX

2021
25 Oct
RX Application: 215659

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2021-10-25

215659 / 3

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

215659

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2021-10-25

Regulatory Status

RX

2021
25 Oct
RX Application: 215659

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2021-10-25

215659 / 4

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

215659

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2021-10-25

Regulatory Status

RX

2021
25 Oct
RX Application: 215659

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

200MG

Approval Date

2021-10-25

215659 / 5

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

215659

Product Number

5

Dosage Form

-

Strength

200MG

Approval Date

2021-10-25

Regulatory Status

RX

2020
17 Jun
Discontinued Application: 212898

Drug Name

CHLORZOXAZONE

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

2020-06-17

212898 / 1

Active Ingredient

CHLORZOXAZONE

Application Number

212898

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

2020-06-17

Regulatory Status

Discontinued

2020
17 Jun
Discontinued Application: 212898

Drug Name

CHLORZOXAZONE

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2020-06-17

212898 / 2

Active Ingredient

CHLORZOXAZONE

Application Number

212898

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2020-06-17

Regulatory Status

Discontinued

1998
30 Sep
Discontinued Application: 74555

Drug Name

CHOLESTYRAMINE LIGHT

Product Number

1

Dosage Form

-

Strength

EQ 4GM RESIN/PACKET

Approval Date

1998-09-30

74555 / 1

Active Ingredient

CHOLESTYRAMINE

Application Number

74555

Product Number

1

Dosage Form

-

Strength

EQ 4GM RESIN/PACKET

Approval Date

1998-09-30

Regulatory Status

Discontinued

1998
30 Sep
Discontinued Application: 74555

Drug Name

CHOLESTYRAMINE LIGHT

Product Number

2

Dosage Form

-

Strength

EQ 4GM RESIN/SCOOPFUL

Approval Date

1998-09-30

74555 / 2

Active Ingredient

CHOLESTYRAMINE

Application Number

74555

Product Number

2

Dosage Form

-

Strength

EQ 4GM RESIN/SCOOPFUL

Approval Date

1998-09-30

Regulatory Status

Discontinued

2007
18 Sep
Discontinued Application: 78079

Drug Name

CICLOPIROX

Product Number

1

Dosage Form

-

Strength

8%

Approval Date

2007-09-18

78079 / 1

Active Ingredient

CICLOPIROX

Application Number

78079

Product Number

1

Dosage Form

-

Strength

8%

Approval Date

2007-09-18

Regulatory Status

Discontinued

-
Unclassified Application: 90539

Drug Name

CINACALCET HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

-

90539 / 1

Active Ingredient

CINACALCET HYDROCHLORIDE

Application Number

90539

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

-

Regulatory Status

Unclassified

2008
18 Mar
Discontinued Application: 77138

Drug Name

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

200MG/100ML

Approval Date

2008-03-18

77138 / 1

Active Ingredient

CIPROFLOXACIN

Application Number

77138

Product Number

1

Dosage Form

-

Strength

200MG/100ML

Approval Date

2008-03-18

Regulatory Status

Discontinued

2008
18 Mar
Discontinued Application: 77138

Drug Name

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

400MG/200ML

Approval Date

2008-03-18

77138 / 2

Active Ingredient

CIPROFLOXACIN

Application Number

77138

Product Number

2

Dosage Form

-

Strength

400MG/200ML

Approval Date

2008-03-18

Regulatory Status

Discontinued

2000
16 May
Discontinued Application: 74814

Drug Name

CISPLATIN

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2000-05-16

74814 / 1

Active Ingredient

CISPLATIN

Application Number

74814

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2000-05-16

Regulatory Status

Discontinued

2003
11 Apr
RX Application: 76135

Drug Name

CLARAVIS

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2003-04-11

76135 / 1

Active Ingredient

ISOTRETINOIN

Application Number

76135

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2003-04-11

Regulatory Status

RX

2003
11 Apr
RX Application: 76135

Drug Name

CLARAVIS

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2003-04-11

76135 / 2

Active Ingredient

ISOTRETINOIN

Application Number

76135

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2003-04-11

Regulatory Status

RX

2006
11 May
RX Application: 76135

Drug Name

CLARAVIS

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2006-05-11

76135 / 3

Active Ingredient

ISOTRETINOIN

Application Number

76135

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2006-05-11

Regulatory Status

RX

2003
11 Apr
RX Application: 76356

Drug Name

CLARAVIS

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2003-04-11

76356 / 1

Active Ingredient

ISOTRETINOIN

Application Number

76356

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2003-04-11

Regulatory Status

RX

1992
21 Apr
Discontinued Application: 73095

Drug Name

CLEMASTINE FUMARATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE/5ML

Approval Date

1992-04-21

73095 / 1

Active Ingredient

CLEMASTINE FUMARATE

Application Number

73095

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE/5ML

Approval Date

1992-04-21

Regulatory Status

Discontinued

2020
31 Jan
Discontinued Application: 211032

Drug Name

CLOBAZAM

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2020-01-31

211032 / 1

Active Ingredient

CLOBAZAM

Application Number

211032

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2020-01-31

Regulatory Status

Discontinued

1994
16 Feb
Discontinued Application: 74087

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1994-02-16

74087 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

74087

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1994-02-16

Regulatory Status

Discontinued

1990
13 Dec
Discontinued Application: 19795

Drug Name

CONDYLOX

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1990-12-13

19795 / 1

Active Ingredient

PODOFILOX

Application Number

19795

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1990-12-13

Regulatory Status

Discontinued

1996
20 Dec
Discontinued Application: 20622

Drug Name

COPAXONE

Product Number

1

Dosage Form

-

Strength

20MG/VIAL

Approval Date

1996-12-20

20622 / 1

Active Ingredient

GLATIRAMER ACETATE

Application Number

20622

Product Number

1

Dosage Form

-

Strength

20MG/VIAL

Approval Date

1996-12-20

Regulatory Status

Discontinued

2002
12 Feb
RX Application: 20622

Drug Name

COPAXONE

Product Number

2

Dosage Form

-

Strength

20MG/ML

Approval Date

2002-02-12

20622 / 2

Active Ingredient

GLATIRAMER ACETATE

Application Number

20622

Product Number

2

Dosage Form

-

Strength

20MG/ML

Approval Date

2002-02-12

Regulatory Status

RX

2014
28 Jan
RX Application: 20622

Drug Name

COPAXONE

Product Number

3

Dosage Form

-

Strength

40MG/ML

Approval Date

2014-01-28

20622 / 3

Active Ingredient

GLATIRAMER ACETATE

Application Number

20622

Product Number

3

Dosage Form

-

Strength

40MG/ML

Approval Date

2014-01-28

Regulatory Status

RX

2000
18 Jan
RX Application: 75271

Drug Name

CROMOLYN SODIUM

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2000-01-18

75271 / 1

Active Ingredient

CROMOLYN SODIUM

Application Number

75271

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2000-01-18

Regulatory Status

RX

2023
14 Dec
RX Application: 203880

Drug Name

CYCLOSPORINE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2023-12-14

203880 / 1

Active Ingredient

CYCLOSPORINE

Application Number

203880

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2023-12-14

Regulatory Status

RX

1998
30 Dec
Discontinued Application: 75206

Drug Name

CYTOSAR-U

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

1998-12-30

75206 / 1

Active Ingredient

CYTARABINE

Application Number

75206

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

1998-12-30

Regulatory Status

Discontinued

1998
30 Dec
Discontinued Application: 75206

Drug Name

CYTOSAR-U

Product Number

2

Dosage Form

-

Strength

500MG/VIAL

Approval Date

1998-12-30

75206 / 2

Active Ingredient

CYTARABINE

Application Number

75206

Product Number

2

Dosage Form

-

Strength

500MG/VIAL

Approval Date

1998-12-30

Regulatory Status

Discontinued

1998
30 Dec
Discontinued Application: 75206

Drug Name

CYTOSAR-U

Product Number

3

Dosage Form

-

Strength

2GM/VIAL

Approval Date

1998-12-30

75206 / 3

Active Ingredient

CYTARABINE

Application Number

75206

Product Number

3

Dosage Form

-

Strength

2GM/VIAL

Approval Date

1998-12-30

Regulatory Status

Discontinued

1998
30 Dec
Discontinued Application: 75206

Drug Name

CYTOSAR-U

Product Number

4

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1998-12-30

75206 / 4

Active Ingredient

CYTARABINE

Application Number

75206

Product Number

4

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1998-12-30

Regulatory Status

Discontinued

-
Unclassified Application: 208057

Drug Name

DABIGATRAN ETEXILATE MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

-

208057 / 1

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

208057

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 208057

Drug Name

DABIGATRAN ETEXILATE MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 110MG BASE

Approval Date

-

208057 / 2

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

208057

Product Number

2

Dosage Form

-

Strength

EQ 110MG BASE

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 208057

Drug Name

DABIGATRAN ETEXILATE MESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

-

208057 / 3

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

208057

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 206854

Drug Name

DALFAMPRIDINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

-

206854 / 1

Active Ingredient

DALFAMPRIDINE

Application Number

206854

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

2026
06 Apr
RX Application: 211541

Drug Name

DAPAGLIFLOZIN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2026-04-06

211541 / 1

Active Ingredient

DAPAGLIFLOZIN

Application Number

211541

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211541

Drug Name

DAPAGLIFLOZIN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-04-06

211541 / 2

Active Ingredient

DAPAGLIFLOZIN

Application Number

211541

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211583

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG;1GM

Approval Date

2026-04-06

211583 / 1

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211583

Product Number

1

Dosage Form

-

Strength

2.5MG;1GM

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211583

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG;500MG

Approval Date

2026-04-06

211583 / 2

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211583

Product Number

2

Dosage Form

-

Strength

5MG;500MG

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211583

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

5MG;1GM

Approval Date

2026-04-06

211583 / 3

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211583

Product Number

3

Dosage Form

-

Strength

5MG;1GM

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211583

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

10MG;500MG

Approval Date

2026-04-06

211583 / 4

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211583

Product Number

4

Dosage Form

-

Strength

10MG;500MG

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211583

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

10MG;1GM

Approval Date

2026-04-06

211583 / 5

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211583

Product Number

5

Dosage Form

-

Strength

10MG;1GM

Approval Date

2026-04-06

Regulatory Status

RX

2016
25 Mar
RX Application: 91039

Drug Name

DAPTOMYCIN

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2016-03-25

91039 / 1

Active Ingredient

DAPTOMYCIN

Application Number

91039

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2016-03-25

Regulatory Status

RX

2017
21 Nov
Discontinued Application: 202118

Drug Name

DARUNAVIR

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2017-11-21

202118 / 1

Active Ingredient

DARUNAVIR

Application Number

202118

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2017-11-21

Regulatory Status

Discontinued

-
Unclassified Application: 202118

Drug Name

DARUNAVIR

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

-

202118 / 2

Active Ingredient

DARUNAVIR

Application Number

202118

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 202118

Drug Name

DARUNAVIR

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

-

202118 / 3

Active Ingredient

DARUNAVIR

Application Number

202118

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 202118

Drug Name

DARUNAVIR

Product Number

4

Dosage Form

-

Strength

600MG

Approval Date

-

202118 / 4

Active Ingredient

DARUNAVIR

Application Number

202118

Product Number

4

Dosage Form

-

Strength

600MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 206555

Drug Name

DARUNAVIR

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

-

206555 / 1

Active Ingredient

DARUNAVIR

Application Number

206555

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

-

Regulatory Status

Unclassified

2025
27 Aug
RX Application: 211094

Drug Name

DASATINIB

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2025-08-27

211094 / 1

Active Ingredient

DASATINIB

Application Number

211094

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2025-08-27

Regulatory Status

RX

2025
27 Aug
RX Application: 211094

Drug Name

DASATINIB

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2025-08-27

211094 / 2

Active Ingredient

DASATINIB

Application Number

211094

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2025-08-27

Regulatory Status

RX

2025
27 Aug
RX Application: 211094

Drug Name

DASATINIB

Product Number

3

Dosage Form

-

Strength

70MG

Approval Date

2025-08-27

211094 / 3

Active Ingredient

DASATINIB

Application Number

211094

Product Number

3

Dosage Form

-

Strength

70MG

Approval Date

2025-08-27

Regulatory Status

RX

2025
27 Aug
RX Application: 211094

Drug Name

DASATINIB

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2025-08-27

211094 / 4

Active Ingredient

DASATINIB

Application Number

211094

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2025-08-27

Regulatory Status

RX

2025
27 Aug
RX Application: 211094

Drug Name

DASATINIB

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

2025-08-27

211094 / 5

Active Ingredient

DASATINIB

Application Number

211094

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

2025-08-27

Regulatory Status

RX

2025
27 Aug
RX Application: 211094

Drug Name

DASATINIB

Product Number

6

Dosage Form

-

Strength

140MG

Approval Date

2025-08-27

211094 / 6

Active Ingredient

DASATINIB

Application Number

211094

Product Number

6

Dosage Form

-

Strength

140MG

Approval Date

2025-08-27

Regulatory Status

RX

2022
23 Sep
RX Application: 207124

Drug Name

DEFERASIROX

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2022-09-23

207124 / 1

Active Ingredient

DEFERASIROX

Application Number

207124

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2022-09-23

Regulatory Status

RX

2022
23 Sep
RX Application: 207124

Drug Name

DEFERASIROX

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2022-09-23

207124 / 2

Active Ingredient

DEFERASIROX

Application Number

207124

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2022-09-23

Regulatory Status

RX

2022
23 Sep
RX Application: 207124

Drug Name

DEFERASIROX

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2022-09-23

207124 / 3

Active Ingredient

DEFERASIROX

Application Number

207124

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2022-09-23

Regulatory Status

RX

2019
25 Nov
Discontinued Application: 209223

Drug Name

DEFERASIROX

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2019-11-25

209223 / 1

Active Ingredient

DEFERASIROX

Application Number

209223

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2019-11-25

Regulatory Status

Discontinued

2019
25 Nov
Discontinued Application: 209223

Drug Name

DEFERASIROX

Product Number

2

Dosage Form

-

Strength

360MG

Approval Date

2019-11-25

209223 / 2

Active Ingredient

DEFERASIROX

Application Number

209223

Product Number

2

Dosage Form

-

Strength

360MG

Approval Date

2019-11-25

Regulatory Status

Discontinued

2020
24 Apr
Discontinued Application: 209223

Drug Name

DEFERASIROX

Product Number

3

Dosage Form

-

Strength

180MG

Approval Date

2020-04-24

209223 / 3

Active Ingredient

DEFERASIROX

Application Number

209223

Product Number

3

Dosage Form

-

Strength

180MG

Approval Date

2020-04-24

Regulatory Status

Discontinued

2021
19 Nov
Discontinued Application: 214180

Drug Name

DEFERASIROX

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2021-11-19

214180 / 1

Active Ingredient

DEFERASIROX

Application Number

214180

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2021-11-19

Regulatory Status

Discontinued

2021
19 Nov
Discontinued Application: 214180

Drug Name

DEFERASIROX

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2021-11-19

214180 / 2

Active Ingredient

DEFERASIROX

Application Number

214180

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2021-11-19

Regulatory Status

Discontinued

2021
19 Nov
Discontinued Application: 214180

Drug Name

DEFERASIROX

Product Number

3

Dosage Form

-

Strength

360MG

Approval Date

2021-11-19

214180 / 3

Active Ingredient

DEFERASIROX

Application Number

214180

Product Number

3

Dosage Form

-

Strength

360MG

Approval Date

2021-11-19

Regulatory Status

Discontinued

2013
11 Oct
Discontinued Application: 205208

Drug Name

DESVENLAFAXINE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2013-10-11

205208 / 1

Active Ingredient

DESVENLAFAXINE FUMARATE

Application Number

205208

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2013-10-11

Regulatory Status

Discontinued

2013
11 Oct
Discontinued Application: 205208

Drug Name

DESVENLAFAXINE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2013-10-11

205208 / 2

Active Ingredient

DESVENLAFAXINE FUMARATE

Application Number

205208

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2013-10-11

Regulatory Status

Discontinued

2017
28 Nov
RX Application: 205272

Drug Name

DEXMEDETOMIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

Approval Date

2017-11-28

205272 / 1

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

205272

Product Number

1

Dosage Form

-

Strength

EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

Approval Date

2017-11-28

Regulatory Status

RX

2007
29 Jan
Discontinued Application: 77107

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-01-29

77107 / 1

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

77107

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-01-29

Regulatory Status

Discontinued

2007
29 Jan
Discontinued Application: 77107

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-01-29

77107 / 2

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

77107

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-01-29

Regulatory Status

Discontinued

2007
29 Jan
Discontinued Application: 77107

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

2.5MG

Approval Date

2007-01-29

77107 / 3

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

77107

Product Number

3

Dosage Form

-

Strength

2.5MG

Approval Date

2007-01-29

Regulatory Status

Discontinued

2013
19 Nov
RX Application: 78908

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2013-11-19

78908 / 1

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

78908

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2013-11-19

Regulatory Status

RX

2013
19 Nov
RX Application: 78908

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2013-11-19

78908 / 2

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

78908

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2013-11-19

Regulatory Status

RX

2013
19 Nov
RX Application: 78908

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2013-11-19

78908 / 3

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

78908

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2013-11-19

Regulatory Status

RX

2014
19 May
RX Application: 78908

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2014-05-19

78908 / 4

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

78908

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2014-05-19

Regulatory Status

RX

2017
05 Jul
RX Application: 202731

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2017-07-05

202731 / 1

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

202731

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2017-07-05

Regulatory Status

RX

2013
19 Nov
RX Application: 202731

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2013-11-19

202731 / 2

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

202731

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2013-11-19

Regulatory Status

RX

2014
19 May
RX Application: 202731

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2014-05-19

202731 / 3

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

202731

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2014-05-19

Regulatory Status

RX

2017
05 Jul
RX Application: 202731

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

35MG

Approval Date

2017-07-05

202731 / 4

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

202731

Product Number

4

Dosage Form

-

Strength

35MG

Approval Date

2017-07-05

Regulatory Status

RX

-
Unclassified Application: 202731

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

-

202731 / 5

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

202731

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

-

Regulatory Status

Unclassified

2003
30 Sep
Discontinued Application: 40472

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2003-09-30

40472 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40472

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2003-09-30

Regulatory Status

Discontinued

2003
30 Sep
Discontinued Application: 40472

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

2

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2003-09-30

40472 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40472

Product Number

2

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2003-09-30

Regulatory Status

Discontinued

2003
30 Sep
Discontinued Application: 40472

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

3

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2003-09-30

40472 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40472

Product Number

3

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2003-09-30

Regulatory Status

Discontinued

2003
30 Sep
Discontinued Application: 40472

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

4

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2003-09-30

40472 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40472

Product Number

4

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2003-09-30

Regulatory Status

Discontinued

2022
31 Jan
RX Application: 210876

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

1

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG

Approval Date

2022-01-31

210876 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

210876

Product Number

1

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG

Approval Date

2022-01-31

Regulatory Status

RX

2022
31 Jan
RX Application: 210876

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

2

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2022-01-31

210876 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

210876

Product Number

2

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2022-01-31

Regulatory Status

RX

2022
31 Jan
RX Application: 210876

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

3

Dosage Form

-

Strength

9.375MG;9.375MG;9.375MG;9.375MG

Approval Date

2022-01-31

210876 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

210876

Product Number

3

Dosage Form

-

Strength

9.375MG;9.375MG;9.375MG;9.375MG

Approval Date

2022-01-31

Regulatory Status

RX

2022
31 Jan
RX Application: 210876

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

4

Dosage Form

-

Strength

12.5MG;12.5MG;12.5MG;12.5MG

Approval Date

2022-01-31

210876 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

210876

Product Number

4

Dosage Form

-

Strength

12.5MG;12.5MG;12.5MG;12.5MG

Approval Date

2022-01-31

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 8943

Drug Name

DIAMOX

Product Number

1

Dosage Form

-

Strength

125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

8943 / 1

Active Ingredient

ACETAZOLAMIDE

Application Number

8943

Product Number

1

Dosage Form

-

Strength

125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8943

Drug Name

DIAMOX

Product Number

2

Dosage Form

-

Strength

250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

8943 / 2

Active Ingredient

ACETAZOLAMIDE

Application Number

8943

Product Number

2

Dosage Form

-

Strength

250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9388

Drug Name

DIAMOX

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

9388 / 1

Active Ingredient

ACETAZOLAMIDE SODIUM

Application Number

9388

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12945

Drug Name

DIAMOX

Product Number

1

Dosage Form

-

Strength

500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

12945 / 1

Active Ingredient

ACETAZOLAMIDE

Application Number

12945

Product Number

1

Dosage Form

-

Strength

500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985
01 Nov
Discontinued Application: 70153

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1985-11-01

70153 / 1

Active Ingredient

DIAZEPAM

Application Number

70153

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1985-11-01

Regulatory Status

Discontinued

1997
25 Jun
Discontinued Application: 74459

Drug Name

DICLOFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1997-06-25

74459 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

74459

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1997-06-25

Regulatory Status

Discontinued

1997
25 Jun
Discontinued Application: 74459

Drug Name

DICLOFENAC SODIUM

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1997-06-25

74459 / 2

Active Ingredient

DICLOFENAC SODIUM

Application Number

74459

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1997-06-25

Regulatory Status

Discontinued

1997
25 Jun
Discontinued Application: 74459

Drug Name

DICLOFENAC SODIUM

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1997-06-25

74459 / 3

Active Ingredient

DICLOFENAC SODIUM

Application Number

74459

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1997-06-25

Regulatory Status

Discontinued

1982
03 Jun
RX Application: 62286

Drug Name

DICLOXACILLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-06-03

62286 / 1

Active Ingredient

DICLOXACILLIN SODIUM

Application Number

62286

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-06-03

Regulatory Status

RX

1982
03 Jun
RX Application: 62286

Drug Name

DICLOXACILLIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-06-03

62286 / 2

Active Ingredient

DICLOXACILLIN SODIUM

Application Number

62286

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-06-03

Regulatory Status

RX

1992
05 Nov
Discontinued Application: 74067

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1992-11-05

74067 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74067

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1992-11-05

Regulatory Status

Discontinued

1992
05 Nov
Discontinued Application: 74067

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

1992-11-05

74067 / 2

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74067

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

1992-11-05

Regulatory Status

Discontinued

1992
05 Nov
Discontinued Application: 74067

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

90MG

Approval Date

1992-11-05

74067 / 3

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74067

Product Number

3

Dosage Form

-

Strength

90MG

Approval Date

1992-11-05

Regulatory Status

Discontinued

1992
05 Nov
Discontinued Application: 74067

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

120MG

Approval Date

1992-11-05

74067 / 4

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74067

Product Number

4

Dosage Form

-

Strength

120MG

Approval Date

1992-11-05

Regulatory Status

Discontinued

2020
17 Nov
Discontinued Application: 211505

Drug Name

DIVALPROEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2020-11-17

211505 / 1

Active Ingredient

DIVALPROEX SODIUM

Application Number

211505

Product Number

1

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2020-11-17

Regulatory Status

Discontinued

2015
16 Sep
Discontinued Application: 203877

Drug Name

DOCETAXEL

Product Number

1

Dosage Form

-

Strength

20MG/ML (20MG/ML)

Approval Date

2015-09-16

203877 / 1

Active Ingredient

DOCETAXEL

Application Number

203877

Product Number

1

Dosage Form

-

Strength

20MG/ML (20MG/ML)

Approval Date

2015-09-16

Regulatory Status

Discontinued

2015
16 Sep
Discontinued Application: 203877

Drug Name

DOCETAXEL

Product Number

2

Dosage Form

-

Strength

80MG/4ML (20MG/ML)

Approval Date

2015-09-16

203877 / 2

Active Ingredient

DOCETAXEL

Application Number

203877

Product Number

2

Dosage Form

-

Strength

80MG/4ML (20MG/ML)

Approval Date

2015-09-16

Regulatory Status

Discontinued

2022
15 Apr
Discontinued Application: 210018

Drug Name

DOFETILIDE

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2022-04-15

210018 / 1

Active Ingredient

DOFETILIDE

Application Number

210018

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2022-04-15

Regulatory Status

Discontinued

2022
15 Apr
Discontinued Application: 210018

Drug Name

DOFETILIDE

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2022-04-15

210018 / 2

Active Ingredient

DOFETILIDE

Application Number

210018

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2022-04-15

Regulatory Status

Discontinued

2022
15 Apr
Discontinued Application: 210018

Drug Name

DOFETILIDE

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2022-04-15

210018 / 3

Active Ingredient

DOFETILIDE

Application Number

210018

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2022-04-15

Regulatory Status

Discontinued

2008
04 Dec
Discontinued Application: 78756

Drug Name

DORZOLAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE

Approval Date

2008-12-04

78756 / 1

Active Ingredient

DORZOLAMIDE HYDROCHLORIDE

Application Number

78756

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE

Approval Date

2008-12-04

Regulatory Status

Discontinued

2009
28 Sep
Discontinued Application: 78704

Drug Name

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2009-09-28

78704 / 1

Active Ingredient

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

Application Number

78704

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2009-09-28

Regulatory Status

Discontinued

1987
09 Nov
Discontinued Application: 71609

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1987-11-09

71609 / 1

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

71609

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1987-11-09

Regulatory Status

Discontinued

2023
17 Feb
RX Application: 215408

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2023-02-17

215408 / 1

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

215408

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2023-02-17

Regulatory Status

RX

1995
28 Jul
Discontinued Application: 64140

Drug Name

DOXORUBICIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1995-07-28

64140 / 1

Active Ingredient

DOXORUBICIN HYDROCHLORIDE

Application Number

64140

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1995-07-28

Regulatory Status

Discontinued

1995
28 Jul
Discontinued Application: 64140

Drug Name

DOXORUBICIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

200MG/100ML

Approval Date

1995-07-28

64140 / 2

Active Ingredient

DOXORUBICIN HYDROCHLORIDE

Application Number

64140

Product Number

2

Dosage Form

-

Strength

200MG/100ML

Approval Date

1995-07-28

Regulatory Status

Discontinued

2021
18 Feb
Discontinued Application: 213162

Drug Name

DROXIDOPA

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2021-02-18

213162 / 1

Active Ingredient

DROXIDOPA

Application Number

213162

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2021-02-18

Regulatory Status

Discontinued

2021
18 Feb
Discontinued Application: 213162

Drug Name

DROXIDOPA

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2021-02-18

213162 / 2

Active Ingredient

DROXIDOPA

Application Number

213162

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2021-02-18

Regulatory Status

Discontinued

2021
18 Feb
Discontinued Application: 213162

Drug Name

DROXIDOPA

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2021-02-18

213162 / 3

Active Ingredient

DROXIDOPA

Application Number

213162

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2021-02-18

Regulatory Status

Discontinued

2013
11 Dec
Discontinued Application: 90783

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2013-12-11

90783 / 1

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

90783

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2013-12-11

Regulatory Status

Discontinued

2013
11 Dec
Discontinued Application: 90783

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2013-12-11

90783 / 2

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

90783

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2013-12-11

Regulatory Status

Discontinued

2013
11 Dec
Discontinued Application: 90783

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2013-12-11

90783 / 3

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

90783

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2013-12-11

Regulatory Status

Discontinued

-
Unclassified Application: 91175

Drug Name

EFAVIRENZ

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

-

91175 / 1

Active Ingredient

EFAVIRENZ

Application Number

91175

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

-

Regulatory Status

Unclassified

2018
09 Nov
RX Application: 91215

Drug Name

EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE

Product Number

1

Dosage Form

-

Strength

600MG;200MG;300MG

Approval Date

2018-11-09

91215 / 1

Active Ingredient

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Application Number

91215

Product Number

1

Dosage Form

-

Strength

600MG;200MG;300MG

Approval Date

2018-11-09

Regulatory Status

RX

2020
16 Dec
RX Application: 211827

Drug Name

EFINACONAZOLE

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2020-12-16

211827 / 1

Active Ingredient

EFINACONAZOLE

Application Number

211827

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2020-12-16

Regulatory Status

RX

2017
27 Jun
RX Application: 202040

Drug Name

ELETRIPTAN HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2017-06-27

202040 / 1

Active Ingredient

ELETRIPTAN HYDROBROMIDE

Application Number

202040

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2017-06-27

Regulatory Status

RX

2017
27 Jun
RX Application: 202040

Drug Name

ELETRIPTAN HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2017-06-27

202040 / 2

Active Ingredient

ELETRIPTAN HYDROBROMIDE

Application Number

202040

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2017-06-27

Regulatory Status

RX

2021
27 Dec
Discontinued Application: 212474

Drug Name

ELIGLUSTAT TARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 84MG BASE

Approval Date

2021-12-27

212474 / 1

Active Ingredient

ELIGLUSTAT TARTRATE

Application Number

212474

Product Number

1

Dosage Form

-

Strength

EQ 84MG BASE

Approval Date

2021-12-27

Regulatory Status

Discontinued

2026
13 Jul
RX Application: 209938

Drug Name

ELTROMBOPAG OLAMINE

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG ACID

Approval Date

2026-07-13

209938 / 1

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

209938

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG ACID

Approval Date

2026-07-13

Regulatory Status

RX

2026
13 Jul
RX Application: 209938

Drug Name

ELTROMBOPAG OLAMINE

Product Number

2

Dosage Form

-

Strength

EQ 25MG ACID

Approval Date

2026-07-13

209938 / 2

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

209938

Product Number

2

Dosage Form

-

Strength

EQ 25MG ACID

Approval Date

2026-07-13

Regulatory Status

RX

2026
13 Jul
RX Application: 209938

Drug Name

ELTROMBOPAG OLAMINE

Product Number

3

Dosage Form

-

Strength

EQ 75MG ACID

Approval Date

2026-07-13

209938 / 3

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

209938

Product Number

3

Dosage Form

-

Strength

EQ 75MG ACID

Approval Date

2026-07-13

Regulatory Status

RX

1992
30 Dec
Discontinued Application: 19941

Drug Name

EMLA

Product Number

1

Dosage Form

-

Strength

2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-12-30

19941 / 1

Active Ingredient

LIDOCAINE; PRILOCAINE

Application Number

19941

Product Number

1

Dosage Form

-

Strength

2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-12-30

Regulatory Status

Discontinued

2017
08 Jun
RX Application: 90894

Drug Name

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Product Number

1

Dosage Form

-

Strength

200MG;300MG

Approval Date

2017-06-08

90894 / 1

Active Ingredient

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Application Number

90894

Product Number

1

Dosage Form

-

Strength

200MG;300MG

Approval Date

2017-06-08

Regulatory Status

RX

2014
26 Aug
Discontinued Application: 202122

Drug Name

ENTECAVIR

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2014-08-26

202122 / 1

Active Ingredient

ENTECAVIR

Application Number

202122

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2014-08-26

Regulatory Status

Discontinued

2014
26 Aug
Discontinued Application: 202122

Drug Name

ENTECAVIR

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2014-08-26

202122 / 2

Active Ingredient

ENTECAVIR

Application Number

202122

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2014-08-26

Regulatory Status

Discontinued

2018
16 Aug
RX Application: 90589

Drug Name

EPINEPHRINE (AUTOINJECTOR)

Product Number

1

Dosage Form

-

Strength

0.3MG/DELIVERY

Approval Date

2018-08-16

90589 / 1

Active Ingredient

EPINEPHRINE

Application Number

90589

Product Number

1

Dosage Form

-

Strength

0.3MG/DELIVERY

Approval Date

2018-08-16

Regulatory Status

RX

2018
16 Aug
RX Application: 90589

Drug Name

EPINEPHRINE (AUTOINJECTOR)

Product Number

2

Dosage Form

-

Strength

0.15MG/DELIVERY

Approval Date

2018-08-16

90589 / 2

Active Ingredient

EPINEPHRINE

Application Number

90589

Product Number

2

Dosage Form

-

Strength

0.15MG/DELIVERY

Approval Date

2018-08-16

Regulatory Status

RX

2015
12 Jun
RX Application: 90854

Drug Name

EPTIFIBATIDE

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2015-06-12

90854 / 1

Active Ingredient

EPTIFIBATIDE

Application Number

90854

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2015-06-12

Regulatory Status

RX

2015
05 Jun
Discontinued Application: 91555

Drug Name

EPTIFIBATIDE

Product Number

1

Dosage Form

-

Strength

75MG/100ML

Approval Date

2015-06-05

91555 / 1

Active Ingredient

EPTIFIBATIDE

Application Number

91555

Product Number

1

Dosage Form

-

Strength

75MG/100ML

Approval Date

2015-06-05

Regulatory Status

Discontinued

2020
09 Nov
RX Application: 91059

Drug Name

ERLOTINIB HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2020-11-09

91059 / 1

Active Ingredient

ERLOTINIB HYDROCHLORIDE

Application Number

91059

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2020-11-09

Regulatory Status

RX

2015
28 Aug
RX Application: 91059

Drug Name

ERLOTINIB HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2015-08-28

91059 / 2

Active Ingredient

ERLOTINIB HYDROCHLORIDE

Application Number

91059

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2015-08-28

Regulatory Status

RX

2015
28 Aug
RX Application: 91059

Drug Name

ERLOTINIB HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2015-08-28

91059 / 3

Active Ingredient

ERLOTINIB HYDROCHLORIDE

Application Number

91059

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2015-08-28

Regulatory Status

RX

2021
11 Feb
RX Application: 214549

Drug Name

ERYTHROMYCIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2021-02-11

214549 / 1

Active Ingredient

ERYTHROMYCIN

Application Number

214549

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2021-02-11

Regulatory Status

RX

2021
11 Feb
RX Application: 214549

Drug Name

ERYTHROMYCIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2021-02-11

214549 / 2

Active Ingredient

ERYTHROMYCIN

Application Number

214549

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2021-02-11

Regulatory Status

RX

2012
14 Mar
Discontinued Application: 76765

Drug Name

ESCITALOPRAM OXALATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-03-14

76765 / 1

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

76765

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-03-14

Regulatory Status

Discontinued

2012
14 Mar
Discontinued Application: 76765

Drug Name

ESCITALOPRAM OXALATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-03-14

76765 / 2

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

76765

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-03-14

Regulatory Status

Discontinued

2012
14 Mar
Discontinued Application: 76765

Drug Name

ESCITALOPRAM OXALATE

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-03-14

76765 / 3

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

76765

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-03-14

Regulatory Status

Discontinued

-
Unclassified Application: 77412

Drug Name

ESCITALOPRAM OXALATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

-

77412 / 1

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

77412

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 77412

Drug Name

ESCITALOPRAM OXALATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

77412 / 2

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

77412

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 77412

Drug Name

ESCITALOPRAM OXALATE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

-

77412 / 3

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

77412

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

-

Regulatory Status

Unclassified

2017
21 Jul
RX Application: 206388

Drug Name

ESTRADIOL

Product Number

1

Dosage Form

-

Strength

10MCG

Approval Date

2017-07-21

206388 / 1

Active Ingredient

ESTRADIOL

Application Number

206388

Product Number

1

Dosage Form

-

Strength

10MCG

Approval Date

2017-07-21

Regulatory Status

RX

2018
30 Mar
RX Application: 210488

Drug Name

ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

2018-03-30

210488 / 1

Active Ingredient

ESTRADIOL

Application Number

210488

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

2018-03-30

Regulatory Status

RX

2025
08 Dec
RX Application: 214137

Drug Name

ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.004MG

Approval Date

2025-12-08

214137 / 1

Active Ingredient

ESTRADIOL

Application Number

214137

Product Number

1

Dosage Form

-

Strength

0.004MG

Approval Date

2025-12-08

Regulatory Status

RX

2025
08 Dec
RX Application: 214137

Drug Name

ESTRADIOL

Product Number

2

Dosage Form

-

Strength

0.01MG

Approval Date

2025-12-08

214137 / 2

Active Ingredient

ESTRADIOL

Application Number

214137

Product Number

2

Dosage Form

-

Strength

0.01MG

Approval Date

2025-12-08

Regulatory Status

RX

2012
08 Mar
Discontinued Application: 200747

Drug Name

ESTRADIOL AND NORETHINDRONE ACETATE

Product Number

1

Dosage Form

-

Strength

0.5MG;0.1MG

Approval Date

2012-03-08

200747 / 1

Active Ingredient

ESTRADIOL; NORETHINDRONE ACETATE

Application Number

200747

Product Number

1

Dosage Form

-

Strength

0.5MG;0.1MG

Approval Date

2012-03-08

Regulatory Status

Discontinued

2021
13 Jan
RX Application: 204305

Drug Name

ETHINYL ESTRADIOL; ETONOGESTREL

Product Number

1

Dosage Form

-

Strength

0.015MG/24HR;0.12MG/24HR

Approval Date

2021-01-13

204305 / 1

Active Ingredient

ETHINYL ESTRADIOL; ETONOGESTREL

Application Number

204305

Product Number

1

Dosage Form

-

Strength

0.015MG/24HR;0.12MG/24HR

Approval Date

2021-01-13

Regulatory Status

RX

1993
30 Jul
Discontinued Application: 81306

Drug Name

ETHOSUXIMIDE

Product Number

1

Dosage Form

-

Strength

250MG/5ML

Approval Date

1993-07-30

81306 / 1

Active Ingredient

ETHOSUXIMIDE

Application Number

81306

Product Number

1

Dosage Form

-

Strength

250MG/5ML

Approval Date

1993-07-30

Regulatory Status

Discontinued

1994
10 Feb
Discontinued Application: 74284

Drug Name

ETOPOSIDE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1994-02-10

74284 / 1

Active Ingredient

ETOPOSIDE

Application Number

74284

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1994-02-10

Regulatory Status

Discontinued

1993
28 May
Discontinued Application: 73497

Drug Name

EVALOSE

Product Number

1

Dosage Form

-

Strength

10GM/15ML

Approval Date

1993-05-28

73497 / 1

Active Ingredient

LACTULOSE

Application Number

73497

Product Number

1

Dosage Form

-

Strength

10GM/15ML

Approval Date

1993-05-28

Regulatory Status

Discontinued

2019
09 Dec
RX Application: 210050

Drug Name

EVEROLIMUS

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2019-12-09

210050 / 1

Active Ingredient

EVEROLIMUS

Application Number

210050

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2019-12-09

Regulatory Status

RX

2019
09 Dec
RX Application: 210050

Drug Name

EVEROLIMUS

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-12-09

210050 / 2

Active Ingredient

EVEROLIMUS

Application Number

210050

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-12-09

Regulatory Status

RX

2019
09 Dec
RX Application: 210050

Drug Name

EVEROLIMUS

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2019-12-09

210050 / 3

Active Ingredient

EVEROLIMUS

Application Number

210050

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2019-12-09

Regulatory Status

RX

2019
09 Dec
RX Application: 210050

Drug Name

EVEROLIMUS

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2019-12-09

210050 / 4

Active Ingredient

EVEROLIMUS

Application Number

210050

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2019-12-09

Regulatory Status

RX

2017
12 Jun
Discontinued Application: 78724

Drug Name

EZETIMIBE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-06-12

78724 / 1

Active Ingredient

EZETIMIBE

Application Number

78724

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-06-12

Regulatory Status

Discontinued

2007
24 Aug
RX Application: 77487

Drug Name

FAMCICLOVIR

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2007-08-24

77487 / 1

Active Ingredient

FAMCICLOVIR

Application Number

77487

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2007-08-24

Regulatory Status

RX

2007
24 Aug
RX Application: 77487

Drug Name

FAMCICLOVIR

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2007-08-24

77487 / 2

Active Ingredient

FAMCICLOVIR

Application Number

77487

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2007-08-24

Regulatory Status

RX

2007
24 Aug
RX Application: 77487

Drug Name

FAMCICLOVIR

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2007-08-24

77487 / 3

Active Ingredient

FAMCICLOVIR

Application Number

77487

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2007-08-24

Regulatory Status

RX

2026
11 Mar
RX Application: 212563

Drug Name

FERRIC CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 210MG IRON

Approval Date

2026-03-11

212563 / 1

Active Ingredient

FERRIC CITRATE

Application Number

212563

Product Number

1

Dosage Form

-

Strength

EQ 210MG IRON

Approval Date

2026-03-11

Regulatory Status

RX

2020
02 Jul
RX Application: 208008

Drug Name

FINGOLIMOD HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2020-07-02

208008 / 1

Active Ingredient

FINGOLIMOD HYDROCHLORIDE

Application Number

208008

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2020-07-02

Regulatory Status

RX

2021
12 Nov
Discontinued Application: 212152

Drug Name

FINGOLIMOD HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

2021-11-12

212152 / 1

Active Ingredient

FINGOLIMOD HYDROCHLORIDE

Application Number

212152

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

2021-11-12

Regulatory Status

Discontinued

2020
07 Apr
RX Application: 210087

Drug Name

FINZALA

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2020-04-07

210087 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

210087

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2020-04-07

Regulatory Status

RX

1990
28 Sep
Discontinued Application: 72522

Drug Name

FLUOCINONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1990-09-28

72522 / 1

Active Ingredient

FLUOCINONIDE

Application Number

72522

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1990-09-28

Regulatory Status

Discontinued

2000
27 Jan
Discontinued Application: 40333

Drug Name

FLUOROURACIL

Product Number

1

Dosage Form

-

Strength

500MG/10ML (50MG/ML)

Approval Date

2000-01-27

40333 / 1

Active Ingredient

FLUOROURACIL

Application Number

40333

Product Number

1

Dosage Form

-

Strength

500MG/10ML (50MG/ML)

Approval Date

2000-01-27

Regulatory Status

Discontinued

2000
25 Feb
Discontinued Application: 40334

Drug Name

FLUOROURACIL

Product Number

1

Dosage Form

-

Strength

2.5GM/50ML (50MG/ML)

Approval Date

2000-02-25

40334 / 1

Active Ingredient

FLUOROURACIL

Application Number

40334

Product Number

1

Dosage Form

-

Strength

2.5GM/50ML (50MG/ML)

Approval Date

2000-02-25

Regulatory Status

Discontinued

2000
25 Feb
Discontinued Application: 40334

Drug Name

FLUOROURACIL

Product Number

2

Dosage Form

-

Strength

5GM/100ML (50MG/ML)

Approval Date

2000-02-25

40334 / 2

Active Ingredient

FLUOROURACIL

Application Number

40334

Product Number

2

Dosage Form

-

Strength

5GM/100ML (50MG/ML)

Approval Date

2000-02-25

Regulatory Status

Discontinued

2002
29 Jan
RX Application: 76001

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2002-01-29

76001 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

76001

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2002-01-29

Regulatory Status

RX

2002
29 Jan
RX Application: 76001

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2002-01-29

76001 / 2

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

76001

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2002-01-29

Regulatory Status

RX

2018
03 Dec
Discontinued Application: 211051

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2018-12-03

211051 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

211051

Product Number

1

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2018-12-03

Regulatory Status

Discontinued

2021
13 Dec
RX Application: 213948

Drug Name

FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE

Product Number

1

Dosage Form

-

Strength

0.1MG/INH;EQ 0.05MG BASE/INH

Approval Date

2021-12-13

213948 / 1

Active Ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Application Number

213948

Product Number

1

Dosage Form

-

Strength

0.1MG/INH;EQ 0.05MG BASE/INH

Approval Date

2021-12-13

Regulatory Status

RX

2021
13 Dec
RX Application: 213948

Drug Name

FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE

Product Number

2

Dosage Form

-

Strength

0.25MG/INH;EQ 0.05MG BASE/INH

Approval Date

2021-12-13

213948 / 2

Active Ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Application Number

213948

Product Number

2

Dosage Form

-

Strength

0.25MG/INH;EQ 0.05MG BASE/INH

Approval Date

2021-12-13

Regulatory Status

RX

2021
13 Dec
RX Application: 213948

Drug Name

FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE

Product Number

3

Dosage Form

-

Strength

0.5MG/INH;EQ 0.05MG BASE/INH

Approval Date

2021-12-13

213948 / 3

Active Ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Application Number

213948

Product Number

3

Dosage Form

-

Strength

0.5MG/INH;EQ 0.05MG BASE/INH

Approval Date

2021-12-13

Regulatory Status

RX

2012
12 Jun
RX Application: 78407

Drug Name

FLUVASTATIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-06-12

78407 / 1

Active Ingredient

FLUVASTATIN SODIUM

Application Number

78407

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-06-12

Regulatory Status

RX

2012
12 Jun
RX Application: 78407

Drug Name

FLUVASTATIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2012-06-12

78407 / 2

Active Ingredient

FLUVASTATIN SODIUM

Application Number

78407

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2012-06-12

Regulatory Status

RX

2016
27 Jan
RX Application: 79011

Drug Name

FLUVASTATIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2016-01-27

79011 / 1

Active Ingredient

FLUVASTATIN SODIUM

Application Number

79011

Product Number

1

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2016-01-27

Regulatory Status

RX

2021
22 Jun
RX Application: 91141

Drug Name

FORMOTEROL FUMARATE

Product Number

1

Dosage Form

-

Strength

0.02MG/2ML

Approval Date

2021-06-22

91141 / 1

Active Ingredient

FORMOTEROL FUMARATE

Application Number

91141

Product Number

1

Dosage Form

-

Strength

0.02MG/2ML

Approval Date

2021-06-22

Regulatory Status

RX

2019
05 Sep
RX Application: 210064

Drug Name

FOSAPREPITANT DIMEGLUMINE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/VIAL

Approval Date

2019-09-05

210064 / 1

Active Ingredient

FOSAPREPITANT DIMEGLUMINE

Application Number

210064

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/VIAL

Approval Date

2019-09-05

Regulatory Status

RX

2004
08 Oct
Discontinued Application: 75435

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2004-10-08

75435 / 1

Active Ingredient

GABAPENTIN

Application Number

75435

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2004-10-08

Regulatory Status

Discontinued

2004
08 Oct
Discontinued Application: 75435

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2004-10-08

75435 / 2

Active Ingredient

GABAPENTIN

Application Number

75435

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2004-10-08

Regulatory Status

Discontinued

2004
08 Oct
Discontinued Application: 75435

Drug Name

GABAPENTIN

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2004-10-08

75435 / 3

Active Ingredient

GABAPENTIN

Application Number

75435

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2004-10-08

Regulatory Status

Discontinued

2017
10 Mar
Discontinued Application: 205807

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2017-03-10

205807 / 1

Active Ingredient

GABAPENTIN

Application Number

205807

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2017-03-10

Regulatory Status

Discontinued

2017
10 Mar
Discontinued Application: 205807

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2017-03-10

205807 / 2

Active Ingredient

GABAPENTIN

Application Number

205807

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2017-03-10

Regulatory Status

Discontinued

2011
25 Jan
Discontinued Application: 77983

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2011-01-25

77983 / 1

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

77983

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2011-01-25

Regulatory Status

Discontinued

2011
25 Jan
Discontinued Application: 77983

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE/VIAL

Approval Date

2011-01-25

77983 / 2

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

77983

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE/VIAL

Approval Date

2011-01-25

Regulatory Status

Discontinued

2005
28 Oct
RX Application: 77270

Drug Name

GLIPIZIDE AND METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG;250MG

Approval Date

2005-10-28

77270 / 1

Active Ingredient

GLIPIZIDE; METFORMIN HYDROCHLORIDE

Application Number

77270

Product Number

1

Dosage Form

-

Strength

2.5MG;250MG

Approval Date

2005-10-28

Regulatory Status

RX

2005
28 Oct
RX Application: 77270

Drug Name

GLIPIZIDE AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2.5MG;500MG

Approval Date

2005-10-28

77270 / 2

Active Ingredient

GLIPIZIDE; METFORMIN HYDROCHLORIDE

Application Number

77270

Product Number

2

Dosage Form

-

Strength

2.5MG;500MG

Approval Date

2005-10-28

Regulatory Status

RX

2005
28 Oct
RX Application: 77270

Drug Name

GLIPIZIDE AND METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

5MG;500MG

Approval Date

2005-10-28

77270 / 3

Active Ingredient

GLIPIZIDE; METFORMIN HYDROCHLORIDE

Application Number

77270

Product Number

3

Dosage Form

-

Strength

5MG;500MG

Approval Date

2005-10-28

Regulatory Status

RX

2008
03 Jan
Discontinued Application: 77963

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

Approval Date

2008-01-03

77963 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

77963

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

Approval Date

2008-01-03

Regulatory Status

Discontinued

2007
31 Dec
Discontinued Application: 78080

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2007-12-31

78080 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

78080

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2007-12-31

Regulatory Status

Discontinued

2015
02 Jun
RX Application: 201382

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2015-06-02

201382 / 1

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

201382

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2015-06-02

Regulatory Status

RX

2015
02 Jun
RX Application: 201382

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2015-06-02

201382 / 2

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

201382

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2015-06-02

Regulatory Status

RX

2015
02 Jun
RX Application: 201382

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2015-06-02

201382 / 3

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

201382

Product Number

3

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2015-06-02

Regulatory Status

RX

2015
02 Jun
RX Application: 201382

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2015-06-02

201382 / 4

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

201382

Product Number

4

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2015-06-02

Regulatory Status

RX

1998
13 Feb
Discontinued Application: 73249

Drug Name

GYNIX

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1998-02-13

73249 / 1

Active Ingredient

CLOTRIMAZOLE

Application Number

73249

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1998-02-13

Regulatory Status

Discontinued

1988
01 Dec
Discontinued Application: 71617

Drug Name

HALOPERIDOL

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

1988-12-01

71617 / 1

Active Ingredient

HALOPERIDOL LACTATE

Application Number

71617

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

1988-12-01

Regulatory Status

Discontinued

2001
29 Aug
Discontinued Application: 76035

Drug Name

HALOPERIDOL

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2001-08-29

76035 / 1

Active Ingredient

HALOPERIDOL LACTATE

Application Number

76035

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2001-08-29

Regulatory Status

Discontinued

1999
11 May
Discontinued Application: 75393

Drug Name

HALOPERIDOL DECANOATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1999-05-11

75393 / 1

Active Ingredient

HALOPERIDOL DECANOATE

Application Number

75393

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1999-05-11

Regulatory Status

Discontinued

1999
11 May
Discontinued Application: 75393

Drug Name

HALOPERIDOL DECANOATE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

1999-05-11

75393 / 2

Active Ingredient

HALOPERIDOL DECANOATE

Application Number

75393

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

1999-05-11

Regulatory Status

Discontinued

1993
28 May
Discontinued Application: 73504

Drug Name

HEPTALAC

Product Number

1

Dosage Form

-

Strength

10GM/15ML

Approval Date

1993-05-28

73504 / 1

Active Ingredient

LACTULOSE

Application Number

73504

Product Number

1

Dosage Form

-

Strength

10GM/15ML

Approval Date

1993-05-28

Regulatory Status

Discontinued

1994
27 May
Discontinued Application: 74171

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

100MG/60ML

Approval Date

1994-05-27

74171 / 1

Active Ingredient

HYDROCORTISONE

Application Number

74171

Product Number

1

Dosage Form

-

Strength

100MG/60ML

Approval Date

1994-05-27

Regulatory Status

Discontinued

1994
30 Sep
RX Application: 40081

Drug Name

HYDROXYCHLOROQUINE SULFATE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1994-09-30

40081 / 1

Active Ingredient

HYDROXYCHLOROQUINE SULFATE

Application Number

40081

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1994-09-30

Regulatory Status

RX

-
Unclassified Application: 211350

Drug Name

IBRUTINIB

Product Number

1

Dosage Form

-

Strength

140MG

Approval Date

-

211350 / 1

Active Ingredient

IBRUTINIB

Application Number

211350

Product Number

1

Dosage Form

-

Strength

140MG

Approval Date

-

Regulatory Status

Unclassified

2021
29 Oct
Discontinued Application: 211278

Drug Name

IBUPROFEN AND FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

26.6MG;800MG

Approval Date

2021-10-29

211278 / 1

Active Ingredient

FAMOTIDINE; IBUPROFEN

Application Number

211278

Product Number

1

Dosage Form

-

Strength

26.6MG;800MG

Approval Date

2021-10-29

Regulatory Status

Discontinued

2019
15 Jul
RX Application: 210118

Drug Name

ICATIBANT ACETATE

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

2019-07-15

210118 / 1

Active Ingredient

ICATIBANT ACETATE

Application Number

210118

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

2019-07-15

Regulatory Status

RX

2020
11 Sep
RX Application: 209525

Drug Name

ICOSAPENT ETHYL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2020-09-11

209525 / 1

Active Ingredient

ICOSAPENT ETHYL

Application Number

209525

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2020-09-11

Regulatory Status

RX

2020
11 Sep
RX Application: 209525

Drug Name

ICOSAPENT ETHYL

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2020-09-11

209525 / 2

Active Ingredient

ICOSAPENT ETHYL

Application Number

209525

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2020-09-11

Regulatory Status

RX

2002
26 Feb
Discontinued Application: 75874

Drug Name

IFOSFAMIDE/MESNA KIT

Product Number

1

Dosage Form

-

Strength

1GM/20ML;1GM/10ML (50MG/ML;100MG/ML)

Approval Date

2002-02-26

75874 / 1

Active Ingredient

IFOSFAMIDE; MESNA

Application Number

75874

Product Number

1

Dosage Form

-

Strength

1GM/20ML;1GM/10ML (50MG/ML;100MG/ML)

Approval Date

2002-02-26

Regulatory Status

Discontinued

2002
26 Feb
Discontinued Application: 75874

Drug Name

IFOSFAMIDE/MESNA KIT

Product Number

2

Dosage Form

-

Strength

3GM/60ML;1GM/10ML (50MG/ML;100MG/ML)

Approval Date

2002-02-26

75874 / 2

Active Ingredient

IFOSFAMIDE; MESNA

Application Number

75874

Product Number

2

Dosage Form

-

Strength

3GM/60ML;1GM/10ML (50MG/ML;100MG/ML)

Approval Date

2002-02-26

Regulatory Status

Discontinued

2016
04 Aug
RX Application: 204285

Drug Name

IMATINIB MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2016-08-04

204285 / 1

Active Ingredient

IMATINIB MESYLATE

Application Number

204285

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2016-08-04

Regulatory Status

RX

2016
04 Aug
RX Application: 204285

Drug Name

IMATINIB MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2016-08-04

204285 / 2

Active Ingredient

IMATINIB MESYLATE

Application Number

204285

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2016-08-04

Regulatory Status

RX

2000
07 Feb
Discontinued Application: 75313

Drug Name

IPRATROPIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

0.02%

Approval Date

2000-02-07

75313 / 1

Active Ingredient

IPRATROPIUM BROMIDE

Application Number

75313

Product Number

1

Dosage Form

-

Strength

0.02%

Approval Date

2000-02-07

Regulatory Status

Discontinued

2012
30 Mar
RX Application: 77159

Drug Name

IRBESARTAN

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2012-03-30

77159 / 1

Active Ingredient

IRBESARTAN

Application Number

77159

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2012-03-30

Regulatory Status

RX

2012
30 Mar
RX Application: 77159

Drug Name

IRBESARTAN

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2012-03-30

77159 / 2

Active Ingredient

IRBESARTAN

Application Number

77159

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2012-03-30

Regulatory Status

RX

2012
30 Mar
RX Application: 77159

Drug Name

IRBESARTAN

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2012-03-30

77159 / 3

Active Ingredient

IRBESARTAN

Application Number

77159

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2012-03-30

Regulatory Status

RX

2008
26 Nov
RX Application: 90101

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG/25ML (20MG/ML)

Approval Date

2008-11-26

90101 / 1

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

90101

Product Number

1

Dosage Form

-

Strength

500MG/25ML (20MG/ML)

Approval Date

2008-11-26

Regulatory Status

RX

2008
27 Feb
Discontinued Application: 90101

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

40MG/2ML (20MG/ML)

Approval Date

2008-02-27

90101 / 2

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

90101

Product Number

2

Dosage Form

-

Strength

40MG/2ML (20MG/ML)

Approval Date

2008-02-27

Regulatory Status

Discontinued

2008
27 Feb
Discontinued Application: 90101

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2008-02-27

90101 / 3

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

90101

Product Number

3

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2008-02-27

Regulatory Status

Discontinued

2019
13 Sep
RX Application: 210019

Drug Name

IVERMECTIN

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2019-09-13

210019 / 1

Active Ingredient

IVERMECTIN

Application Number

210019

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2019-09-13

Regulatory Status

RX

2022
21 Mar
Discontinued Application: 212485

Drug Name

IVERMECTIN

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2022-03-21

212485 / 1

Active Ingredient

IVERMECTIN

Application Number

212485

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2022-03-21

Regulatory Status

Discontinued

-
Unclassified Application: 204999

Drug Name

LACOSAMIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

204999 / 1

Active Ingredient

LACOSAMIDE

Application Number

204999

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 204999

Drug Name

LACOSAMIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

204999 / 2

Active Ingredient

LACOSAMIDE

Application Number

204999

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 204999

Drug Name

LACOSAMIDE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

-

204999 / 3

Active Ingredient

LACOSAMIDE

Application Number

204999

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 204999

Drug Name

LACOSAMIDE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

-

204999 / 4

Active Ingredient

LACOSAMIDE

Application Number

204999

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 78636

Drug Name

LAMIVUDINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

-

78636 / 1

Active Ingredient

LAMIVUDINE

Application Number

78636

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 78636

Drug Name

LAMIVUDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

-

78636 / 2

Active Ingredient

LAMIVUDINE

Application Number

78636

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

-

Regulatory Status

Unclassified

2009
10 Nov
RX Application: 77255

Drug Name

LANSOPRAZOLE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2009-11-10

77255 / 1

Active Ingredient

LANSOPRAZOLE

Application Number

77255

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2009-11-10

Regulatory Status

RX

2009
10 Nov
RX Application: 77255

Drug Name

LANSOPRAZOLE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2009-11-10

77255 / 2

Active Ingredient

LANSOPRAZOLE

Application Number

77255

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2009-11-10

Regulatory Status

RX

2017
21 Sep
RX Application: 208784

Drug Name

LANSOPRAZOLE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2017-09-21

208784 / 1

Active Ingredient

LANSOPRAZOLE

Application Number

208784

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2017-09-21

Regulatory Status

RX

2017
21 Sep
RX Application: 208784

Drug Name

LANSOPRAZOLE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2017-09-21

208784 / 2

Active Ingredient

LANSOPRAZOLE

Application Number

208784

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2017-09-21

Regulatory Status

RX

2024
16 Aug
RX Application: 217968

Drug Name

LAPATINIB DITOSYLATE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2024-08-16

217968 / 1

Active Ingredient

LAPATINIB DITOSYLATE

Application Number

217968

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2024-08-16

Regulatory Status

RX

2005
13 Sep
Discontinued Application: 77084

Drug Name

LEFLUNOMIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2005-09-13

77084 / 1

Active Ingredient

LEFLUNOMIDE

Application Number

77084

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2005-09-13

Regulatory Status

Discontinued

2005
13 Sep
Discontinued Application: 77084

Drug Name

LEFLUNOMIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2005-09-13

77084 / 2

Active Ingredient

LEFLUNOMIDE

Application Number

77084

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2005-09-13

Regulatory Status

Discontinued

2011
03 Jun
RX Application: 90289

Drug Name

LETROZOLE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2011-06-03

90289 / 1

Active Ingredient

LETROZOLE

Application Number

90289

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2011-06-03

Regulatory Status

RX

1997
12 Jun
Discontinued Application: 40174

Drug Name

LEUCOVORIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 350MG BASE/VIAL

Approval Date

1997-06-12

40174 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

40174

Product Number

1

Dosage Form

-

Strength

EQ 350MG BASE/VIAL

Approval Date

1997-06-12

Regulatory Status

Discontinued

1993
28 Sep
Discontinued Application: 81277

Drug Name

LEUCOVORIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

1993-09-28

81277 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

81277

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

1993-09-28

Regulatory Status

Discontinued

2013
26 Apr
RX Application: 90297

Drug Name

LEVALBUTEROL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.0103% BASE

Approval Date

2013-04-26

90297 / 1

Active Ingredient

LEVALBUTEROL HYDROCHLORIDE

Application Number

90297

Product Number

1

Dosage Form

-

Strength

EQ 0.0103% BASE

Approval Date

2013-04-26

Regulatory Status

RX

2013
26 Apr
RX Application: 90297

Drug Name

LEVALBUTEROL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 0.021% BASE

Approval Date

2013-04-26

90297 / 2

Active Ingredient

LEVALBUTEROL HYDROCHLORIDE

Application Number

90297

Product Number

2

Dosage Form

-

Strength

EQ 0.021% BASE

Approval Date

2013-04-26

Regulatory Status

RX

2013
26 Apr
RX Application: 90297

Drug Name

LEVALBUTEROL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 0.042% BASE

Approval Date

2013-04-26

90297 / 3

Active Ingredient

LEVALBUTEROL HYDROCHLORIDE

Application Number

90297

Product Number

3

Dosage Form

-

Strength

EQ 0.042% BASE

Approval Date

2013-04-26

Regulatory Status

RX

2009
15 Jan
Discontinued Application: 78101

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2009-01-15

78101 / 1

Active Ingredient

LEVETIRACETAM

Application Number

78101

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2009-01-15

Regulatory Status

Discontinued

2009
15 Jan
Discontinued Application: 78101

Drug Name

LEVETIRACETAM

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2009-01-15

78101 / 2

Active Ingredient

LEVETIRACETAM

Application Number

78101

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2009-01-15

Regulatory Status

Discontinued

2009
15 Jan
Discontinued Application: 78101

Drug Name

LEVETIRACETAM

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2009-01-15

78101 / 3

Active Ingredient

LEVETIRACETAM

Application Number

78101

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2009-01-15

Regulatory Status

Discontinued

2009
15 Jan
Discontinued Application: 78101

Drug Name

LEVETIRACETAM

Product Number

4

Dosage Form

-

Strength

1GM

Approval Date

2009-01-15

78101 / 4

Active Ingredient

LEVETIRACETAM

Application Number

78101

Product Number

4

Dosage Form

-

Strength

1GM

Approval Date

2009-01-15

Regulatory Status

Discontinued

2011
12 Sep
Discontinued Application: 91430

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2011-09-12

91430 / 1

Active Ingredient

LEVETIRACETAM

Application Number

91430

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2011-09-12

Regulatory Status

Discontinued

2011
12 Sep
Discontinued Application: 91430

Drug Name

LEVETIRACETAM

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2011-09-12

91430 / 2

Active Ingredient

LEVETIRACETAM

Application Number

91430

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2011-09-12

Regulatory Status

Discontinued

2001
29 Mar
Discontinued Application: 75881

Drug Name

LEVOCARNITINE

Product Number

1

Dosage Form

-

Strength

200MG/ML

Approval Date

2001-03-29

75881 / 1

Active Ingredient

LEVOCARNITINE

Application Number

75881

Product Number

1

Dosage Form

-

Strength

200MG/ML

Approval Date

2001-03-29

Regulatory Status

Discontinued

2011
22 Aug
RX Application: 90199

Drug Name

LEVOCETIRIZINE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-08-22

90199 / 1

Active Ingredient

LEVOCETIRIZINE DIHYDROCHLORIDE

Application Number

90199

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-08-22

Regulatory Status

RX

2018
16 Jan
Discontinued Application: 210256

Drug Name

LIDOCAINE

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2018-01-16

210256 / 1

Active Ingredient

LIDOCAINE

Application Number

210256

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2018-01-16

Regulatory Status

Discontinued

2026
27 May
RX Application: 208433

Drug Name

LINAGLIPTIN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2026-05-27

208433 / 1

Active Ingredient

LINAGLIPTIN

Application Number

208433

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2026-05-27

Regulatory Status

RX

2015
18 May
Discontinued Application: 78061

Drug Name

LINEZOLID

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2015-05-18

78061 / 1

Active Ingredient

LINEZOLID

Application Number

78061

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2015-05-18

Regulatory Status

Discontinued

2016
05 Feb
Discontinued Application: 91210

Drug Name

LINEZOLID

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2016-02-05

91210 / 1

Active Ingredient

LINEZOLID

Application Number

91210

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2016-02-05

Regulatory Status

Discontinued

2012
27 Jun
Discontinued Application: 200222

Drug Name

LINEZOLID

Product Number

1

Dosage Form

-

Strength

600MG/300ML (2MG/ML)

Approval Date

2012-06-27

200222 / 1

Active Ingredient

LINEZOLID

Application Number

200222

Product Number

1

Dosage Form

-

Strength

600MG/300ML (2MG/ML)

Approval Date

2012-06-27

Regulatory Status

Discontinued

2018
26 Oct
RX Application: 211510

Drug Name

LIOTHYRONINE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 0.005MG BASE

Approval Date

2018-10-26

211510 / 1

Active Ingredient

LIOTHYRONINE SODIUM

Application Number

211510

Product Number

1

Dosage Form

-

Strength

EQ 0.005MG BASE

Approval Date

2018-10-26

Regulatory Status

RX

2018
26 Oct
RX Application: 211510

Drug Name

LIOTHYRONINE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 0.025MG BASE

Approval Date

2018-10-26

211510 / 2

Active Ingredient

LIOTHYRONINE SODIUM

Application Number

211510

Product Number

2

Dosage Form

-

Strength

EQ 0.025MG BASE

Approval Date

2018-10-26

Regulatory Status

RX

2018
26 Oct
RX Application: 211510

Drug Name

LIOTHYRONINE SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 0.05MG BASE

Approval Date

2018-10-26

211510 / 3

Active Ingredient

LIOTHYRONINE SODIUM

Application Number

211510

Product Number

3

Dosage Form

-

Strength

EQ 0.05MG BASE

Approval Date

2018-10-26

Regulatory Status

RX

2025
27 Aug
RX Application: 214568

Drug Name

LIRAGLUTIDE

Product Number

1

Dosage Form

-

Strength

18MG/3ML (6MG/ML)

Approval Date

2025-08-27

214568 / 1

Active Ingredient

LIRAGLUTIDE

Application Number

214568

Product Number

1

Dosage Form

-

Strength

18MG/3ML (6MG/ML)

Approval Date

2025-08-27

Regulatory Status

RX

2023
25 Aug
RX Application: 215415

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-08-25

215415 / 1

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

215415

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 215415

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2023-08-25

215415 / 2

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

215415

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 215415

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2023-08-25

215415 / 3

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

215415

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 215415

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2023-08-25

215415 / 4

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

215415

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 215415

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2023-08-25

215415 / 5

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

215415

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 215415

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2023-08-25

215415 / 6

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

215415

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2023-08-25

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 17875

Drug Name

LOESTRIN 21 1.5/30

Product Number

1

Dosage Form

-

Strength

0.03MG;1.5MG

Approval Date

1982-01-01

17875 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

17875

Product Number

1

Dosage Form

-

Strength

0.03MG;1.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17876

Drug Name

LOESTRIN 21 1/20

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17876 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

17876

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

2006
17 Feb
Discontinued Application: 21871

Drug Name

LOESTRIN 24 FE

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2006-02-17

21871 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

21871

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2006-02-17

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17355

Drug Name

LOESTRIN FE 1.5/30

Product Number

1

Dosage Form

-

Strength

0.03MG;1.5MG

Approval Date

1982-01-01

17355 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

17355

Product Number

1

Dosage Form

-

Strength

0.03MG;1.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17354

Drug Name

LOESTRIN FE 1/20

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17354 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

17354

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

2017
13 Feb
RX Application: 207952

Drug Name

LOGILIA

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2017-02-13

207952 / 1

Active Ingredient

ULIPRISTAL ACETATE

Application Number

207952

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2017-02-13

Regulatory Status

RX

2010
06 Apr
RX Application: 77157

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;50MG

Approval Date

2010-04-06

77157 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

77157

Product Number

1

Dosage Form

-

Strength

12.5MG;50MG

Approval Date

2010-04-06

Regulatory Status

RX

2010
06 Apr
RX Application: 77157

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;100MG

Approval Date

2010-04-06

77157 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

77157

Product Number

2

Dosage Form

-

Strength

12.5MG;100MG

Approval Date

2010-04-06

Regulatory Status

RX

2010
06 Apr
RX Application: 77157

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;100MG

Approval Date

2010-04-06

77157 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

77157

Product Number

3

Dosage Form

-

Strength

25MG;100MG

Approval Date

2010-04-06

Regulatory Status

RX

2008
24 Oct
RX Application: 22262

Drug Name

LOSEASONIQUE

Product Number

1

Dosage Form

-

Strength

0.02MG,0.1MG;0.01MG,N/A

Approval Date

2008-10-24

22262 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

22262

Product Number

1

Dosage Form

-

Strength

0.02MG,0.1MG;0.01MG,N/A

Approval Date

2008-10-24

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 17525

Drug Name

LOXITANE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17525 / 1

Active Ingredient

LOXAPINE SUCCINATE

Application Number

17525

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17525

Drug Name

LOXITANE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17525 / 2

Active Ingredient

LOXAPINE SUCCINATE

Application Number

17525

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17525

Drug Name

LOXITANE

Product Number

3

Dosage Form

-

Strength

EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17525 / 3

Active Ingredient

LOXAPINE SUCCINATE

Application Number

17525

Product Number

3

Dosage Form

-

Strength

EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17525

Drug Name

LOXITANE

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17525 / 4

Active Ingredient

LOXAPINE SUCCINATE

Application Number

17525

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17525

Drug Name

LOXITANE

Product Number

6

Dosage Form

-

Strength

EQ 10MG BASE **Federal Register determination that product was discontinued or withdrawn for s or e reasons**

Approval Date

1982-01-01

17525 / 6

Active Ingredient

LOXAPINE SUCCINATE

Application Number

17525

Product Number

6

Dosage Form

-

Strength

EQ 10MG BASE **Federal Register determination that product was discontinued or withdrawn for s or e reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17525

Drug Name

LOXITANE

Product Number

7

Dosage Form

-

Strength

EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17525 / 7

Active Ingredient

LOXAPINE SUCCINATE

Application Number

17525

Product Number

7

Dosage Form

-

Strength

EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17525

Drug Name

LOXITANE

Product Number

8

Dosage Form

-

Strength

EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17525 / 8

Active Ingredient

LOXAPINE SUCCINATE

Application Number

17525

Product Number

8

Dosage Form

-

Strength

EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17658

Drug Name

LOXITANE C

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/ML

Approval Date

1982-01-01

17658 / 1

Active Ingredient

LOXAPINE HYDROCHLORIDE

Application Number

17658

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2022
18 Jan
RX Application: 209920

Drug Name

LUBIPROSTONE

Product Number

1

Dosage Form

-

Strength

8MCG

Approval Date

2022-01-18

209920 / 1

Active Ingredient

LUBIPROSTONE

Application Number

209920

Product Number

1

Dosage Form

-

Strength

8MCG

Approval Date

2022-01-18

Regulatory Status

RX

2022
18 Jan
RX Application: 209920

Drug Name

LUBIPROSTONE

Product Number

2

Dosage Form

-

Strength

24MCG

Approval Date

2022-01-18

209920 / 2

Active Ingredient

LUBIPROSTONE

Application Number

209920

Product Number

2

Dosage Form

-

Strength

24MCG

Approval Date

2022-01-18

Regulatory Status

RX

2019
17 May
Discontinued Application: 208060

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2019-05-17

208060 / 1

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208060

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2019-05-17

Regulatory Status

Discontinued

2019
17 May
Discontinued Application: 208060

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2019-05-17

208060 / 2

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208060

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2019-05-17

Regulatory Status

Discontinued

2019
17 May
Discontinued Application: 208060

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2019-05-17

208060 / 3

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208060

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2019-05-17

Regulatory Status

Discontinued

2019
17 May
Discontinued Application: 208060

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2019-05-17

208060 / 4

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208060

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2019-05-17

Regulatory Status

Discontinued

2019
17 May
Discontinued Application: 208060

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

120MG

Approval Date

2019-05-17

208060 / 5

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208060

Product Number

5

Dosage Form

-

Strength

120MG

Approval Date

2019-05-17

Regulatory Status

Discontinued

2026
08 Jun
RX Application: 211187

Drug Name

MACITENTAN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2026-06-08

211187 / 1

Active Ingredient

MACITENTAN

Application Number

211187

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2026-06-08

Regulatory Status

RX

2004
27 Oct
Discontinued Application: 76552

Drug Name

MEDROXYPROGESTERONE ACETATE

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

2004-10-27

76552 / 1

Active Ingredient

MEDROXYPROGESTERONE ACETATE

Application Number

76552

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

2004-10-27

Regulatory Status

Discontinued

2003
05 May
Discontinued Application: 75681

Drug Name

MEGESTROL ACETATE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2003-05-05

75681 / 1

Active Ingredient

MEGESTROL ACETATE

Application Number

75681

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2003-05-05

Regulatory Status

Discontinued

2011
25 Oct
Discontinued Application: 90052

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-10-25

90052 / 1

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

90052

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-10-25

Regulatory Status

Discontinued

2011
25 Oct
Discontinued Application: 90052

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-10-25

90052 / 2

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

90052

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-10-25

Regulatory Status

Discontinued

2019
09 May
RX Application: 207873

Drug Name

MESALAMINE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2019-05-09

207873 / 1

Active Ingredient

MESALAMINE

Application Number

207873

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2019-05-09

Regulatory Status

RX

2022
06 May
Discontinued Application: 209970

Drug Name

MESALAMINE

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

2022-05-06

209970 / 1

Active Ingredient

MESALAMINE

Application Number

209970

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

2022-05-06

Regulatory Status

Discontinued

2001
27 Apr
Discontinued Application: 75764

Drug Name

MESNA

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2001-04-27

75764 / 1

Active Ingredient

MESNA

Application Number

75764

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2001-04-27

Regulatory Status

Discontinued

2019
20 Mar
RX Application: 211455

Drug Name

METHYLERGONOVINE MALEATE

Product Number

1

Dosage Form

-

Strength

0.2MG

Approval Date

2019-03-20

211455 / 1

Active Ingredient

METHYLERGONOVINE MALEATE

Application Number

211455

Product Number

1

Dosage Form

-

Strength

0.2MG

Approval Date

2019-03-20

Regulatory Status

RX

2012
19 Jul
RX Application: 77707

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2012-07-19

77707 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

77707

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2012-07-19

Regulatory Status

RX

2012
19 Jul
RX Application: 77707

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2012-07-19

77707 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

77707

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2012-07-19

Regulatory Status

RX

2012
19 Jul
RX Application: 77707

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2012-07-19

77707 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

77707

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2012-07-19

Regulatory Status

RX

2012
19 Jul
Discontinued Application: 78873

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2012-07-19

78873 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

78873

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2012-07-19

Regulatory Status

Discontinued

2012
19 Jul
Discontinued Application: 78873

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2012-07-19

78873 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

78873

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2012-07-19

Regulatory Status

Discontinued

2012
19 Jul
Discontinued Application: 78873

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2012-07-19

78873 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

78873

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2012-07-19

Regulatory Status

Discontinued

-
Unclassified Application: 214202

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

-

214202 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

214202

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214202

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

-

214202 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

214202

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214202

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

-

214202 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

214202

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

-

Regulatory Status

Unclassified

2006
27 Oct
Discontinued Application: 40620

Drug Name

METHYLPREDNISOLONE ACETATE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2006-10-27

40620 / 1

Active Ingredient

METHYLPREDNISOLONE ACETATE

Application Number

40620

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2006-10-27

Regulatory Status

Discontinued

2006
27 Oct
Discontinued Application: 40620

Drug Name

METHYLPREDNISOLONE ACETATE

Product Number

2

Dosage Form

-

Strength

80MG/ML

Approval Date

2006-10-27

40620 / 2

Active Ingredient

METHYLPREDNISOLONE ACETATE

Application Number

40620

Product Number

2

Dosage Form

-

Strength

80MG/ML

Approval Date

2006-10-27

Regulatory Status

Discontinued

1991
27 Nov
RX Application: 73135

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1991-11-27

73135 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

73135

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1991-11-27

Regulatory Status

RX

1994
27 Jan
Discontinued Application: 74333

Drug Name

METOPROLOL TARTRATE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1994-01-27

74333 / 1

Active Ingredient

METOPROLOL TARTRATE

Application Number

74333

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1994-01-27

Regulatory Status

Discontinued

1994
27 Jan
Discontinued Application: 74333

Drug Name

METOPROLOL TARTRATE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1994-01-27

74333 / 2

Active Ingredient

METOPROLOL TARTRATE

Application Number

74333

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1994-01-27

Regulatory Status

Discontinued

1984
06 Nov
RX Application: 70027

Drug Name

METRONIDAZOLE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1984-11-06

70027 / 1

Active Ingredient

METRONIDAZOLE

Application Number

70027

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1984-11-06

Regulatory Status

RX

2021
30 Jul
Discontinued Application: 212125

Drug Name

MICAFUNGIN

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2021-07-30

212125 / 1

Active Ingredient

MICAFUNGIN SODIUM

Application Number

212125

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2021-07-30

Regulatory Status

Discontinued

2021
30 Jul
Discontinued Application: 212125

Drug Name

MICAFUNGIN

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2021-07-30

212125 / 2

Active Ingredient

MICAFUNGIN SODIUM

Application Number

212125

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2021-07-30

Regulatory Status

Discontinued

1992
30 Oct
Discontinued Application: 74030

Drug Name

MICONAZOLE NITRATE

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1992-10-30

74030 / 1

Active Ingredient

MICONAZOLE NITRATE

Application Number

74030

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1992-10-30

Regulatory Status

Discontinued

1996
27 Dec
RX Application: 20504

Drug Name

MICROZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1996-12-27

20504 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

20504

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1996-12-27

Regulatory Status

RX

2024
29 Apr
Discontinued Application: 216076

Drug Name

MIDOSTAURIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2024-04-29

216076 / 1

Active Ingredient

MIDOSTAURIN

Application Number

216076

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2024-04-29

Regulatory Status

Discontinued

2020
03 Aug
RX Application: 211436

Drug Name

MIFEPRISTONE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2020-08-03

211436 / 1

Active Ingredient

MIFEPRISTONE

Application Number

211436

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2020-08-03

Regulatory Status

RX

1998
22 Apr
Discontinued Application: 20713

Drug Name

MIRCETTE

Product Number

1

Dosage Form

-

Strength

0.15MG,N/A;0.02MG,0.01MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-04-22

20713 / 1

Active Ingredient

DESOGESTREL; ETHINYL ESTRADIOL

Application Number

20713

Product Number

1

Dosage Form

-

Strength

0.15MG,N/A;0.02MG,0.01MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-04-22

Regulatory Status

Discontinued

-
Unclassified Application: 76596

Drug Name

MODAFINIL

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

-

76596 / 1

Active Ingredient

MODAFINIL

Application Number

76596

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 76596

Drug Name

MODAFINIL

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

-

76596 / 2

Active Ingredient

MODAFINIL

Application Number

76596

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

-

Regulatory Status

Unclassified

2012
03 Aug
RX Application: 78605

Drug Name

MONTELUKAST SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-08-03

78605 / 1

Active Ingredient

MONTELUKAST SODIUM

Application Number

78605

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-08-03

Regulatory Status

RX

2012
03 Aug
RX Application: 78723

Drug Name

MONTELUKAST SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2012-08-03

78723 / 1

Active Ingredient

MONTELUKAST SODIUM

Application Number

78723

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2012-08-03

Regulatory Status

RX

2012
03 Aug
RX Application: 78723

Drug Name

MONTELUKAST SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-08-03

78723 / 2

Active Ingredient

MONTELUKAST SODIUM

Application Number

78723

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-08-03

Regulatory Status

RX

2012
03 Aug
Discontinued Application: 90955

Drug Name

MONTELUKAST SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/PACKET

Approval Date

2012-08-03

90955 / 1

Active Ingredient

MONTELUKAST SODIUM

Application Number

90955

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/PACKET

Approval Date

2012-08-03

Regulatory Status

Discontinued

2014
29 Dec
Discontinued Application: 202718

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2014-12-29

202718 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

202718

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2014-12-29

Regulatory Status

Discontinued

2014
29 Dec
Discontinued Application: 202718

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2014-12-29

202718 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

202718

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2014-12-29

Regulatory Status

Discontinued

2014
29 Dec
Discontinued Application: 202718

Drug Name

MORPHINE SULFATE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2014-12-29

202718 / 3

Active Ingredient

MORPHINE SULFATE

Application Number

202718

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2014-12-29

Regulatory Status

Discontinued

2014
29 Dec
Discontinued Application: 202718

Drug Name

MORPHINE SULFATE

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

2014-12-29

202718 / 4

Active Ingredient

MORPHINE SULFATE

Application Number

202718

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

2014-12-29

Regulatory Status

Discontinued

2014
29 Dec
Discontinued Application: 202718

Drug Name

MORPHINE SULFATE

Product Number

5

Dosage Form

-

Strength

80MG

Approval Date

2014-12-29

202718 / 5

Active Ingredient

MORPHINE SULFATE

Application Number

202718

Product Number

5

Dosage Form

-

Strength

80MG

Approval Date

2014-12-29

Regulatory Status

Discontinued

2014
29 Dec
Discontinued Application: 202718

Drug Name

MORPHINE SULFATE

Product Number

6

Dosage Form

-

Strength

100MG

Approval Date

2014-12-29

202718 / 6

Active Ingredient

MORPHINE SULFATE

Application Number

202718

Product Number

6

Dosage Form

-

Strength

100MG

Approval Date

2014-12-29

Regulatory Status

Discontinued

2015
03 Jun
Discontinued Application: 202718

Drug Name

MORPHINE SULFATE

Product Number

7

Dosage Form

-

Strength

40MG

Approval Date

2015-06-03

202718 / 7

Active Ingredient

MORPHINE SULFATE

Application Number

202718

Product Number

7

Dosage Form

-

Strength

40MG

Approval Date

2015-06-03

Regulatory Status

Discontinued

2015
03 Jun
Discontinued Application: 202718

Drug Name

MORPHINE SULFATE

Product Number

8

Dosage Form

-

Strength

70MG

Approval Date

2015-06-03

202718 / 8

Active Ingredient

MORPHINE SULFATE

Application Number

202718

Product Number

8

Dosage Form

-

Strength

70MG

Approval Date

2015-06-03

Regulatory Status

Discontinued

2014
18 Feb
RX Application: 77437

Drug Name

MOXIFLOXACIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2014-02-18

77437 / 1

Active Ingredient

MOXIFLOXACIN HYDROCHLORIDE

Application Number

77437

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2014-02-18

Regulatory Status

RX

-
Unclassified Application: 78073

Drug Name

MOXIFLOXACIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

-

78073 / 1

Active Ingredient

MOXIFLOXACIN HYDROCHLORIDE

Application Number

78073

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

-

Regulatory Status

Unclassified

2009
04 May
Discontinued Application: 65457

Drug Name

MYCOPHENOLATE MOFETIL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2009-05-04

65457 / 1

Active Ingredient

MYCOPHENOLATE MOFETIL

Application Number

65457

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2009-05-04

Regulatory Status

Discontinued

2009
06 May
RX Application: 65491

Drug Name

MYCOPHENOLATE MOFETIL

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2009-05-06

65491 / 1

Active Ingredient

MYCOPHENOLATE MOFETIL

Application Number

65491

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2009-05-06

Regulatory Status

RX

2022
25 Jan
Discontinued Application: 211272

Drug Name

MYCOPHENOLATE MOFETIL

Product Number

1

Dosage Form

-

Strength

200MG/ML

Approval Date

2022-01-25

211272 / 1

Active Ingredient

MYCOPHENOLATE MOFETIL

Application Number

211272

Product Number

1

Dosage Form

-

Strength

200MG/ML

Approval Date

2022-01-25

Regulatory Status

Discontinued

2014
30 Oct
Discontinued Application: 202720

Drug Name

MYCOPHENOLATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 180MG BASE

Approval Date

2014-10-30

202720 / 1

Active Ingredient

MYCOPHENOLATE SODIUM

Application Number

202720

Product Number

1

Dosage Form

-

Strength

EQ 180MG BASE

Approval Date

2014-10-30

Regulatory Status

Discontinued

2014
30 Oct
Discontinued Application: 202720

Drug Name

MYCOPHENOLATE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 360MG BASE

Approval Date

2014-10-30

202720 / 2

Active Ingredient

MYCOPHENOLATE SODIUM

Application Number

202720

Product Number

2

Dosage Form

-

Strength

EQ 360MG BASE

Approval Date

2014-10-30

Regulatory Status

Discontinued

1994
31 Aug
Discontinued Application: 74368

Drug Name

NADOLOL

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1994-08-31

74368 / 1

Active Ingredient

NADOLOL

Application Number

74368

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1994-08-31

Regulatory Status

Discontinued

1994
31 Aug
Discontinued Application: 74368

Drug Name

NADOLOL

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

1994-08-31

74368 / 2

Active Ingredient

NADOLOL

Application Number

74368

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

1994-08-31

Regulatory Status

Discontinued

1994
31 Aug
Discontinued Application: 74368

Drug Name

NADOLOL

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

1994-08-31

74368 / 3

Active Ingredient

NADOLOL

Application Number

74368

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

1994-08-31

Regulatory Status

Discontinued

2019
19 Apr
OTC Application: 209522

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

4MG/SPRAY

Approval Date

2019-04-19

209522 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

209522

Product Number

1

Dosage Form

-

Strength

4MG/SPRAY

Approval Date

2019-04-19

Regulatory Status

OTC

2023
06 Jul
Discontinued Application: 213195

Drug Name

NALTREXONE

Product Number

1

Dosage Form

-

Strength

380MG/VIAL

Approval Date

2023-07-06

213195 / 1

Active Ingredient

NALTREXONE

Application Number

213195

Product Number

1

Dosage Form

-

Strength

380MG/VIAL

Approval Date

2023-07-06

Regulatory Status

Discontinued

1993
21 Dec
Discontinued Application: 74207

Drug Name

NAPROXEN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1993-12-21

74207 / 1

Active Ingredient

NAPROXEN

Application Number

74207

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1993-12-21

Regulatory Status

Discontinued

1993
21 Dec
Discontinued Application: 74207

Drug Name

NAPROXEN

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

1993-12-21

74207 / 2

Active Ingredient

NAPROXEN

Application Number

74207

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

1993-12-21

Regulatory Status

Discontinued

1993
21 Dec
Discontinued Application: 74207

Drug Name

NAPROXEN

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1993-12-21

74207 / 3

Active Ingredient

NAPROXEN

Application Number

74207

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1993-12-21

Regulatory Status

Discontinued

1994
27 Jan
Discontinued Application: 74289

Drug Name

NAPROXEN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1994-01-27

74289 / 1

Active Ingredient

NAPROXEN SODIUM

Application Number

74289

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1994-01-27

Regulatory Status

Discontinued

1994
27 Jan
Discontinued Application: 74289

Drug Name

NAPROXEN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1994-01-27

74289 / 2

Active Ingredient

NAPROXEN SODIUM

Application Number

74289

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1994-01-27

Regulatory Status

Discontinued

1995
08 Mar
Discontinued Application: 20409

Drug Name

NASAREL

Product Number

1

Dosage Form

-

Strength

0.029MG/SPRAY

Approval Date

1995-03-08

20409 / 1

Active Ingredient

FLUNISOLIDE

Application Number

20409

Product Number

1

Dosage Form

-

Strength

0.029MG/SPRAY

Approval Date

1995-03-08

Regulatory Status

Discontinued

2009
09 Sep
Discontinued Application: 77467

Drug Name

NATEGLINIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2009-09-09

77467 / 1

Active Ingredient

NATEGLINIDE

Application Number

77467

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2009-09-09

Regulatory Status

Discontinued

2009
09 Sep
Discontinued Application: 77467

Drug Name

NATEGLINIDE

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2009-09-09

77467 / 2

Active Ingredient

NATEGLINIDE

Application Number

77467

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2009-09-09

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 17060

Drug Name

NOR-QD

Product Number

1

Dosage Form

-

Strength

0.35MG

Approval Date

1982-01-01

17060 / 1

Active Ingredient

NORETHINDRONE

Application Number

17060

Product Number

1

Dosage Form

-

Strength

0.35MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
10 May
Discontinued Application: 18668

Drug Name

NORDETTE-21

Product Number

1

Dosage Form

-

Strength

0.03MG;0.15MG

Approval Date

1982-05-10

18668 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

18668

Product Number

1

Dosage Form

-

Strength

0.03MG;0.15MG

Approval Date

1982-05-10

Regulatory Status

Discontinued

1982
21 Jul
Discontinued Application: 18782

Drug Name

NORDETTE-28

Product Number

1

Dosage Form

-

Strength

0.03MG;0.15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-07-21

18782 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

18782

Product Number

1

Dosage Form

-

Strength

0.03MG;0.15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-07-21

Regulatory Status

Discontinued

2010
22 Dec
Discontinued Application: 22573

Drug Name

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Product Number

1

Dosage Form

-

Strength

0.025MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2010-12-22

22573 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

22573

Product Number

1

Dosage Form

-

Strength

0.025MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2010-12-22

Regulatory Status

Discontinued

2023
05 Dec
RX Application: 210317

Drug Name

OCTREOTIDE ACETATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/VIAL

Approval Date

2023-12-05

210317 / 1

Active Ingredient

OCTREOTIDE ACETATE

Application Number

210317

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/VIAL

Approval Date

2023-12-05

Regulatory Status

RX

2023
05 Dec
RX Application: 210317

Drug Name

OCTREOTIDE ACETATE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE/VIAL

Approval Date

2023-12-05

210317 / 2

Active Ingredient

OCTREOTIDE ACETATE

Application Number

210317

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE/VIAL

Approval Date

2023-12-05

Regulatory Status

RX

2023
05 Dec
RX Application: 210317

Drug Name

OCTREOTIDE ACETATE

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE/VIAL

Approval Date

2023-12-05

210317 / 3

Active Ingredient

OCTREOTIDE ACETATE

Application Number

210317

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE/VIAL

Approval Date

2023-12-05

Regulatory Status

RX

2011
24 Oct
Discontinued Application: 76000

Drug Name

OLANZAPINE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2011-10-24

76000 / 1

Active Ingredient

OLANZAPINE

Application Number

76000

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2011-10-24

Regulatory Status

Discontinued

2011
24 Oct
Discontinued Application: 76000

Drug Name

OLANZAPINE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2011-10-24

76000 / 2

Active Ingredient

OLANZAPINE

Application Number

76000

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2011-10-24

Regulatory Status

Discontinued

2011
24 Oct
Discontinued Application: 76000

Drug Name

OLANZAPINE

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2011-10-24

76000 / 3

Active Ingredient

OLANZAPINE

Application Number

76000

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2011-10-24

Regulatory Status

Discontinued

2011
24 Oct
Discontinued Application: 76000

Drug Name

OLANZAPINE

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2011-10-24

76000 / 4

Active Ingredient

OLANZAPINE

Application Number

76000

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2011-10-24

Regulatory Status

Discontinued

2011
24 Oct
Discontinued Application: 76000

Drug Name

OLANZAPINE

Product Number

5

Dosage Form

-

Strength

15MG

Approval Date

2011-10-24

76000 / 5

Active Ingredient

OLANZAPINE

Application Number

76000

Product Number

5

Dosage Form

-

Strength

15MG

Approval Date

2011-10-24

Regulatory Status

Discontinued

2012
19 Jun
RX Application: 77528

Drug Name

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE;EQ 6MG BASE

Approval Date

2012-06-19

77528 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Application Number

77528

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE;EQ 6MG BASE

Approval Date

2012-06-19

Regulatory Status

RX

2012
19 Jun
RX Application: 77528

Drug Name

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE;EQ 12MG BASE

Approval Date

2012-06-19

77528 / 2

Active Ingredient

FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Application Number

77528

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE;EQ 12MG BASE

Approval Date

2012-06-19

Regulatory Status

RX

2012
19 Jun
RX Application: 77528

Drug Name

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE;EQ 6MG BASE

Approval Date

2012-06-19

77528 / 3

Active Ingredient

FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Application Number

77528

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE;EQ 6MG BASE

Approval Date

2012-06-19

Regulatory Status

RX

2012
19 Jun
RX Application: 77528

Drug Name

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE;EQ 12MG BASE

Approval Date

2012-06-19

77528 / 4

Active Ingredient

FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Application Number

77528

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE;EQ 12MG BASE

Approval Date

2012-06-19

Regulatory Status

RX

2013
25 Mar
RX Application: 202074

Drug Name

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE;EQ 3MG BASE

Approval Date

2013-03-25

202074 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Application Number

202074

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE;EQ 3MG BASE

Approval Date

2013-03-25

Regulatory Status

RX

2017
24 Apr
Discontinued Application: 91079

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2017-04-24

91079 / 1

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

91079

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2017-04-24

Regulatory Status

Discontinued

2017
24 Apr
Discontinued Application: 91079

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2017-04-24

91079 / 2

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

91079

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2017-04-24

Regulatory Status

Discontinued

2017
24 Apr
Discontinued Application: 91079

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2017-04-24

91079 / 3

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

91079

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2017-04-24

Regulatory Status

Discontinued

2017
24 Apr
Discontinued Application: 200532

Drug Name

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2017-04-24

200532 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

200532

Product Number

1

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2017-04-24

Regulatory Status

Discontinued

2017
24 Apr
Discontinued Application: 200532

Drug Name

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;40MG

Approval Date

2017-04-24

200532 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

200532

Product Number

2

Dosage Form

-

Strength

12.5MG;40MG

Approval Date

2017-04-24

Regulatory Status

Discontinued

2017
24 Apr
Discontinued Application: 200532

Drug Name

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;40MG

Approval Date

2017-04-24

200532 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

200532

Product Number

3

Dosage Form

-

Strength

25MG;40MG

Approval Date

2017-04-24

Regulatory Status

Discontinued

2016
03 Nov
RX Application: 202491

Drug Name

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;12.5MG;20MG

Approval Date

2016-11-03

202491 / 1

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

202491

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;12.5MG;20MG

Approval Date

2016-11-03

Regulatory Status

RX

2016
03 Nov
RX Application: 202491

Drug Name

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;12.5MG;40MG

Approval Date

2016-11-03

202491 / 2

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

202491

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;12.5MG;40MG

Approval Date

2016-11-03

Regulatory Status

RX

2016
03 Nov
RX Application: 202491

Drug Name

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;25MG;40MG

Approval Date

2016-11-03

202491 / 3

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

202491

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;25MG;40MG

Approval Date

2016-11-03

Regulatory Status

RX

2016
03 Nov
RX Application: 202491

Drug Name

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;12.5MG;40MG

Approval Date

2016-11-03

202491 / 4

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

202491

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;12.5MG;40MG

Approval Date

2016-11-03

Regulatory Status

RX

2016
03 Nov
RX Application: 202491

Drug Name

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE

Product Number

5

Dosage Form

-

Strength

EQ 10MG BASE;25MG;40MG

Approval Date

2016-11-03

202491 / 5

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

202491

Product Number

5

Dosage Form

-

Strength

EQ 10MG BASE;25MG;40MG

Approval Date

2016-11-03

Regulatory Status

RX

2017
13 Jun
RX Application: 204661

Drug Name

OMEPRAZOLE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2017-06-13

204661 / 1

Active Ingredient

OMEPRAZOLE

Application Number

204661

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2017-06-13

Regulatory Status

RX

2017
13 Jun
Discontinued Application: 204661

Drug Name

OMEPRAZOLE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2017-06-13

204661 / 2

Active Ingredient

OMEPRAZOLE

Application Number

204661

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2017-06-13

Regulatory Status

Discontinued

2021
25 Aug
RX Application: 213977

Drug Name

ONSURA

Product Number

1

Dosage Form

-

Strength

0.035MG/24HR;0.15MG/24HR

Approval Date

2021-08-25

213977 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORELGESTROMIN

Application Number

213977

Product Number

1

Dosage Form

-

Strength

0.035MG/24HR;0.15MG/24HR

Approval Date

2021-08-25

Regulatory Status

RX

2019
27 Feb
RX Application: 211125

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

2019-02-27

211125 / 1

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

211125

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

2019-02-27

Regulatory Status

RX

2009
07 Aug
Discontinued Application: 22160

Drug Name

OXALIPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2009-08-07

22160 / 1

Active Ingredient

OXALIPLATIN

Application Number

22160

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2009-08-07

Regulatory Status

Discontinued

2009
07 Aug
Discontinued Application: 22160

Drug Name

OXALIPLATIN

Product Number

2

Dosage Form

-

Strength

100MG/20ML (5MG/ML)

Approval Date

2009-08-07

22160 / 2

Active Ingredient

OXALIPLATIN

Application Number

22160

Product Number

2

Dosage Form

-

Strength

100MG/20ML (5MG/ML)

Approval Date

2009-08-07

Regulatory Status

Discontinued

1988
14 Nov
RX Application: 71655

Drug Name

OXYBUTYNIN CHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1988-11-14

71655 / 1

Active Ingredient

OXYBUTYNIN CHLORIDE

Application Number

71655

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1988-11-14

Regulatory Status

RX

-
Unclassified Application: 211812

Drug Name

OXYMETAZOLINE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

-

211812 / 1

Active Ingredient

OXYMETAZOLINE

Application Number

211812

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

-

Regulatory Status

Unclassified

2002
25 Jan
RX Application: 75184

Drug Name

PACLITAXEL

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2002-01-25

75184 / 1

Active Ingredient

PACLITAXEL

Application Number

75184

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2002-01-25

Regulatory Status

RX

2002
25 Jan
Discontinued Application: 75297

Drug Name

PACLITAXEL

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2002-01-25

75297 / 1

Active Ingredient

PACLITAXEL

Application Number

75297

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2002-01-25

Regulatory Status

Discontinued

2018
23 Mar
RX Application: 90713

Drug Name

PALONOSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

Approval Date

2018-03-23

90713 / 1

Active Ingredient

PALONOSETRON HYDROCHLORIDE

Application Number

90713

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

Approval Date

2018-03-23

Regulatory Status

RX

2018
23 Mar
Discontinued Application: 90713

Drug Name

PALONOSETRON HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)

Approval Date

2018-03-23

90713 / 2

Active Ingredient

PALONOSETRON HYDROCHLORIDE

Application Number

90713

Product Number

2

Dosage Form

-

Strength

EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)

Approval Date

2018-03-23

Regulatory Status

Discontinued

2002
27 Mar
Discontinued Application: 76153

Drug Name

PAMIDRONATE DISODIUM

Product Number

1

Dosage Form

-

Strength

30MG/10ML (3MG/ML)

Approval Date

2002-03-27

76153 / 1

Active Ingredient

PAMIDRONATE DISODIUM

Application Number

76153

Product Number

1

Dosage Form

-

Strength

30MG/10ML (3MG/ML)

Approval Date

2002-03-27

Regulatory Status

Discontinued

2002
27 Mar
Discontinued Application: 76153

Drug Name

PAMIDRONATE DISODIUM

Product Number

2

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

2002-03-27

76153 / 2

Active Ingredient

PAMIDRONATE DISODIUM

Application Number

76153

Product Number

2

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

2002-03-27

Regulatory Status

Discontinued

2013
27 Sep
RX Application: 90829

Drug Name

PARICALCITOL

Product Number

1

Dosage Form

-

Strength

1MCG

Approval Date

2013-09-27

90829 / 1

Active Ingredient

PARICALCITOL

Application Number

90829

Product Number

1

Dosage Form

-

Strength

1MCG

Approval Date

2013-09-27

Regulatory Status

RX

2013
27 Sep
RX Application: 90829

Drug Name

PARICALCITOL

Product Number

2

Dosage Form

-

Strength

2MCG

Approval Date

2013-09-27

90829 / 2

Active Ingredient

PARICALCITOL

Application Number

90829

Product Number

2

Dosage Form

-

Strength

2MCG

Approval Date

2013-09-27

Regulatory Status

RX

2013
27 Sep
RX Application: 90829

Drug Name

PARICALCITOL

Product Number

3

Dosage Form

-

Strength

4MCG

Approval Date

2013-09-27

90829 / 3

Active Ingredient

PARICALCITOL

Application Number

90829

Product Number

3

Dosage Form

-

Strength

4MCG

Approval Date

2013-09-27

Regulatory Status

RX

-
Unclassified Application: 91583

Drug Name

PARICALCITOL

Product Number

1

Dosage Form

-

Strength

2MCG/ML

Approval Date

-

91583 / 1

Active Ingredient

PARICALCITOL

Application Number

91583

Product Number

1

Dosage Form

-

Strength

2MCG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 91583

Drug Name

PARICALCITOL

Product Number

2

Dosage Form

-

Strength

5MCG/ML

Approval Date

-

91583 / 2

Active Ingredient

PARICALCITOL

Application Number

91583

Product Number

2

Dosage Form

-

Strength

5MCG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 91583

Drug Name

PARICALCITOL

Product Number

3

Dosage Form

-

Strength

10MCG/ML

Approval Date

-

91583 / 3

Active Ingredient

PARICALCITOL

Application Number

91583

Product Number

3

Dosage Form

-

Strength

10MCG/ML

Approval Date

-

Regulatory Status

Unclassified

2007
29 Jun
Discontinued Application: 77082

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-06-29

77082 / 1

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

77082

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-06-29

Regulatory Status

Discontinued

2007
29 Jun
Discontinued Application: 77082

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2007-06-29

77082 / 2

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

77082

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2007-06-29

Regulatory Status

Discontinued

2007
29 Jun
Discontinued Application: 77082

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2007-06-29

77082 / 3

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

77082

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2007-06-29

Regulatory Status

Discontinued

2007
29 Jun
Discontinued Application: 77082

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2007-06-29

77082 / 4

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

77082

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2007-06-29

Regulatory Status

Discontinued

-
Unclassified Application: 90352

Drug Name

PEMETREXED

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

-

90352 / 1

Active Ingredient

PEMETREXED SODIUM

Application Number

90352

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

-

Regulatory Status

Unclassified

1999
29 Jan
Discontinued Application: 75030

Drug Name

PEMOLINE

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

1999-01-29

75030 / 1

Active Ingredient

PEMOLINE

Application Number

75030

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

1999-01-29

Regulatory Status

Discontinued

1999
29 Jan
Discontinued Application: 75030

Drug Name

PEMOLINE

Product Number

2

Dosage Form

-

Strength

75MG

Approval Date

1999-01-29

75030 / 2

Active Ingredient

PEMOLINE

Application Number

75030

Product Number

2

Dosage Form

-

Strength

75MG

Approval Date

1999-01-29

Regulatory Status

Discontinued

2000
22 Feb
Discontinued Application: 75030

Drug Name

PEMOLINE

Product Number

3

Dosage Form

-

Strength

18.75MG

Approval Date

2000-02-22

75030 / 3

Active Ingredient

PEMOLINE

Application Number

75030

Product Number

3

Dosage Form

-

Strength

18.75MG

Approval Date

2000-02-22

Regulatory Status

Discontinued

2000
18 Feb
Discontinued Application: 75555

Drug Name

PEMOLINE

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

2000-02-18

75555 / 1

Active Ingredient

PEMOLINE

Application Number

75555

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

2000-02-18

Regulatory Status

Discontinued

2022
09 Nov
RX Application: 212710

Drug Name

PENCICLOVIR

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2022-11-09

212710 / 1

Active Ingredient

PENCICLOVIR

Application Number

212710

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2022-11-09

Regulatory Status

RX

2020
13 Feb
Discontinued Application: 211497

Drug Name

PENICILLAMINE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2020-02-13

211497 / 1

Active Ingredient

PENICILLAMINE

Application Number

211497

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2020-02-13

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 60456

Drug Name

PENICILLIN-VK

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

60456 / 1

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

60456

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 60456

Drug Name

PENICILLIN-VK

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

60456 / 2

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

60456

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 60711

Drug Name

PENICILLIN-VK

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

60711 / 2

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

60711

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 60711

Drug Name

PENICILLIN-VK

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

60711 / 3

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

60711

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Regulatory Status

RX

2025
23 May
RX Application: 209801

Drug Name

PERAMPANEL

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2025-05-23

209801 / 1

Active Ingredient

PERAMPANEL

Application Number

209801

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2025-05-23

Regulatory Status

RX

2025
23 May
RX Application: 209801

Drug Name

PERAMPANEL

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2025-05-23

209801 / 2

Active Ingredient

PERAMPANEL

Application Number

209801

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2025-05-23

Regulatory Status

RX

2025
23 May
RX Application: 209801

Drug Name

PERAMPANEL

Product Number

3

Dosage Form

-

Strength

6MG

Approval Date

2025-05-23

209801 / 3

Active Ingredient

PERAMPANEL

Application Number

209801

Product Number

3

Dosage Form

-

Strength

6MG

Approval Date

2025-05-23

Regulatory Status

RX

2025
23 May
RX Application: 209801

Drug Name

PERAMPANEL

Product Number

4

Dosage Form

-

Strength

8MG

Approval Date

2025-05-23

209801 / 4

Active Ingredient

PERAMPANEL

Application Number

209801

Product Number

4

Dosage Form

-

Strength

8MG

Approval Date

2025-05-23

Regulatory Status

RX

2025
23 May
RX Application: 209801

Drug Name

PERAMPANEL

Product Number

5

Dosage Form

-

Strength

10MG

Approval Date

2025-05-23

209801 / 5

Active Ingredient

PERAMPANEL

Application Number

209801

Product Number

5

Dosage Form

-

Strength

10MG

Approval Date

2025-05-23

Regulatory Status

RX

2025
23 May
RX Application: 209801

Drug Name

PERAMPANEL

Product Number

6

Dosage Form

-

Strength

12MG

Approval Date

2025-05-23

209801 / 6

Active Ingredient

PERAMPANEL

Application Number

209801

Product Number

6

Dosage Form

-

Strength

12MG

Approval Date

2025-05-23

Regulatory Status

RX

-
Unclassified Application: 214750

Drug Name

PIMAVANSERIN

Product Number

1

Dosage Form

-

Strength

EQ 34MG BASE

Approval Date

-

214750 / 1

Active Ingredient

PIMAVANSERIN

Application Number

214750

Product Number

1

Dosage Form

-

Strength

EQ 34MG BASE

Approval Date

-

Regulatory Status

Unclassified

2014
10 Jan
RX Application: 77210

Drug Name

PIOGLITAZONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2014-01-10

77210 / 1

Active Ingredient

PIOGLITAZONE HYDROCHLORIDE

Application Number

77210

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2014-01-10

Regulatory Status

RX

2014
10 Jan
RX Application: 77210

Drug Name

PIOGLITAZONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2014-01-10

77210 / 2

Active Ingredient

PIOGLITAZONE HYDROCHLORIDE

Application Number

77210

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2014-01-10

Regulatory Status

RX

2014
10 Jan
RX Application: 77210

Drug Name

PIOGLITAZONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2014-01-10

77210 / 3

Active Ingredient

PIOGLITAZONE HYDROCHLORIDE

Application Number

77210

Product Number

3

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2014-01-10

Regulatory Status

RX

2014
10 Mar
RX Application: 91155

Drug Name

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG;EQ 15MG BASE

Approval Date

2014-03-10

91155 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Application Number

91155

Product Number

1

Dosage Form

-

Strength

500MG;EQ 15MG BASE

Approval Date

2014-03-10

Regulatory Status

RX

2014
10 Mar
RX Application: 91155

Drug Name

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

850MG;EQ 15MG BASE

Approval Date

2014-03-10

91155 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Application Number

91155

Product Number

2

Dosage Form

-

Strength

850MG;EQ 15MG BASE

Approval Date

2014-03-10

Regulatory Status

RX

2022
25 Jan
RX Application: 212759

Drug Name

PIRFENIDONE

Product Number

1

Dosage Form

-

Strength

267MG

Approval Date

2022-01-25

212759 / 1

Active Ingredient

PIRFENIDONE

Application Number

212759

Product Number

1

Dosage Form

-

Strength

267MG

Approval Date

2022-01-25

Regulatory Status

RX

2022
25 Jan
RX Application: 212759

Drug Name

PIRFENIDONE

Product Number

2

Dosage Form

-

Strength

801MG

Approval Date

2022-01-25

212759 / 2

Active Ingredient

PIRFENIDONE

Application Number

212759

Product Number

2

Dosage Form

-

Strength

801MG

Approval Date

2022-01-25

Regulatory Status

RX

1992
28 Aug
Discontinued Application: 74103

Drug Name

PIROXICAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1992-08-28

74103 / 1

Active Ingredient

PIROXICAM

Application Number

74103

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1992-08-28

Regulatory Status

Discontinued

1992
28 Aug
Discontinued Application: 74103

Drug Name

PIROXICAM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1992-08-28

74103 / 2

Active Ingredient

PIROXICAM

Application Number

74103

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1992-08-28

Regulatory Status

Discontinued

2023
24 Jul
Discontinued Application: 205197

Drug Name

PLERIXAFOR

Product Number

1

Dosage Form

-

Strength

24MG/1.2ML (20MG/ML)

Approval Date

2023-07-24

205197 / 1

Active Ingredient

PLERIXAFOR

Application Number

205197

Product Number

1

Dosage Form

-

Strength

24MG/1.2ML (20MG/ML)

Approval Date

2023-07-24

Regulatory Status

Discontinued

2006
04 May
Discontinued Application: 77445

Drug Name

POLYETHYLENE GLYCOL 3350

Product Number

1

Dosage Form

-

Strength

17GM/SCOOPFUL

Approval Date

2006-05-04

77445 / 1

Active Ingredient

POLYETHYLENE GLYCOL 3350

Application Number

77445

Product Number

1

Dosage Form

-

Strength

17GM/SCOOPFUL

Approval Date

2006-05-04

Regulatory Status

Discontinued

2022
04 May
RX Application: 209956

Drug Name

POMALIDOMIDE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2022-05-04

209956 / 1

Active Ingredient

POMALIDOMIDE

Application Number

209956

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2022-05-04

Regulatory Status

RX

2022
04 May
RX Application: 209956

Drug Name

POMALIDOMIDE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2022-05-04

209956 / 2

Active Ingredient

POMALIDOMIDE

Application Number

209956

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2022-05-04

Regulatory Status

RX

2022
04 May
RX Application: 209956

Drug Name

POMALIDOMIDE

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2022-05-04

209956 / 3

Active Ingredient

POMALIDOMIDE

Application Number

209956

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2022-05-04

Regulatory Status

RX

2022
04 May
RX Application: 209956

Drug Name

POMALIDOMIDE

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

2022-05-04

209956 / 4

Active Ingredient

POMALIDOMIDE

Application Number

209956

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

2022-05-04

Regulatory Status

RX

2018
05 Mar
RX Application: 209758

Drug Name

POTASSIUM CITRATE

Product Number

1

Dosage Form

-

Strength

5MEQ

Approval Date

2018-03-05

209758 / 1

Active Ingredient

POTASSIUM CITRATE

Application Number

209758

Product Number

1

Dosage Form

-

Strength

5MEQ

Approval Date

2018-03-05

Regulatory Status

RX

2018
05 Mar
RX Application: 209758

Drug Name

POTASSIUM CITRATE

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2018-03-05

209758 / 2

Active Ingredient

POTASSIUM CITRATE

Application Number

209758

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2018-03-05

Regulatory Status

RX

2018
05 Mar
RX Application: 209758

Drug Name

POTASSIUM CITRATE

Product Number

3

Dosage Form

-

Strength

15MEQ

Approval Date

2018-03-05

209758 / 3

Active Ingredient

POTASSIUM CITRATE

Application Number

209758

Product Number

3

Dosage Form

-

Strength

15MEQ

Approval Date

2018-03-05

Regulatory Status

RX

-
Unclassified Application: 206167

Drug Name

PRALATREXATE

Product Number

1

Dosage Form

-

Strength

20MG/1ML

Approval Date

-

206167 / 1

Active Ingredient

PRALATREXATE

Application Number

206167

Product Number

1

Dosage Form

-

Strength

20MG/1ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 206167

Drug Name

PRALATREXATE

Product Number

2

Dosage Form

-

Strength

40MG/2ML

Approval Date

-

206167 / 2

Active Ingredient

PRALATREXATE

Application Number

206167

Product Number

2

Dosage Form

-

Strength

40MG/2ML

Approval Date

-

Regulatory Status

Unclassified

1988
12 Sep
RX Application: 71745

Drug Name

PRAZOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1988-09-12

71745 / 1

Active Ingredient

PRAZOSIN HYDROCHLORIDE

Application Number

71745

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1988-09-12

Regulatory Status

RX

1988
12 Sep
RX Application: 71745

Drug Name

PRAZOSIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

1988-09-12

71745 / 2

Active Ingredient

PRAZOSIN HYDROCHLORIDE

Application Number

71745

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

1988-09-12

Regulatory Status

RX

1988
12 Sep
RX Application: 71745

Drug Name

PRAZOSIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1988-09-12

71745 / 3

Active Ingredient

PRAZOSIN HYDROCHLORIDE

Application Number

71745

Product Number

3

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1988-09-12

Regulatory Status

RX

-
Unclassified Application: 71995

Drug Name

PRAZOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

-

71995 / 1

Active Ingredient

PRAZOSIN HYDROCHLORIDE

Application Number

71995

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

-

Regulatory Status

Unclassified

2000
19 Jan
Discontinued Application: 40322

Drug Name

PREDNISOLONE

Product Number

1

Dosage Form

-

Strength

15MG/5ML

Approval Date

2000-01-19

40322 / 1

Active Ingredient

PREDNISOLONE

Application Number

40322

Product Number

1

Dosage Form

-

Strength

15MG/5ML

Approval Date

2000-01-19

Regulatory Status

Discontinued

1999
22 Oct
Discontinued Application: 21040

Drug Name

PREFEST

Product Number

1

Dosage Form

-

Strength

1MG,1MG;N/A,0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-10-22

21040 / 1

Active Ingredient

ESTRADIOL; NORGESTIMATE

Application Number

21040

Product Number

1

Dosage Form

-

Strength

1MG,1MG;N/A,0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-10-22

Regulatory Status

Discontinued

2019
19 Jul
Discontinued Application: 91219

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-07-19

91219 / 1

Active Ingredient

PREGABALIN

Application Number

91219

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-07-19

Regulatory Status

Discontinued

2019
19 Jul
Discontinued Application: 91219

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2019-07-19

91219 / 2

Active Ingredient

PREGABALIN

Application Number

91219

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2019-07-19

Regulatory Status

Discontinued

2019
19 Jul
Discontinued Application: 91224

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2019-07-19

91224 / 1

Active Ingredient

PREGABALIN

Application Number

91224

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2019-07-19

Regulatory Status

Discontinued

2019
19 Jul
Discontinued Application: 91224

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2019-07-19

91224 / 2

Active Ingredient

PREGABALIN

Application Number

91224

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2019-07-19

Regulatory Status

Discontinued

2019
19 Jul
Discontinued Application: 91224

Drug Name

PREGABALIN

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2019-07-19

91224 / 3

Active Ingredient

PREGABALIN

Application Number

91224

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2019-07-19

Regulatory Status

Discontinued

2019
19 Jul
Discontinued Application: 91224

Drug Name

PREGABALIN

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2019-07-19

91224 / 4

Active Ingredient

PREGABALIN

Application Number

91224

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2019-07-19

Regulatory Status

Discontinued

2019
19 Jul
Discontinued Application: 91224

Drug Name

PREGABALIN

Product Number

5

Dosage Form

-

Strength

225MG

Approval Date

2019-07-19

91224 / 5

Active Ingredient

PREGABALIN

Application Number

91224

Product Number

5

Dosage Form

-

Strength

225MG

Approval Date

2019-07-19

Regulatory Status

Discontinued

2019
19 Jul
Discontinued Application: 91224

Drug Name

PREGABALIN

Product Number

6

Dosage Form

-

Strength

300MG

Approval Date

2019-07-19

91224 / 6

Active Ingredient

PREGABALIN

Application Number

91224

Product Number

6

Dosage Form

-

Strength

300MG

Approval Date

2019-07-19

Regulatory Status

Discontinued

1998
01 Sep
Discontinued Application: 20946

Drug Name

PREVEN EMERGENCY CONTRACEPTIVE KIT

Product Number

1

Dosage Form

-

Strength

0.05MG;0.25MG

Approval Date

1998-09-01

20946 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

20946

Product Number

1

Dosage Form

-

Strength

0.05MG;0.25MG

Approval Date

1998-09-01

Regulatory Status

Discontinued

2018
21 Dec
Discontinued Application: 205636

Drug Name

PROAIR DIGIHALER

Product Number

2

Dosage Form

-

Strength

EQ 0.09MG BASE/INH

Approval Date

2018-12-21

205636 / 2

Active Ingredient

ALBUTEROL SULFATE

Application Number

205636

Product Number

2

Dosage Form

-

Strength

EQ 0.09MG BASE/INH

Approval Date

2018-12-21

Regulatory Status

Discontinued

2004
29 Oct
RX Application: 21457

Drug Name

PROAIR HFA

Product Number

1

Dosage Form

-

Strength

EQ 0.09MG BASE/INH

Approval Date

2004-10-29

21457 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

21457

Product Number

1

Dosage Form

-

Strength

EQ 0.09MG BASE/INH

Approval Date

2004-10-29

Regulatory Status

RX

2015
31 Mar
RX Application: 205636

Drug Name

PROAIR RESPICLICK

Product Number

1

Dosage Form

-

Strength

EQ 0.09MG BASE/INH

Approval Date

2015-03-31

205636 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

205636

Product Number

1

Dosage Form

-

Strength

EQ 0.09MG BASE/INH

Approval Date

2015-03-31

Regulatory Status

RX

1996
11 Jul
Discontinued Application: 40120

Drug Name

PROCHLORPERAZINE MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1996-07-11

40120 / 1

Active Ingredient

PROCHLORPERAZINE MALEATE

Application Number

40120

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1996-07-11

Regulatory Status

Discontinued

1996
11 Jul
Discontinued Application: 40120

Drug Name

PROCHLORPERAZINE MALEATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1996-07-11

40120 / 2

Active Ingredient

PROCHLORPERAZINE MALEATE

Application Number

40120

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1996-07-11

Regulatory Status

Discontinued

2012
29 Feb
Discontinued Application: 202121

Drug Name

PROGESTERONE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2012-02-29

202121 / 1

Active Ingredient

PROGESTERONE

Application Number

202121

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2012-02-29

Regulatory Status

Discontinued

2012
29 Feb
Discontinued Application: 202121

Drug Name

PROGESTERONE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2012-02-29

202121 / 2

Active Ingredient

PROGESTERONE

Application Number

202121

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2012-02-29

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17425

Drug Name

PROGLYCEM

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

17425 / 1

Active Ingredient

DIAZOXIDE

Application Number

17425

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17425

Drug Name

PROGLYCEM

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

17425 / 2

Active Ingredient

DIAZOXIDE

Application Number

17425

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 17453

Drug Name

PROGLYCEM

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

17453 / 1

Active Ingredient

DIAZOXIDE

Application Number

17453

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

2002
22 Aug
Discontinued Application: 40454

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-08-22

40454 / 1

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40454

Product Number

1

Dosage Form

-

Strength

25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-08-22

Regulatory Status

Discontinued

2002
22 Aug
Discontinued Application: 40454

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-08-22

40454 / 2

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40454

Product Number

2

Dosage Form

-

Strength

50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-08-22

Regulatory Status

Discontinued

2021
13 Aug
RX Application: 215506

Drug Name

PYRIMETHAMINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2021-08-13

215506 / 1

Active Ingredient

PYRIMETHAMINE

Application Number

215506

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2021-08-13

Regulatory Status

RX

2012
23 Mar
RX Application: 202813

Drug Name

QNASL

Product Number

1

Dosage Form

-

Strength

0.08MG/ACTUATION

Approval Date

2012-03-23

202813 / 1

Active Ingredient

BECLOMETHASONE DIPROPIONATE

Application Number

202813

Product Number

1

Dosage Form

-

Strength

0.08MG/ACTUATION

Approval Date

2012-03-23

Regulatory Status

RX

2014
17 Dec
RX Application: 202813

Drug Name

QNASL

Product Number

2

Dosage Form

-

Strength

0.04MG/ACTUATION

Approval Date

2014-12-17

202813 / 2

Active Ingredient

BECLOMETHASONE DIPROPIONATE

Application Number

202813

Product Number

2

Dosage Form

-

Strength

0.04MG/ACTUATION

Approval Date

2014-12-17

Regulatory Status

RX

2013
28 Mar
RX Application: 204061

Drug Name

QUARTETTE

Product Number

1

Dosage Form

-

Strength

0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A

Approval Date

2013-03-28

204061 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

204061

Product Number

1

Dosage Form

-

Strength

0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A

Approval Date

2013-03-28

Regulatory Status

RX

2012
27 Mar
RX Application: 77745

Drug Name

QUETIAPINE FUMARATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2012-03-27

77745 / 1

Active Ingredient

QUETIAPINE FUMARATE

Application Number

77745

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2012-03-27

Regulatory Status

RX

2012
27 Mar
RX Application: 77745

Drug Name

QUETIAPINE FUMARATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2012-03-27

77745 / 2

Active Ingredient

QUETIAPINE FUMARATE

Application Number

77745

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2012-03-27

Regulatory Status

RX

2012
27 Mar
RX Application: 77745

Drug Name

QUETIAPINE FUMARATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2012-03-27

77745 / 3

Active Ingredient

QUETIAPINE FUMARATE

Application Number

77745

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2012-03-27

Regulatory Status

RX

2012
27 Mar
RX Application: 77745

Drug Name

QUETIAPINE FUMARATE

Product Number

4

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2012-03-27

77745 / 4

Active Ingredient

QUETIAPINE FUMARATE

Application Number

77745

Product Number

4

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2012-03-27

Regulatory Status

RX

2012
27 Mar
RX Application: 77745

Drug Name

QUETIAPINE FUMARATE

Product Number

5

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2012-03-27

77745 / 5

Active Ingredient

QUETIAPINE FUMARATE

Application Number

77745

Product Number

5

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2012-03-27

Regulatory Status

RX

2012
27 Mar
RX Application: 77745

Drug Name

QUETIAPINE FUMARATE

Product Number

6

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2012-03-27

77745 / 6

Active Ingredient

QUETIAPINE FUMARATE

Application Number

77745

Product Number

6

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2012-03-27

Regulatory Status

RX

2012
27 Mar
RX Application: 77745

Drug Name

QUETIAPINE FUMARATE

Product Number

7

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2012-03-27

77745 / 7

Active Ingredient

QUETIAPINE FUMARATE

Application Number

77745

Product Number

7

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2012-03-27

Regulatory Status

RX

2012
28 Sep
RX Application: 91661

Drug Name

QUININE SULFATE

Product Number

1

Dosage Form

-

Strength

324MG

Approval Date

2012-09-28

91661 / 1

Active Ingredient

QUININE SULFATE

Application Number

91661

Product Number

1

Dosage Form

-

Strength

324MG

Approval Date

2012-09-28

Regulatory Status

RX

2000
15 Sep
Discontinued Application: 20911

Drug Name

QVAR 40

Product Number

2

Dosage Form

-

Strength

0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-09-15

20911 / 2

Active Ingredient

BECLOMETHASONE DIPROPIONATE

Application Number

20911

Product Number

2

Dosage Form

-

Strength

0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-09-15

Regulatory Status

Discontinued

2000
15 Sep
Discontinued Application: 20911

Drug Name

QVAR 80

Product Number

1

Dosage Form

-

Strength

0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-09-15

20911 / 1

Active Ingredient

BECLOMETHASONE DIPROPIONATE

Application Number

20911

Product Number

1

Dosage Form

-

Strength

0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-09-15

Regulatory Status

Discontinued

2013
08 Nov
Discontinued Application: 76822

Drug Name

RABEPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2013-11-08

76822 / 1

Active Ingredient

RABEPRAZOLE SODIUM

Application Number

76822

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2013-11-08

Regulatory Status

Discontinued

2014
04 Mar
RX Application: 78193

Drug Name

RALOXIFENE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2014-03-04

78193 / 1

Active Ingredient

RALOXIFENE HYDROCHLORIDE

Application Number

78193

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2014-03-04

Regulatory Status

RX

2008
18 Jun
Discontinued Application: 77470

Drug Name

RAMIPRIL

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

2008-06-18

77470 / 1

Active Ingredient

RAMIPRIL

Application Number

77470

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

2008-06-18

Regulatory Status

Discontinued

2008
18 Jun
Discontinued Application: 77470

Drug Name

RAMIPRIL

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2008-06-18

77470 / 2

Active Ingredient

RAMIPRIL

Application Number

77470

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2008-06-18

Regulatory Status

Discontinued

2008
18 Jun
Discontinued Application: 77470

Drug Name

RAMIPRIL

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2008-06-18

77470 / 3

Active Ingredient

RAMIPRIL

Application Number

77470

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2008-06-18

Regulatory Status

Discontinued

2008
18 Jun
Discontinued Application: 77470

Drug Name

RAMIPRIL

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2008-06-18

77470 / 4

Active Ingredient

RAMIPRIL

Application Number

77470

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2008-06-18

Regulatory Status

Discontinued

-
Unclassified Application: 208174

Drug Name

RANOLAZINE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

-

208174 / 1

Active Ingredient

RANOLAZINE

Application Number

208174

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 208174

Drug Name

RANOLAZINE

Product Number

2

Dosage Form

-

Strength

1000MG

Approval Date

-

208174 / 2

Active Ingredient

RANOLAZINE

Application Number

208174

Product Number

2

Dosage Form

-

Strength

1000MG

Approval Date

-

Regulatory Status

Unclassified

1984
20 Nov
Discontinued Application: 18932

Drug Name

REVIA

Product Number

1

Dosage Form

-

Strength

50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-11-20

18932 / 1

Active Ingredient

NALTREXONE HYDROCHLORIDE

Application Number

18932

Product Number

1

Dosage Form

-

Strength

50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-11-20

Regulatory Status

Discontinued

-
Unclassified Application: 77611

Drug Name

RIBAVIRIN

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

-

77611 / 1

Active Ingredient

RIBAVIRIN

Application Number

77611

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 211044

Drug Name

RIOCIGUAT

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

-

211044 / 2

Active Ingredient

RIOCIGUAT

Application Number

211044

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 211044

Drug Name

RIOCIGUAT

Product Number

3

Dosage Form

-

Strength

1.5MG

Approval Date

-

211044 / 3

Active Ingredient

RIOCIGUAT

Application Number

211044

Product Number

3

Dosage Form

-

Strength

1.5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 211044

Drug Name

RIOCIGUAT

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

-

211044 / 4

Active Ingredient

RIOCIGUAT

Application Number

211044

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 211044

Drug Name

RIOCIGUAT

Product Number

5

Dosage Form

-

Strength

2.5MG

Approval Date

-

211044 / 5

Active Ingredient

RIOCIGUAT

Application Number

211044

Product Number

5

Dosage Form

-

Strength

2.5MG

Approval Date

-

Regulatory Status

Unclassified

2007
05 Oct
RX Application: 77132

Drug Name

RISEDRONATE SODIUM

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-10-05

77132 / 1

Active Ingredient

RISEDRONATE SODIUM

Application Number

77132

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-10-05

Regulatory Status

RX

2007
05 Oct
RX Application: 77132

Drug Name

RISEDRONATE SODIUM

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2007-10-05

77132 / 2

Active Ingredient

RISEDRONATE SODIUM

Application Number

77132

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2007-10-05

Regulatory Status

RX

2007
05 Oct
RX Application: 77132

Drug Name

RISEDRONATE SODIUM

Product Number

3

Dosage Form

-

Strength

35MG

Approval Date

2007-10-05

77132 / 3

Active Ingredient

RISEDRONATE SODIUM

Application Number

77132

Product Number

3

Dosage Form

-

Strength

35MG

Approval Date

2007-10-05

Regulatory Status

RX

2014
13 Jun
RX Application: 79215

Drug Name

RISEDRONATE SODIUM

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2014-06-13

79215 / 1

Active Ingredient

RISEDRONATE SODIUM

Application Number

79215

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2014-06-13

Regulatory Status

RX

2015
18 May
RX Application: 203217

Drug Name

RISEDRONATE SODIUM

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

2015-05-18

203217 / 1

Active Ingredient

RISEDRONATE SODIUM

Application Number

203217

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

2015-05-18

Regulatory Status

RX

2023
05 Dec
RX Application: 214068

Drug Name

RISPERIDONE

Product Number

1

Dosage Form

-

Strength

12.5MG/VIAL

Approval Date

2023-12-05

214068 / 1

Active Ingredient

RISPERIDONE

Application Number

214068

Product Number

1

Dosage Form

-

Strength

12.5MG/VIAL

Approval Date

2023-12-05

Regulatory Status

RX

2023
05 Dec
RX Application: 214068

Drug Name

RISPERIDONE

Product Number

2

Dosage Form

-

Strength

25MG/VIAL

Approval Date

2023-12-05

214068 / 2

Active Ingredient

RISPERIDONE

Application Number

214068

Product Number

2

Dosage Form

-

Strength

25MG/VIAL

Approval Date

2023-12-05

Regulatory Status

RX

2023
05 Dec
RX Application: 214068

Drug Name

RISPERIDONE

Product Number

3

Dosage Form

-

Strength

37.5MG/VIAL

Approval Date

2023-12-05

214068 / 3

Active Ingredient

RISPERIDONE

Application Number

214068

Product Number

3

Dosage Form

-

Strength

37.5MG/VIAL

Approval Date

2023-12-05

Regulatory Status

RX

2023
05 Dec
RX Application: 214068

Drug Name

RISPERIDONE

Product Number

4

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2023-12-05

214068 / 4

Active Ingredient

RISPERIDONE

Application Number

214068

Product Number

4

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2023-12-05

Regulatory Status

RX

2012
31 Dec
RX Application: 77263

Drug Name

RIZATRIPTAN BENZOATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-12-31

77263 / 1

Active Ingredient

RIZATRIPTAN BENZOATE

Application Number

77263

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-12-31

Regulatory Status

RX

2012
31 Dec
RX Application: 77263

Drug Name

RIZATRIPTAN BENZOATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-12-31

77263 / 2

Active Ingredient

RIZATRIPTAN BENZOATE

Application Number

77263

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-12-31

Regulatory Status

RX

2008
26 Nov
Discontinued Application: 78717

Drug Name

ROCURONIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2008-11-26

78717 / 1

Active Ingredient

ROCURONIUM BROMIDE

Application Number

78717

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2008-11-26

Regulatory Status

Discontinued

2008
26 Nov
Discontinued Application: 78717

Drug Name

ROCURONIUM BROMIDE

Product Number

2

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2008-11-26

78717 / 2

Active Ingredient

ROCURONIUM BROMIDE

Application Number

78717

Product Number

2

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2008-11-26

Regulatory Status

Discontinued

2020
13 Mar
Discontinued Application: 208574

Drug Name

ROMIDEPSIN

Product Number

1

Dosage Form

-

Strength

10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2020-03-13

208574 / 1

Active Ingredient

ROMIDEPSIN

Application Number

208574

Product Number

1

Dosage Form

-

Strength

10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2020-03-13

Regulatory Status

Discontinued

2020
13 Mar
Discontinued Application: 208574

Drug Name

ROMIDEPSIN

Product Number

2

Dosage Form

-

Strength

27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2020-03-13

208574 / 2

Active Ingredient

ROMIDEPSIN

Application Number

208574

Product Number

2

Dosage Form

-

Strength

27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2020-03-13

Regulatory Status

Discontinued

2016
01 Apr
Discontinued Application: 78709

Drug Name

ROSIGLITAZONE MALEATE AND GLIMEPIRIDE

Product Number

1

Dosage Form

-

Strength

1MG;4MG

Approval Date

2016-04-01

78709 / 1

Active Ingredient

GLIMEPIRIDE; ROSIGLITAZONE MALEATE

Application Number

78709

Product Number

1

Dosage Form

-

Strength

1MG;4MG

Approval Date

2016-04-01

Regulatory Status

Discontinued

2016
01 Apr
Discontinued Application: 78709

Drug Name

ROSIGLITAZONE MALEATE AND GLIMEPIRIDE

Product Number

2

Dosage Form

-

Strength

2MG;4MG

Approval Date

2016-04-01

78709 / 2

Active Ingredient

GLIMEPIRIDE; ROSIGLITAZONE MALEATE

Application Number

78709

Product Number

2

Dosage Form

-

Strength

2MG;4MG

Approval Date

2016-04-01

Regulatory Status

Discontinued

2016
01 Apr
Discontinued Application: 78709

Drug Name

ROSIGLITAZONE MALEATE AND GLIMEPIRIDE

Product Number

3

Dosage Form

-

Strength

4MG;4MG

Approval Date

2016-04-01

78709 / 3

Active Ingredient

GLIMEPIRIDE; ROSIGLITAZONE MALEATE

Application Number

78709

Product Number

3

Dosage Form

-

Strength

4MG;4MG

Approval Date

2016-04-01

Regulatory Status

Discontinued

2016
01 Apr
Discontinued Application: 78709

Drug Name

ROSIGLITAZONE MALEATE AND GLIMEPIRIDE

Product Number

4

Dosage Form

-

Strength

2MG;8MG

Approval Date

2016-04-01

78709 / 4

Active Ingredient

GLIMEPIRIDE; ROSIGLITAZONE MALEATE

Application Number

78709

Product Number

4

Dosage Form

-

Strength

2MG;8MG

Approval Date

2016-04-01

Regulatory Status

Discontinued

2016
01 Apr
Discontinued Application: 78709

Drug Name

ROSIGLITAZONE MALEATE AND GLIMEPIRIDE

Product Number

5

Dosage Form

-

Strength

4MG;8MG

Approval Date

2016-04-01

78709 / 5

Active Ingredient

GLIMEPIRIDE; ROSIGLITAZONE MALEATE

Application Number

78709

Product Number

5

Dosage Form

-

Strength

4MG;8MG

Approval Date

2016-04-01

Regulatory Status

Discontinued

2016
19 Jul
Discontinued Application: 79166

Drug Name

ROSUVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2016-07-19

79166 / 1

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79166

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2016-07-19

Regulatory Status

Discontinued

2016
19 Jul
Discontinued Application: 79166

Drug Name

ROSUVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-07-19

79166 / 2

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79166

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-07-19

Regulatory Status

Discontinued

2016
19 Jul
Discontinued Application: 79166

Drug Name

ROSUVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2016-07-19

79166 / 3

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79166

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2016-07-19

Regulatory Status

Discontinued

2016
19 Jul
Discontinued Application: 79166

Drug Name

ROSUVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2016-07-19

79166 / 4

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79166

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2016-07-19

Regulatory Status

Discontinued

2003
05 Sep
RX Application: 21544

Drug Name

SEASONALE

Product Number

1

Dosage Form

-

Strength

0.03MG;0.15MG

Approval Date

2003-09-05

21544 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

21544

Product Number

1

Dosage Form

-

Strength

0.03MG;0.15MG

Approval Date

2003-09-05

Regulatory Status

RX

2006
25 May
RX Application: 21840

Drug Name

SEASONIQUE

Product Number

1

Dosage Form

-

Strength

0.03MG,0.01MG;0.15MG,N/A

Approval Date

2006-05-25

21840 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

21840

Product Number

1

Dosage Form

-

Strength

0.03MG,0.01MG;0.15MG,N/A

Approval Date

2006-05-25

Regulatory Status

RX

2014
03 Feb
Discontinued Application: 200151

Drug Name

SELFEMRA

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2014-02-03

200151 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

200151

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2014-02-03

Regulatory Status

Discontinued

2014
03 Feb
Discontinued Application: 200151

Drug Name

SELFEMRA

Product Number

2

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2014-02-03

200151 / 2

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

200151

Product Number

2

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2014-02-03

Regulatory Status

Discontinued

2014
03 Feb
Discontinued Application: 200151

Drug Name

SELFEMRA

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2014-02-03

200151 / 3

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

200151

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2014-02-03

Regulatory Status

Discontinued

2013
07 Jan
Discontinued Application: 78380

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2013-01-07

78380 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

78380

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2013-01-07

Regulatory Status

Discontinued

2020
29 May
RX Application: 211534

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2020-05-29

211534 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

211534

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2020-05-29

Regulatory Status

RX

-
Unclassified Application: 76532

Drug Name

SIMVASTATIN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

-

76532 / 1

Active Ingredient

SIMVASTATIN

Application Number

76532

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 76532

Drug Name

SIMVASTATIN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

76532 / 2

Active Ingredient

SIMVASTATIN

Application Number

76532

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 76532

Drug Name

SIMVASTATIN

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

-

76532 / 3

Active Ingredient

SIMVASTATIN

Application Number

76532

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 76532

Drug Name

SIMVASTATIN

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

-

76532 / 4

Active Ingredient

SIMVASTATIN

Application Number

76532

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 76532

Drug Name

SIMVASTATIN

Product Number

5

Dosage Form

-

Strength

80MG

Approval Date

-

76532 / 5

Active Ingredient

SIMVASTATIN

Application Number

76532

Product Number

5

Dosage Form

-

Strength

80MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 202487

Drug Name

SITAGLIPTIN PHOSPHATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

-

202487 / 1

Active Ingredient

SITAGLIPTIN PHOSPHATE

Application Number

202487

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 202487

Drug Name

SITAGLIPTIN PHOSPHATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

-

202487 / 2

Active Ingredient

SITAGLIPTIN PHOSPHATE

Application Number

202487

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 202487

Drug Name

SITAGLIPTIN PHOSPHATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

-

202487 / 3

Active Ingredient

SITAGLIPTIN PHOSPHATE

Application Number

202487

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 204591

Drug Name

SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG;500MG

Approval Date

-

204591 / 1

Active Ingredient

SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE

Application Number

204591

Product Number

1

Dosage Form

-

Strength

50MG;500MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 204591

Drug Name

SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG;1000MG

Approval Date

-

204591 / 2

Active Ingredient

SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE

Application Number

204591

Product Number

2

Dosage Form

-

Strength

50MG;1000MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 204591

Drug Name

SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

100MG;1000MG

Approval Date

-

204591 / 3

Active Ingredient

SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE

Application Number

204591

Product Number

3

Dosage Form

-

Strength

100MG;1000MG

Approval Date

-

Regulatory Status

Unclassified

2022
27 Jan
Discontinued Application: 211353

Drug Name

SOFOSBUVIR

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2022-01-27

211353 / 1

Active Ingredient

SOFOSBUVIR

Application Number

211353

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2022-01-27

Regulatory Status

Discontinued

2014
02 Apr
RX Application: 91464

Drug Name

SOLIFENACIN SUCCINATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2014-04-02

91464 / 1

Active Ingredient

SOLIFENACIN SUCCINATE

Application Number

91464

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2014-04-02

Regulatory Status

RX

2014
02 Apr
RX Application: 91464

Drug Name

SOLIFENACIN SUCCINATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2014-04-02

91464 / 2

Active Ingredient

SOLIFENACIN SUCCINATE

Application Number

91464

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2014-04-02

Regulatory Status

RX

2020
12 Nov
RX Application: 209567

Drug Name

SORAFENIB TOSYLATE

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2020-11-12

209567 / 1

Active Ingredient

SORAFENIB TOSYLATE

Application Number

209567

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2020-11-12

Regulatory Status

RX

2026
28 Jul
RX Application: 214126

Drug Name

SUGAMMADEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/2ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

214126 / 1

Active Ingredient

SUGAMMADEX SODIUM

Application Number

214126

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/2ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

Regulatory Status

RX

2026
28 Jul
RX Application: 214126

Drug Name

SUGAMMADEX SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

214126 / 2

Active Ingredient

SUGAMMADEX SODIUM

Application Number

214126

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

Regulatory Status

RX

1991
31 Oct
RX Application: 73303

Drug Name

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Product Number

1

Dosage Form

-

Strength

80MG/ML;16MG/ML

Approval Date

1991-10-31

73303 / 1

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

73303

Product Number

1

Dosage Form

-

Strength

80MG/ML;16MG/ML

Approval Date

1991-10-31

Regulatory Status

RX

2009
06 Feb
Discontinued Application: 77907

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

Approval Date

2009-02-06

77907 / 1

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

77907

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

Approval Date

2009-02-06

Regulatory Status

Discontinued

2021
30 Nov
RX Application: 213803

Drug Name

SUNITINIB MALATE

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE

Approval Date

2021-11-30

213803 / 1

Active Ingredient

SUNITINIB MALATE

Application Number

213803

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE

Approval Date

2021-11-30

Regulatory Status

RX

2021
30 Nov
RX Application: 213803

Drug Name

SUNITINIB MALATE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2021-11-30

213803 / 2

Active Ingredient

SUNITINIB MALATE

Application Number

213803

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2021-11-30

Regulatory Status

RX

2021
30 Nov
RX Application: 213803

Drug Name

SUNITINIB MALATE

Product Number

3

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2021-11-30

213803 / 3

Active Ingredient

SUNITINIB MALATE

Application Number

213803

Product Number

3

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2021-11-30

Regulatory Status

RX

2021
30 Nov
RX Application: 213803

Drug Name

SUNITINIB MALATE

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2021-11-30

213803 / 4

Active Ingredient

SUNITINIB MALATE

Application Number

213803

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2021-11-30

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 16792

Drug Name

SURMONTIL

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

16792 / 1

Active Ingredient

TRIMIPRAMINE MALEATE

Application Number

16792

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16792

Drug Name

SURMONTIL

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

16792 / 2

Active Ingredient

TRIMIPRAMINE MALEATE

Application Number

16792

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
15 Sep
Discontinued Application: 16792

Drug Name

SURMONTIL

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-09-15

16792 / 3

Active Ingredient

TRIMIPRAMINE MALEATE

Application Number

16792

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-09-15

Regulatory Status

Discontinued

2008
28 Nov
Discontinued Application: 21788

Drug Name

SYNTHETIC CONJUGATED ESTROGENS A

Product Number

1

Dosage Form

-

Strength

0.625MG/GM

Approval Date

2008-11-28

21788 / 1

Active Ingredient

ESTROGENS, CONJUGATED SYNTHETIC A

Application Number

21788

Product Number

1

Dosage Form

-

Strength

0.625MG/GM

Approval Date

2008-11-28

Regulatory Status

Discontinued

2018
22 May
RX Application: 90141

Drug Name

TADALAFIL

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2018-05-22

90141 / 1

Active Ingredient

TADALAFIL

Application Number

90141

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2018-05-22

Regulatory Status

RX

2018
22 May
RX Application: 90141

Drug Name

TADALAFIL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2018-05-22

90141 / 2

Active Ingredient

TADALAFIL

Application Number

90141

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2018-05-22

Regulatory Status

RX

2018
22 May
RX Application: 90141

Drug Name

TADALAFIL

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2018-05-22

90141 / 3

Active Ingredient

TADALAFIL

Application Number

90141

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2018-05-22

Regulatory Status

RX

2018
22 May
RX Application: 90141

Drug Name

TADALAFIL

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2018-05-22

90141 / 4

Active Ingredient

TADALAFIL

Application Number

90141

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2018-05-22

Regulatory Status

RX

2010
27 Apr
RX Application: 77630

Drug Name

TAMSULOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.4MG

Approval Date

2010-04-27

77630 / 1

Active Ingredient

TAMSULOSIN HYDROCHLORIDE

Application Number

77630

Product Number

1

Dosage Form

-

Strength

0.4MG

Approval Date

2010-04-27

Regulatory Status

RX

2022
12 Dec
RX Application: 211601

Drug Name

TASIMELTEON

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2022-12-12

211601 / 1

Active Ingredient

TASIMELTEON

Application Number

211601

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2022-12-12

Regulatory Status

RX

2015
18 Mar
RX Application: 91612

Drug Name

TENOFOVIR DISOPROXIL FUMARATE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2015-03-18

91612 / 1

Active Ingredient

TENOFOVIR DISOPROXIL FUMARATE

Application Number

91612

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2015-03-18

Regulatory Status

RX

2018
26 Jan
RX Application: 91612

Drug Name

TENOFOVIR DISOPROXIL FUMARATE

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2018-01-26

91612 / 2

Active Ingredient

TENOFOVIR DISOPROXIL FUMARATE

Application Number

91612

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2018-01-26

Regulatory Status

RX

2018
26 Jan
RX Application: 91612

Drug Name

TENOFOVIR DISOPROXIL FUMARATE

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2018-01-26

91612 / 3

Active Ingredient

TENOFOVIR DISOPROXIL FUMARATE

Application Number

91612

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2018-01-26

Regulatory Status

RX

2018
26 Jan
RX Application: 91612

Drug Name

TENOFOVIR DISOPROXIL FUMARATE

Product Number

4

Dosage Form

-

Strength

250MG

Approval Date

2018-01-26

91612 / 4

Active Ingredient

TENOFOVIR DISOPROXIL FUMARATE

Application Number

91612

Product Number

4

Dosage Form

-

Strength

250MG

Approval Date

2018-01-26

Regulatory Status

RX

2018
04 Sep
RX Application: 209700

Drug Name

TERIFLUNOMIDE

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

2018-09-04

209700 / 1

Active Ingredient

TERIFLUNOMIDE

Application Number

209700

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

2018-09-04

Regulatory Status

RX

2018
04 Sep
RX Application: 209700

Drug Name

TERIFLUNOMIDE

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

2018-09-04

209700 / 2

Active Ingredient

TERIFLUNOMIDE

Application Number

209700

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

2018-09-04

Regulatory Status

RX

2023
16 Nov
RX Application: 208569

Drug Name

TERIPARATIDE

Product Number

1

Dosage Form

-

Strength

0.56MG/2.24ML (0.25MG/ML)

Approval Date

2023-11-16

208569 / 1

Active Ingredient

TERIPARATIDE

Application Number

208569

Product Number

1

Dosage Form

-

Strength

0.56MG/2.24ML (0.25MG/ML)

Approval Date

2023-11-16

Regulatory Status

RX

1987
16 Oct
Discontinued Application: 71554

Drug Name

THIOTHIXENE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1987-10-16

71554 / 1

Active Ingredient

THIOTHIXENE HYDROCHLORIDE

Application Number

71554

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1987-10-16

Regulatory Status

Discontinued

2021
26 Apr
RX Application: 214326

Drug Name

TIOPRONIN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2021-04-26

214326 / 1

Active Ingredient

TIOPRONIN

Application Number

214326

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2021-04-26

Regulatory Status

RX

2013
10 Oct
RX Application: 91589

Drug Name

TOBRAMYCIN

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2013-10-10

91589 / 1

Active Ingredient

TOBRAMYCIN

Application Number

91589

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2013-10-10

Regulatory Status

RX

2019
26 Jun
Discontinued Application: 210915

Drug Name

TOBRAMYCIN

Product Number

1

Dosage Form

-

Strength

300MG/4ML

Approval Date

2019-06-26

210915 / 1

Active Ingredient

TOBRAMYCIN

Application Number

210915

Product Number

1

Dosage Form

-

Strength

300MG/4ML

Approval Date

2019-06-26

Regulatory Status

Discontinued

1992
30 Jan
Discontinued Application: 63100

Drug Name

TOBRAMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1992-01-30

63100 / 1

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

63100

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1992-01-30

Regulatory Status

Discontinued

-
Unclassified Application: 209813

Drug Name

TOFACITINIB CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 11MG BASE

Approval Date

-

209813 / 1

Active Ingredient

TOFACITINIB CITRATE

Application Number

209813

Product Number

1

Dosage Form

-

Strength

EQ 11MG BASE

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 209813

Drug Name

TOFACITINIB CITRATE

Product Number

2

Dosage Form

-

Strength

EQ 22MG BASE

Approval Date

-

209813 / 2

Active Ingredient

TOFACITINIB CITRATE

Application Number

209813

Product Number

2

Dosage Form

-

Strength

EQ 22MG BASE

Approval Date

-

Regulatory Status

Unclassified

2016
22 Nov
RX Application: 79141

Drug Name

TOLTERODINE TARTRATE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2016-11-22

79141 / 1

Active Ingredient

TOLTERODINE TARTRATE

Application Number

79141

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2016-11-22

Regulatory Status

RX

2016
22 Nov
RX Application: 79141

Drug Name

TOLTERODINE TARTRATE

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2016-11-22

79141 / 2

Active Ingredient

TOLTERODINE TARTRATE

Application Number

79141

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2016-11-22

Regulatory Status

RX

2006
12 Dec
Discontinued Application: 77489

Drug Name

TRANDOLAPRIL

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2006-12-12

77489 / 1

Active Ingredient

TRANDOLAPRIL

Application Number

77489

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2006-12-12

Regulatory Status

Discontinued

2006
12 Dec
Discontinued Application: 77489

Drug Name

TRANDOLAPRIL

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2006-12-12

77489 / 2

Active Ingredient

TRANDOLAPRIL

Application Number

77489

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2006-12-12

Regulatory Status

Discontinued

2006
12 Dec
Discontinued Application: 77489

Drug Name

TRANDOLAPRIL

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2006-12-12

77489 / 3

Active Ingredient

TRANDOLAPRIL

Application Number

77489

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2006-12-12

Regulatory Status

Discontinued

1987
11 Dec
RX Application: 71523

Drug Name

TRAZODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1987-12-11

71523 / 1

Active Ingredient

TRAZODONE HYDROCHLORIDE

Application Number

71523

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1987-12-11

Regulatory Status

RX

1987
11 Dec
RX Application: 71524

Drug Name

TRAZODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1987-12-11

71524 / 1

Active Ingredient

TRAZODONE HYDROCHLORIDE

Application Number

71524

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1987-12-11

Regulatory Status

RX

2019
26 Sep
RX Application: 206648

Drug Name

TREPROSTINIL

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2019-09-26

206648 / 1

Active Ingredient

TREPROSTINIL

Application Number

206648

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2019-09-26

Regulatory Status

RX

2019
26 Sep
RX Application: 206648

Drug Name

TREPROSTINIL

Product Number

2

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2019-09-26

206648 / 2

Active Ingredient

TREPROSTINIL

Application Number

206648

Product Number

2

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2019-09-26

Regulatory Status

RX

2019
26 Sep
RX Application: 206648

Drug Name

TREPROSTINIL

Product Number

3

Dosage Form

-

Strength

5MG/ML

Approval Date

2019-09-26

206648 / 3

Active Ingredient

TREPROSTINIL

Application Number

206648

Product Number

3

Dosage Form

-

Strength

5MG/ML

Approval Date

2019-09-26

Regulatory Status

RX

2019
26 Sep
RX Application: 206648

Drug Name

TREPROSTINIL

Product Number

4

Dosage Form

-

Strength

10MG/ML

Approval Date

2019-09-26

206648 / 4

Active Ingredient

TREPROSTINIL

Application Number

206648

Product Number

4

Dosage Form

-

Strength

10MG/ML

Approval Date

2019-09-26

Regulatory Status

RX

1998
19 Jun
Discontinued Application: 74873

Drug Name

TRETINOIN

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1998-06-19

74873 / 1

Active Ingredient

TRETINOIN

Application Number

74873

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1998-06-19

Regulatory Status

Discontinued

2018
05 Oct
RX Application: 209852

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2018-10-05

209852 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

209852

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2018-10-05

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 6536

Drug Name

URECHOLINE

Product Number

1

Dosage Form

-

Strength

5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

6536 / 1

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

6536

Product Number

1

Dosage Form

-

Strength

5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 6536

Drug Name

URECHOLINE

Product Number

2

Dosage Form

-

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

6536 / 2

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

6536

Product Number

2

Dosage Form

-

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 6536

Drug Name

URECHOLINE

Product Number

3

Dosage Form

-

Strength

5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

6536 / 3

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

6536

Product Number

3

Dosage Form

-

Strength

5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 6536

Drug Name

URECHOLINE

Product Number

4

Dosage Form

-

Strength

25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

6536 / 4

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

6536

Product Number

4

Dosage Form

-

Strength

25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 6536

Drug Name

URECHOLINE

Product Number

5

Dosage Form

-

Strength

50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

6536 / 5

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

6536

Product Number

5

Dosage Form

-

Strength

50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

2000
25 May
Discontinued Application: 75592

Drug Name

URSODIOL

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2000-05-25

75592 / 1

Active Ingredient

URSODIOL

Application Number

75592

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2000-05-25

Regulatory Status

Discontinued

2009
13 May
Discontinued Application: 79184

Drug Name

URSODIOL

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2009-05-13

79184 / 1

Active Ingredient

URSODIOL

Application Number

79184

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2009-05-13

Regulatory Status

Discontinued

2009
13 May
Discontinued Application: 79184

Drug Name

URSODIOL

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2009-05-13

79184 / 2

Active Ingredient

URSODIOL

Application Number

79184

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2009-05-13

Regulatory Status

Discontinued

2010
24 May
Discontinued Application: 77655

Drug Name

VALACYCLOVIR HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2010-05-24

77655 / 1

Active Ingredient

VALACYCLOVIR HYDROCHLORIDE

Application Number

77655

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2010-05-24

Regulatory Status

Discontinued

2010
24 May
Discontinued Application: 77655

Drug Name

VALACYCLOVIR HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2010-05-24

77655 / 2

Active Ingredient

VALACYCLOVIR HYDROCHLORIDE

Application Number

77655

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2010-05-24

Regulatory Status

Discontinued

2015
23 Dec
Discontinued Application: 201250

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5GM BASE/VIAL

Approval Date

2015-12-23

201250 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

201250

Product Number

1

Dosage Form

-

Strength

EQ 5GM BASE/VIAL

Approval Date

2015-12-23

Regulatory Status

Discontinued

2015
23 Dec
Discontinued Application: 201250

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2015-12-23

201250 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

201250

Product Number

2

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2015-12-23

Regulatory Status

Discontinued

2015
23 Dec
Discontinued Application: 201251

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2015-12-23

201251 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

201251

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2015-12-23

Regulatory Status

Discontinued

2015
23 Dec
Discontinued Application: 201251

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2015-12-23

201251 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

201251

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2015-12-23

Regulatory Status

Discontinued

2005
20 May
RX Application: 21806

Drug Name

VANDAZOLE

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

2005-05-20

21806 / 1

Active Ingredient

METRONIDAZOLE

Application Number

21806

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

2005-05-20

Regulatory Status

RX

2017
17 Jan
Discontinued Application: 207975

Drug Name

VANTRELA ER

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2017-01-17

207975 / 1

Active Ingredient

HYDROCODONE BITARTRATE

Application Number

207975

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2017-01-17

Regulatory Status

Discontinued

2017
17 Jan
Discontinued Application: 207975

Drug Name

VANTRELA ER

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2017-01-17

207975 / 2

Active Ingredient

HYDROCODONE BITARTRATE

Application Number

207975

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2017-01-17

Regulatory Status

Discontinued

2017
17 Jan
Discontinued Application: 207975

Drug Name

VANTRELA ER

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2017-01-17

207975 / 3

Active Ingredient

HYDROCODONE BITARTRATE

Application Number

207975

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2017-01-17

Regulatory Status

Discontinued

2017
17 Jan
Discontinued Application: 207975

Drug Name

VANTRELA ER

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

2017-01-17

207975 / 4

Active Ingredient

HYDROCODONE BITARTRATE

Application Number

207975

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

2017-01-17

Regulatory Status

Discontinued

2017
17 Jan
Discontinued Application: 207975

Drug Name

VANTRELA ER

Product Number

5

Dosage Form

-

Strength

90MG

Approval Date

2017-01-17

207975 / 5

Active Ingredient

HYDROCODONE BITARTRATE

Application Number

207975

Product Number

5

Dosage Form

-

Strength

90MG

Approval Date

2017-01-17

Regulatory Status

Discontinued

2012
03 May
RX Application: 91347

Drug Name

VARDENAFIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2012-05-03

91347 / 1

Active Ingredient

VARDENAFIL HYDROCHLORIDE

Application Number

91347

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2012-05-03

Regulatory Status

RX

2012
03 May
RX Application: 91347

Drug Name

VARDENAFIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-05-03

91347 / 2

Active Ingredient

VARDENAFIL HYDROCHLORIDE

Application Number

91347

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-05-03

Regulatory Status

RX

2012
03 May
RX Application: 91347

Drug Name

VARDENAFIL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-05-03

91347 / 3

Active Ingredient

VARDENAFIL HYDROCHLORIDE

Application Number

91347

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-05-03

Regulatory Status

RX

2012
03 May
RX Application: 91347

Drug Name

VARDENAFIL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-05-03

91347 / 4

Active Ingredient

VARDENAFIL HYDROCHLORIDE

Application Number

91347

Product Number

4

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-05-03

Regulatory Status

RX

-
Unclassified Application: 201920

Drug Name

VARENICLINE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

-

201920 / 1

Active Ingredient

VARENICLINE

Application Number

201920

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 201920

Drug Name

VARENICLINE

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

-

201920 / 2

Active Ingredient

VARENICLINE

Application Number

201920

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

-

Regulatory Status

Unclassified

2019
14 Jan
RX Application: 209822

Drug Name

VIGABATRIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2019-01-14

209822 / 1

Active Ingredient

VIGABATRIN

Application Number

209822

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2019-01-14

Regulatory Status

RX

2018
23 Apr
Discontinued Application: 209824

Drug Name

VIGABATRIN

Product Number

1

Dosage Form

-

Strength

500MG/PACKET

Approval Date

2018-04-23

209824 / 1

Active Ingredient

VIGABATRIN

Application Number

209824

Product Number

1

Dosage Form

-

Strength

500MG/PACKET

Approval Date

2018-04-23

Regulatory Status

Discontinued

2019
30 Sep
RX Application: 208212

Drug Name

VILAZODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2019-09-30

208212 / 1

Active Ingredient

VILAZODONE HYDROCHLORIDE

Application Number

208212

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2019-09-30

Regulatory Status

RX

2019
30 Sep
RX Application: 208212

Drug Name

VILAZODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2019-09-30

208212 / 2

Active Ingredient

VILAZODONE HYDROCHLORIDE

Application Number

208212

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2019-09-30

Regulatory Status

RX

2019
30 Sep
RX Application: 208212

Drug Name

VILAZODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2019-09-30

208212 / 3

Active Ingredient

VILAZODONE HYDROCHLORIDE

Application Number

208212

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2019-09-30

Regulatory Status

RX

1999
01 Sep
Discontinued Application: 75493

Drug Name

VINCRISTINE SULFATE PFS

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1999-09-01

75493 / 1

Active Ingredient

VINCRISTINE SULFATE

Application Number

75493

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1999-09-01

Regulatory Status

Discontinued

2003
03 Feb
Discontinued Application: 76028

Drug Name

VINORELBINE TARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2003-02-03

76028 / 1

Active Ingredient

VINORELBINE TARTRATE

Application Number

76028

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2003-02-03

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16012

Drug Name

VIVACTIL

Product Number

1

Dosage Form

-

Strength

5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

16012 / 1

Active Ingredient

PROTRIPTYLINE HYDROCHLORIDE

Application Number

16012

Product Number

1

Dosage Form

-

Strength

5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16012

Drug Name

VIVACTIL

Product Number

2

Dosage Form

-

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

16012 / 2

Active Ingredient

PROTRIPTYLINE HYDROCHLORIDE

Application Number

16012

Product Number

2

Dosage Form

-

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

2012
06 Apr
Discontinued Application: 91658

Drug Name

VORICONAZOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2012-04-06

91658 / 1

Active Ingredient

VORICONAZOLE

Application Number

91658

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2012-04-06

Regulatory Status

Discontinued

2012
06 Apr
Discontinued Application: 91658

Drug Name

VORICONAZOLE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2012-04-06

91658 / 2

Active Ingredient

VORICONAZOLE

Application Number

91658

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2012-04-06

Regulatory Status

Discontinued

2008
06 Jun
Discontinued Application: 77239

Drug Name

ZALEPLON

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-06-06

77239 / 1

Active Ingredient

ZALEPLON

Application Number

77239

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-06-06

Regulatory Status

Discontinued

2008
06 Jun
Discontinued Application: 77239

Drug Name

ZALEPLON

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-06-06

77239 / 2

Active Ingredient

ZALEPLON

Application Number

77239

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-06-06

Regulatory Status

Discontinued

1982
07 May
Discontinued Application: 50577

Drug Name

ZANOSAR

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1982-05-07

50577 / 1

Active Ingredient

STREPTOZOCIN

Application Number

50577

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1982-05-07

Regulatory Status

Discontinued

1992
31 Jul
Discontinued Application: 19982

Drug Name

ZEBETA

Product Number

1

Dosage Form

-

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-07-31

19982 / 1

Active Ingredient

BISOPROLOL FUMARATE

Application Number

19982

Product Number

1

Dosage Form

-

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-07-31

Regulatory Status

Discontinued

1992
31 Jul
Discontinued Application: 19982

Drug Name

ZEBETA

Product Number

2

Dosage Form

-

Strength

5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-07-31

19982 / 2

Active Ingredient

BISOPROLOL FUMARATE

Application Number

19982

Product Number

2

Dosage Form

-

Strength

5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-07-31

Regulatory Status

Discontinued

2013
17 Jan
Discontinued Application: 202278

Drug Name

ZECUITY

Product Number

1

Dosage Form

-

Strength

EQ 6.5MG BASE/4HR

Approval Date

2013-01-17

202278 / 1

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

202278

Product Number

1

Dosage Form

-

Strength

EQ 6.5MG BASE/4HR

Approval Date

2013-01-17

Regulatory Status

Discontinued

1993
26 Mar
RX Application: 20186

Drug Name

ZIAC

Product Number

1

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

1993-03-26

20186 / 1

Active Ingredient

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Application Number

20186

Product Number

1

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

1993-03-26

Regulatory Status

RX

1993
26 Mar
RX Application: 20186

Drug Name

ZIAC

Product Number

2

Dosage Form

-

Strength

10MG;6.25MG

Approval Date

1993-03-26

20186 / 2

Active Ingredient

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Application Number

20186

Product Number

2

Dosage Form

-

Strength

10MG;6.25MG

Approval Date

1993-03-26

Regulatory Status

RX

1993
26 Mar
RX Application: 20186

Drug Name

ZIAC

Product Number

3

Dosage Form

-

Strength

2.5MG;6.25MG

Approval Date

1993-03-26

20186 / 3

Active Ingredient

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Application Number

20186

Product Number

3

Dosage Form

-

Strength

2.5MG;6.25MG

Approval Date

1993-03-26

Regulatory Status

RX

2022
03 May
Discontinued Application: 211043

Drug Name

ZILEUTON

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2022-05-03

211043 / 1

Active Ingredient

ZILEUTON

Application Number

211043

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2022-05-03

Regulatory Status

Discontinued

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Drug Status Breakdown
831 total
  • Discontinued
  • RX
  • Unclassified
  • OTC
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

Explore important FDA approved drug information available in the records above.

Drug Name

ABACAVIR SULFATE AND LAMIVUDINE

Application Number

79246

Product Number

1

Active Ingredient

ABACAVIR SULFATE; LAMIVUDINE

Dosage Form

-

Strength

EQ 600MG BASE;300MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

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Searchable pharmaceutical data

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Organized FDA drug records

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