Teva Pharmaceutical Industries RX
FDA Approved Drugs

Teva Pharmaceutical Industries RX

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.

RX
  • Total Records 338
  • 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 RX

Country

Israel

Email

Social Profiles

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Company Snapshot

Teva Pharmaceutical Industries RX

5 Basel St., Petach Tikva Israel, 49131

Israel

www.tevapharm.com/ View on Map
FDA Approved Drug Records ( 338 records )
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
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

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

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

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

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
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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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
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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Drug Status Breakdown
338 total
  • RX
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

ACITRETIN

Application Number

202897

Product Number

1

Active Ingredient

ACITRETIN

Dosage Form

-

Strength

17.5MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

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