Impax Laboratories
FDA Approved Drugs

Impax Laboratories

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 Discontinued Unclassified
  • Total Records 283
  • Latest Approval Date Jun 28, 2022
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
283
View
Unclassified
10
View
Discontinued
160
View
RX
113
View
Company Overview

Company

Impax Laboratories

Country

U.S.A

Social Profiles

Company Snapshot

Impax Laboratories

30831 Huntwood Ave.Hayward, CA 94544

U.S.A

www.impaxlabs.com/ inquiries@impaxlabs.com View on Map
FDA Approved Drug Records ( 283 records )
2009
14 May
RX Application: 78441

Drug Name

ACARBOSE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-05-14

78441 / 1

Active Ingredient

ACARBOSE

Application Number

78441

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-05-14

Regulatory Status

RX

2009
14 May
RX Application: 78441

Drug Name

ACARBOSE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-05-14

78441 / 2

Active Ingredient

ACARBOSE

Application Number

78441

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-05-14

Regulatory Status

RX

2009
14 May
RX Application: 78441

Drug Name

ACARBOSE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-05-14

78441 / 3

Active Ingredient

ACARBOSE

Application Number

78441

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-05-14

Regulatory Status

RX

2015
23 Dec
RX Application: 202552

Drug Name

ACITRETIN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2015-12-23

202552 / 1

Active Ingredient

ACITRETIN

Application Number

202552

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2015-12-23

Regulatory Status

RX

2015
23 Dec
RX Application: 202552

Drug Name

ACITRETIN

Product Number

2

Dosage Form

-

Strength

17.5MG

Approval Date

2015-12-23

202552 / 2

Active Ingredient

ACITRETIN

Application Number

202552

Product Number

2

Dosage Form

-

Strength

17.5MG

Approval Date

2015-12-23

Regulatory Status

RX

2015
23 Dec
RX Application: 202552

Drug Name

ACITRETIN

Product Number

3

Dosage Form

-

Strength

22.5MG

Approval Date

2015-12-23

202552 / 3

Active Ingredient

ACITRETIN

Application Number

202552

Product Number

3

Dosage Form

-

Strength

22.5MG

Approval Date

2015-12-23

Regulatory Status

RX

2015
23 Dec
RX Application: 202552

Drug Name

ACITRETIN

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2015-12-23

202552 / 4

Active Ingredient

ACITRETIN

Application Number

202552

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2015-12-23

Regulatory Status

RX

1996
11 Jun
Discontinued Application: 20666

Drug Name

ALBENZA

Product Number

1

Dosage Form

-

Strength

200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-06-11

20666 / 1

Active Ingredient

ALBENDAZOLE

Application Number

20666

Product Number

1

Dosage Form

-

Strength

200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-06-11

Regulatory Status

Discontinued

2008
06 Feb
Discontinued Application: 75710

Drug Name

ALENDRONATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2008-02-06

75710 / 1

Active Ingredient

ALENDRONATE SODIUM

Application Number

75710

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2008-02-06

Regulatory Status

Discontinued

2008
06 Feb
Discontinued Application: 75710

Drug Name

ALENDRONATE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2008-02-06

75710 / 2

Active Ingredient

ALENDRONATE SODIUM

Application Number

75710

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2008-02-06

Regulatory Status

Discontinued

2008
06 Feb
Discontinued Application: 75710

Drug Name

ALENDRONATE SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 35MG BASE

Approval Date

2008-02-06

75710 / 3

Active Ingredient

ALENDRONATE SODIUM

Application Number

75710

Product Number

3

Dosage Form

-

Strength

EQ 35MG BASE

Approval Date

2008-02-06

Regulatory Status

Discontinued

2008
06 Feb
Discontinued Application: 75710

Drug Name

ALENDRONATE SODIUM

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2008-02-06

75710 / 4

Active Ingredient

ALENDRONATE SODIUM

Application Number

75710

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2008-02-06

Regulatory Status

Discontinued

2008
06 Feb
Discontinued Application: 75710

Drug Name

ALENDRONATE SODIUM

Product Number

5

Dosage Form

-

Strength

EQ 70MG BASE

Approval Date

2008-02-06

75710 / 5

Active Ingredient

ALENDRONATE SODIUM

Application Number

75710

Product Number

5

Dosage Form

-

Strength

EQ 70MG BASE

Approval Date

2008-02-06

Regulatory Status

Discontinued

2007
24 May
Discontinued Application: 77968

Drug Name

ALPRAZOLAM

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2007-05-24

77968 / 1

Active Ingredient

ALPRAZOLAM

Application Number

77968

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2007-05-24

Regulatory Status

Discontinued

2007
24 May
Discontinued Application: 77968

Drug Name

ALPRAZOLAM

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2007-05-24

77968 / 2

Active Ingredient

ALPRAZOLAM

Application Number

77968

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2007-05-24

Regulatory Status

Discontinued

2007
24 May
Discontinued Application: 77968

Drug Name

ALPRAZOLAM

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2007-05-24

77968 / 3

Active Ingredient

ALPRAZOLAM

Application Number

77968

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2007-05-24

Regulatory Status

Discontinued

2007
24 May
Discontinued Application: 77968

Drug Name

ALPRAZOLAM

Product Number

4

Dosage Form

-

Strength

0.5MG

Approval Date

2007-05-24

77968 / 4

Active Ingredient

ALPRAZOLAM

Application Number

77968

Product Number

4

Dosage Form

-

Strength

0.5MG

Approval Date

2007-05-24

Regulatory Status

Discontinued

2007
31 Jan
Discontinued Application: 77996

Drug Name

ALPRAZOLAM

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2007-01-31

77996 / 1

Active Ingredient

ALPRAZOLAM

Application Number

77996

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2007-01-31

Regulatory Status

Discontinued

2007
31 Jan
Discontinued Application: 77996

Drug Name

ALPRAZOLAM

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2007-01-31

77996 / 2

Active Ingredient

ALPRAZOLAM

Application Number

77996

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2007-01-31

Regulatory Status

Discontinued

2007
31 Jan
Discontinued Application: 77996

Drug Name

ALPRAZOLAM

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2007-01-31

77996 / 3

Active Ingredient

ALPRAZOLAM

Application Number

77996

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2007-01-31

Regulatory Status

Discontinued

2007
31 Jan
Discontinued Application: 77996

Drug Name

ALPRAZOLAM

Product Number

4

Dosage Form

-

Strength

3MG

Approval Date

2007-01-31

77996 / 4

Active Ingredient

ALPRAZOLAM

Application Number

77996

Product Number

4

Dosage Form

-

Strength

3MG

Approval Date

2007-01-31

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84574

Drug Name

AMINOPHYLLINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

84574 / 1

Active Ingredient

AMINOPHYLLINE

Application Number

84574

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84575

Drug Name

AMINOPHYLLINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

84575 / 1

Active Ingredient

AMINOPHYLLINE

Application Number

84575

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84576

Drug Name

AMINOPHYLLINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

84576 / 1

Active Ingredient

AMINOPHYLLINE

Application Number

84576

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84577

Drug Name

AMINOPHYLLINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

84577 / 1

Active Ingredient

AMINOPHYLLINE

Application Number

84577

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2005
18 Apr
RX Application: 76910

Drug Name

ANAGRELIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2005-04-18

76910 / 1

Active Ingredient

ANAGRELIDE HYDROCHLORIDE

Application Number

76910

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2005-04-18

Regulatory Status

RX

2005
18 Apr
RX Application: 76910

Drug Name

ANAGRELIDE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2005-04-18

76910 / 2

Active Ingredient

ANAGRELIDE HYDROCHLORIDE

Application Number

76910

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2005-04-18

Regulatory Status

RX

2012
31 May
Discontinued Application: 91242

Drug Name

ANASTROZOLE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2012-05-31

91242 / 1

Active Ingredient

ANASTROZOLE

Application Number

91242

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2012-05-31

Regulatory Status

Discontinued

2008
18 Nov
Discontinued Application: 40845

Drug Name

BENZPHETAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2008-11-18

40845 / 1

Active Ingredient

BENZPHETAMINE HYDROCHLORIDE

Application Number

40845

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2008-11-18

Regulatory Status

Discontinued

2006
01 Nov
Discontinued Application: 40721

Drug Name

BETHANECHOL CHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-11-01

40721 / 1

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

40721

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-11-01

Regulatory Status

Discontinued

2006
01 Nov
Discontinued Application: 40721

Drug Name

BETHANECHOL CHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2006-11-01

40721 / 2

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

40721

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2006-11-01

Regulatory Status

Discontinued

2006
01 Nov
Discontinued Application: 40721

Drug Name

BETHANECHOL CHLORIDE

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2006-11-01

40721 / 3

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

40721

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2006-11-01

Regulatory Status

Discontinued

2006
01 Nov
Discontinued Application: 40721

Drug Name

BETHANECHOL CHLORIDE

Product Number

4

Dosage Form

-

Strength

50MG

Approval Date

2006-11-01

40721 / 4

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

40721

Product Number

4

Dosage Form

-

Strength

50MG

Approval Date

2006-11-01

Regulatory Status

Discontinued

2012
31 Jul
RX Application: 78404

Drug Name

BUDESONIDE

Product Number

1

Dosage Form

-

Strength

0.25MG/2ML

Approval Date

2012-07-31

78404 / 1

Active Ingredient

BUDESONIDE

Application Number

78404

Product Number

1

Dosage Form

-

Strength

0.25MG/2ML

Approval Date

2012-07-31

Regulatory Status

RX

2012
31 Jul
RX Application: 78404

Drug Name

BUDESONIDE

Product Number

2

Dosage Form

-

Strength

0.5MG/2ML

Approval Date

2012-07-31

78404 / 2

Active Ingredient

BUDESONIDE

Application Number

78404

Product Number

2

Dosage Form

-

Strength

0.5MG/2ML

Approval Date

2012-07-31

Regulatory Status

RX

2004
28 Jan
RX Application: 75913

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2004-01-28

75913 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

75913

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2004-01-28

Regulatory Status

RX

2004
22 Mar
RX Application: 75913

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2004-03-22

75913 / 2

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

75913

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2004-03-22

Regulatory Status

RX

2004
27 May
RX Application: 75914

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2004-05-27

75914 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

75914

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2004-05-27

Regulatory Status

RX

2004
03 Dec
Discontinued Application: 76711

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2004-12-03

76711 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

76711

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2004-12-03

Regulatory Status

Discontinued

2008
26 Nov
Discontinued Application: 77415

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2008-11-26

77415 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

77415

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2008-11-26

Regulatory Status

Discontinued

2006
15 Dec
Discontinued Application: 77415

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2006-12-15

77415 / 2

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

77415

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2006-12-15

Regulatory Status

Discontinued

2001
28 Mar
RX Application: 74253

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2001-03-28

74253 / 1

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

74253

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2001-03-28

Regulatory Status

RX

2001
28 Mar
RX Application: 74253

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2001-03-28

74253 / 2

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

74253

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2001-03-28

Regulatory Status

RX

2002
13 Mar
RX Application: 74253

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2002-03-13

74253 / 3

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

74253

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2002-03-13

Regulatory Status

RX

2007
03 Jul
Discontinued Application: 77843

Drug Name

CABERGOLINE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2007-07-03

77843 / 1

Active Ingredient

CABERGOLINE

Application Number

77843

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2007-07-03

Regulatory Status

Discontinued

2004
14 May
RX Application: 76521

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

1

Dosage Form

-

Strength

25MG;100MG

Approval Date

2004-05-14

76521 / 1

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

76521

Product Number

1

Dosage Form

-

Strength

25MG;100MG

Approval Date

2004-05-14

Regulatory Status

RX

2004
14 May
RX Application: 76521

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

2

Dosage Form

-

Strength

50MG;200MG

Approval Date

2004-05-14

76521 / 2

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

76521

Product Number

2

Dosage Form

-

Strength

50MG;200MG

Approval Date

2004-05-14

Regulatory Status

RX

2010
08 Jun
Discontinued Application: 90631

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

1

Dosage Form

-

Strength

10MG;100MG

Approval Date

2010-06-08

90631 / 1

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

90631

Product Number

1

Dosage Form

-

Strength

10MG;100MG

Approval Date

2010-06-08

Regulatory Status

Discontinued

2010
08 Jun
Discontinued Application: 90631

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

2

Dosage Form

-

Strength

25MG;100MG

Approval Date

2010-06-08

90631 / 2

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

90631

Product Number

2

Dosage Form

-

Strength

25MG;100MG

Approval Date

2010-06-08

Regulatory Status

Discontinued

2010
08 Jun
Discontinued Application: 90631

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

3

Dosage Form

-

Strength

25MG;250MG

Approval Date

2010-06-08

90631 / 3

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

90631

Product Number

3

Dosage Form

-

Strength

25MG;250MG

Approval Date

2010-06-08

Regulatory Status

Discontinued

2018
07 May
RX Application: 204717

Drug Name

CARVEDILOL PHOSPHATE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-05-07

204717 / 1

Active Ingredient

CARVEDILOL PHOSPHATE

Application Number

204717

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-05-07

Regulatory Status

RX

2018
07 May
RX Application: 204717

Drug Name

CARVEDILOL PHOSPHATE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-05-07

204717 / 2

Active Ingredient

CARVEDILOL PHOSPHATE

Application Number

204717

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-05-07

Regulatory Status

RX

2018
07 May
RX Application: 204717

Drug Name

CARVEDILOL PHOSPHATE

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2018-05-07

204717 / 3

Active Ingredient

CARVEDILOL PHOSPHATE

Application Number

204717

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2018-05-07

Regulatory Status

RX

2018
07 May
RX Application: 204717

Drug Name

CARVEDILOL PHOSPHATE

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2018-05-07

204717 / 4

Active Ingredient

CARVEDILOL PHOSPHATE

Application Number

204717

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2018-05-07

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 85113

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

85113 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

85113

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86212

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

86212 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

86212

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86213

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

86213 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

86213

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2003
29 Aug
RX Application: 40516

Drug Name

CHLOROQUINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2003-08-29

40516 / 1

Active Ingredient

CHLOROQUINE PHOSPHATE

Application Number

40516

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2003-08-29

Regulatory Status

RX

1982
01 Jan
RX Application: 80880

Drug Name

CHLOROQUINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

80880 / 1

Active Ingredient

CHLOROQUINE PHOSPHATE

Application Number

80880

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 80809

Drug Name

CHLORPHENIRAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

80809 / 1

Active Ingredient

CHLORPHENIRAMINE MALEATE

Application Number

80809

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2009
27 Aug
RX Application: 78099

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2009-08-27

78099 / 1

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

78099

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2009-08-27

Regulatory Status

RX

2009
27 Aug
RX Application: 78099

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2009-08-27

78099 / 2

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

78099

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2009-08-27

Regulatory Status

RX

2009
27 Aug
RX Application: 78099

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

0.3MG

Approval Date

2009-08-27

78099 / 3

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

78099

Product Number

3

Dosage Form

-

Strength

0.3MG

Approval Date

2009-08-27

Regulatory Status

RX

2018
16 May
RX Application: 91600

Drug Name

COLESEVELAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

625MG

Approval Date

2018-05-16

91600 / 1

Active Ingredient

COLESEVELAM HYDROCHLORIDE

Application Number

91600

Product Number

1

Dosage Form

-

Strength

625MG

Approval Date

2018-05-16

Regulatory Status

RX

2006
02 May
Discontinued Application: 77277

Drug Name

COLESTIPOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5GM/SCOOPFUL

Approval Date

2006-05-02

77277 / 1

Active Ingredient

COLESTIPOL HYDROCHLORIDE

Application Number

77277

Product Number

1

Dosage Form

-

Strength

5GM/SCOOPFUL

Approval Date

2006-05-02

Regulatory Status

Discontinued

2006
02 May
Discontinued Application: 77277

Drug Name

COLESTIPOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5GM/PACKET

Approval Date

2006-05-02

77277 / 2

Active Ingredient

COLESTIPOL HYDROCHLORIDE

Application Number

77277

Product Number

2

Dosage Form

-

Strength

5GM/PACKET

Approval Date

2006-05-02

Regulatory Status

Discontinued

2006
24 Oct
RX Application: 77510

Drug Name

COLESTIPOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2006-10-24

77510 / 1

Active Ingredient

COLESTIPOL HYDROCHLORIDE

Application Number

77510

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2006-10-24

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 9458

Drug Name

CORTISONE ACETATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Active Ingredient

CORTISONE ACETATE

Application Number

9458

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2005
01 Mar
RX Application: 76856

Drug Name

DANTROLENE SODIUM

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2005-03-01

76856 / 1

Active Ingredient

DANTROLENE SODIUM

Application Number

76856

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2005-03-01

Regulatory Status

RX

2005
01 Mar
RX Application: 76856

Drug Name

DANTROLENE SODIUM

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2005-03-01

76856 / 2

Active Ingredient

DANTROLENE SODIUM

Application Number

76856

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2005-03-01

Regulatory Status

RX

2005
01 Mar
RX Application: 76856

Drug Name

DANTROLENE SODIUM

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2005-03-01

76856 / 3

Active Ingredient

DANTROLENE SODIUM

Application Number

76856

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2005-03-01

Regulatory Status

RX

2004
22 Mar
Discontinued Application: 65094

Drug Name

DEMECLOCYCLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2004-03-22

65094 / 1

Active Ingredient

DEMECLOCYCLINE HYDROCHLORIDE

Application Number

65094

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2004-03-22

Regulatory Status

Discontinued

2004
22 Mar
Discontinued Application: 65094

Drug Name

DEMECLOCYCLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2004-03-22

65094 / 2

Active Ingredient

DEMECLOCYCLINE HYDROCHLORIDE

Application Number

65094

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2004-03-22

Regulatory Status

Discontinued

2006
25 Jan
Discontinued Application: 77122

Drug Name

DESMOPRESSIN ACETATE

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2006-01-25

77122 / 1

Active Ingredient

DESMOPRESSIN ACETATE

Application Number

77122

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2006-01-25

Regulatory Status

Discontinued

2006
25 Jan
Discontinued Application: 77122

Drug Name

DESMOPRESSIN ACETATE

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2006-01-25

77122 / 2

Active Ingredient

DESMOPRESSIN ACETATE

Application Number

77122

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2006-01-25

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85376

Drug Name

DEXAMETHASONE

Product Number

1

Dosage Form

-

Strength

0.75MG

Approval Date

1982-01-01

85376 / 1

Active Ingredient

DEXAMETHASONE

Application Number

85376

Product Number

1

Dosage Form

-

Strength

0.75MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 17078

Drug Name

DEXEDRINE SPANSULE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

17078 / 1

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

17078

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17078

Drug Name

DEXEDRINE SPANSULE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

17078 / 2

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

17078

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17078

Drug Name

DEXEDRINE SPANSULE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

17078 / 3

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

17078

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

Regulatory Status

RX

2015
05 Aug
RX Application: 79108

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-08-05

79108 / 1

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

79108

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-08-05

Regulatory Status

RX

2015
05 Aug
RX Application: 79108

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-08-05

79108 / 2

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

79108

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-08-05

Regulatory Status

RX

2014
19 May
RX Application: 79108

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2014-05-19

79108 / 3

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

79108

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2014-05-19

Regulatory Status

RX

2015
21 Dec
RX Application: 79108

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2015-12-21

79108 / 4

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

79108

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2015-12-21

Regulatory Status

RX

2013
21 Nov
RX Application: 79108

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2013-11-21

79108 / 5

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

79108

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2013-11-21

Regulatory Status

RX

2017
05 Jul
RX Application: 203614

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2017-07-05

203614 / 1

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

203614

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2017-07-05

Regulatory Status

RX

2017
05 Jul
RX Application: 203614

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

35MG

Approval Date

2017-07-05

203614 / 2

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

203614

Product Number

2

Dosage Form

-

Strength

35MG

Approval Date

2017-07-05

Regulatory Status

RX

2016
16 Feb
RX Application: 76852

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2016-02-16

76852 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

76852

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2016-02-16

Regulatory Status

RX

2016
16 Feb
RX Application: 76852

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

2

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2016-02-16

76852 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

76852

Product Number

2

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2016-02-16

Regulatory Status

RX

2016
16 Feb
RX Application: 76852

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

3

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2016-02-16

76852 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

76852

Product Number

3

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2016-02-16

Regulatory Status

RX

2016
16 Feb
RX Application: 76852

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

4

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2016-02-16

76852 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

76852

Product Number

4

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2016-02-16

Regulatory Status

RX

2016
16 Feb
RX Application: 76852

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

5

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2016-02-16

76852 / 5

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

76852

Product Number

5

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2016-02-16

Regulatory Status

RX

2016
16 Feb
RX Application: 76852

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

6

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2016-02-16

76852 / 6

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

76852

Product Number

6

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2016-02-16

Regulatory Status

RX

2009
20 Jul
Discontinued Application: 78556

Drug Name

DIGOXIN

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2009-07-20

78556 / 1

Active Ingredient

DIGOXIN

Application Number

78556

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2009-07-20

Regulatory Status

Discontinued

2009
20 Jul
Discontinued Application: 78556

Drug Name

DIGOXIN

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2009-07-20

78556 / 2

Active Ingredient

DIGOXIN

Application Number

78556

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2009-07-20

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80807

Drug Name

DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

80807 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

80807

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80807

Drug Name

DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

80807 / 2

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

80807

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2007
18 Jul
RX Application: 40782

Drug Name

DIPYRIDAMOLE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2007-07-18

40782 / 1

Active Ingredient

DIPYRIDAMOLE

Application Number

40782

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2007-07-18

Regulatory Status

RX

2007
18 Jul
RX Application: 40782

Drug Name

DIPYRIDAMOLE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2007-07-18

40782 / 2

Active Ingredient

DIPYRIDAMOLE

Application Number

40782

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2007-07-18

Regulatory Status

RX

2007
18 Jul
RX Application: 40782

Drug Name

DIPYRIDAMOLE

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2007-07-18

40782 / 3

Active Ingredient

DIPYRIDAMOLE

Application Number

40782

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2007-07-18

Regulatory Status

RX

2009
06 May
Discontinued Application: 78791

Drug Name

DIVALPROEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2009-05-06

78791 / 1

Active Ingredient

DIVALPROEX SODIUM

Application Number

78791

Product Number

1

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2009-05-06

Regulatory Status

Discontinued

2009
04 Aug
Discontinued Application: 78791

Drug Name

DIVALPROEX SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2009-08-04

78791 / 2

Active Ingredient

DIVALPROEX SODIUM

Application Number

78791

Product Number

2

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2009-08-04

Regulatory Status

Discontinued

2011
17 Feb
Discontinued Application: 200065

Drug Name

DOXYCYCLINE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2011-02-17

200065 / 1

Active Ingredient

DOXYCYCLINE

Application Number

200065

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2011-02-17

Regulatory Status

Discontinued

2010
28 Dec
Discontinued Application: 90505

Drug Name

DOXYCYCLINE HYCLATE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2010-12-28

90505 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

90505

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2010-12-28

Regulatory Status

Discontinued

2010
28 Dec
Discontinued Application: 90505

Drug Name

DOXYCYCLINE HYCLATE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2010-12-28

90505 / 2

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

90505

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2010-12-28

Regulatory Status

Discontinued

-
Unclassified Application: 90669

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

-

90669 / 1

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

90669

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 90669

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

-

90669 / 2

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

90669

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 90669

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

-

90669 / 3

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

90669

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

-

Regulatory Status

Unclassified

1995
04 Jan
RX Application: 73580

Drug Name

EMVERM

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1995-01-04

73580 / 1

Active Ingredient

MEBENDAZOLE

Application Number

73580

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1995-01-04

Regulatory Status

RX

2007
09 Aug
RX Application: 65331

Drug Name

EPIRUBICIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/25ML (2MG/ML)

Approval Date

2007-08-09

65331 / 1

Active Ingredient

EPIRUBICIN HYDROCHLORIDE

Application Number

65331

Product Number

1

Dosage Form

-

Strength

50MG/25ML (2MG/ML)

Approval Date

2007-08-09

Regulatory Status

RX

2007
09 Aug
RX Application: 65331

Drug Name

EPIRUBICIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2007-08-09

65331 / 2

Active Ingredient

EPIRUBICIN HYDROCHLORIDE

Application Number

65331

Product Number

2

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2007-08-09

Regulatory Status

RX

2008
26 Mar
RX Application: 76509

Drug Name

FENOFIBRATE

Product Number

1

Dosage Form

-

Strength

54MG

Approval Date

2008-03-26

76509 / 1

Active Ingredient

FENOFIBRATE

Application Number

76509

Product Number

1

Dosage Form

-

Strength

54MG

Approval Date

2008-03-26

Regulatory Status

RX

2008
26 Mar
RX Application: 76509

Drug Name

FENOFIBRATE

Product Number

2

Dosage Form

-

Strength

160MG

Approval Date

2008-03-26

76509 / 2

Active Ingredient

FENOFIBRATE

Application Number

76509

Product Number

2

Dosage Form

-

Strength

160MG

Approval Date

2008-03-26

Regulatory Status

RX

2003
27 Oct
Discontinued Application: 75868

Drug Name

FENOFIBRATE (MICRONIZED)

Product Number

1

Dosage Form

-

Strength

67MG

Approval Date

2003-10-27

75868 / 1

Active Ingredient

FENOFIBRATE

Application Number

75868

Product Number

1

Dosage Form

-

Strength

67MG

Approval Date

2003-10-27

Regulatory Status

Discontinued

2003
27 Oct
Discontinued Application: 75868

Drug Name

FENOFIBRATE (MICRONIZED)

Product Number

2

Dosage Form

-

Strength

134MG

Approval Date

2003-10-27

75868 / 2

Active Ingredient

FENOFIBRATE

Application Number

75868

Product Number

2

Dosage Form

-

Strength

134MG

Approval Date

2003-10-27

Regulatory Status

Discontinued

2003
27 Oct
Discontinued Application: 75868

Drug Name

FENOFIBRATE (MICRONIZED)

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2003-10-27

75868 / 3

Active Ingredient

FENOFIBRATE

Application Number

75868

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2003-10-27

Regulatory Status

Discontinued

2016
07 Sep
RX Application: 200264

Drug Name

FENOFIBRIC ACID

Product Number

1

Dosage Form

-

Strength

EQ 45MG FENOFIBRIC ACID

Approval Date

2016-09-07

200264 / 1

Active Ingredient

CHOLINE FENOFIBRATE

Application Number

200264

Product Number

1

Dosage Form

-

Strength

EQ 45MG FENOFIBRIC ACID

Approval Date

2016-09-07

Regulatory Status

RX

2016
07 Sep
RX Application: 200264

Drug Name

FENOFIBRIC ACID

Product Number

2

Dosage Form

-

Strength

EQ 135MG FENOFIBRIC ACID

Approval Date

2016-09-07

200264 / 2

Active Ingredient

CHOLINE FENOFIBRATE

Application Number

200264

Product Number

2

Dosage Form

-

Strength

EQ 135MG FENOFIBRIC ACID

Approval Date

2016-09-07

Regulatory Status

RX

2010
12 Nov
Discontinued Application: 76298

Drug Name

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG;120MG

Approval Date

2010-11-12

76298 / 1

Active Ingredient

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

76298

Product Number

1

Dosage Form

-

Strength

60MG;120MG

Approval Date

2010-11-12

Regulatory Status

Discontinued

2003
28 Aug
Discontinued Application: 76234

Drug Name

FLAVOXATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2003-08-28

76234 / 1

Active Ingredient

FLAVOXATE HYDROCHLORIDE

Application Number

76234

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2003-08-28

Regulatory Status

Discontinued

2002
18 Mar
RX Application: 40431

Drug Name

FLUDROCORTISONE ACETATE

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2002-03-18

40431 / 1

Active Ingredient

FLUDROCORTISONE ACETATE

Application Number

40431

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2002-03-18

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 80686

Drug Name

FOLIC ACID

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

80686 / 1

Active Ingredient

FOLIC ACID

Application Number

80686

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2009
27 May
Discontinued Application: 78484

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2009-05-27

78484 / 1

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

78484

Product Number

1

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2009-05-27

Regulatory Status

Discontinued

2009
27 May
Discontinued Application: 78484

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

EQ 16MG BASE

Approval Date

2009-05-27

78484 / 2

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

78484

Product Number

2

Dosage Form

-

Strength

EQ 16MG BASE

Approval Date

2009-05-27

Regulatory Status

Discontinued

2009
27 May
Discontinued Application: 78484

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

3

Dosage Form

-

Strength

EQ 24MG BASE

Approval Date

2009-05-27

78484 / 3

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

78484

Product Number

3

Dosage Form

-

Strength

EQ 24MG BASE

Approval Date

2009-05-27

Regulatory Status

Discontinued

2007
01 Jun
RX Application: 78207

Drug Name

GEMFIBROZIL

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2007-06-01

78207 / 1

Active Ingredient

GEMFIBROZIL

Application Number

78207

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2007-06-01

Regulatory Status

RX

2015
30 Sep
RX Application: 206079

Drug Name

GLYBURIDE

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

2015-09-30

206079 / 1

Active Ingredient

GLYBURIDE

Application Number

206079

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

2015-09-30

Regulatory Status

RX

2015
30 Sep
RX Application: 206079

Drug Name

GLYBURIDE

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2015-09-30

206079 / 2

Active Ingredient

GLYBURIDE

Application Number

206079

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2015-09-30

Regulatory Status

RX

2015
30 Sep
RX Application: 206079

Drug Name

GLYBURIDE

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2015-09-30

206079 / 3

Active Ingredient

GLYBURIDE

Application Number

206079

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2015-09-30

Regulatory Status

RX

2004
19 Nov
Discontinued Application: 76731

Drug Name

GLYBURIDE AND METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1.25MG;250MG

Approval Date

2004-11-19

76731 / 1

Active Ingredient

GLYBURIDE; METFORMIN HYDROCHLORIDE

Application Number

76731

Product Number

1

Dosage Form

-

Strength

1.25MG;250MG

Approval Date

2004-11-19

Regulatory Status

Discontinued

2004
19 Nov
Discontinued Application: 76731

Drug Name

GLYBURIDE AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2.5MG;500MG

Approval Date

2004-11-19

76731 / 2

Active Ingredient

GLYBURIDE; METFORMIN HYDROCHLORIDE

Application Number

76731

Product Number

2

Dosage Form

-

Strength

2.5MG;500MG

Approval Date

2004-11-19

Regulatory Status

Discontinued

2004
19 Nov
Discontinued Application: 76731

Drug Name

GLYBURIDE AND METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

5MG;500MG

Approval Date

2004-11-19

76731 / 3

Active Ingredient

GLYBURIDE; METFORMIN HYDROCHLORIDE

Application Number

76731

Product Number

3

Dosage Form

-

Strength

5MG;500MG

Approval Date

2004-11-19

Regulatory Status

Discontinued

2015
20 Oct
Discontinued Application: 202238

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2015-10-20

202238 / 1

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

202238

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2015-10-20

Regulatory Status

Discontinued

2015
20 Oct
Discontinued Application: 202238

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2015-10-20

202238 / 2

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

202238

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2015-10-20

Regulatory Status

Discontinued

2015
20 Oct
Discontinued Application: 202238

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2015-10-20

202238 / 3

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

202238

Product Number

3

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2015-10-20

Regulatory Status

Discontinued

2015
20 Oct
Discontinued Application: 202238

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2015-10-20

202238 / 4

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

202238

Product Number

4

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2015-10-20

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84922

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

84922 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

84922

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84923

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

84923 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

84923

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83607

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

83607 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

83607

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84029

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

84029 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

84029

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85098

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

85098 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

85098

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2007
30 Mar
RX Application: 40646

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-03-30

40646 / 1

Active Ingredient

HYDROCORTISONE

Application Number

40646

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-03-30

Regulatory Status

RX

2007
30 Mar
RX Application: 40646

Drug Name

HYDROCORTISONE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-03-30

40646 / 2

Active Ingredient

HYDROCORTISONE

Application Number

40646

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-03-30

Regulatory Status

RX

2007
30 Mar
RX Application: 40646

Drug Name

HYDROCORTISONE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2007-03-30

40646 / 3

Active Ingredient

HYDROCORTISONE

Application Number

40646

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2007-03-30

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 80781

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

80781 / 1

Active Ingredient

HYDROCORTISONE

Application Number

80781

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996
15 Jul
RX Application: 40156

Drug Name

HYDROXYZINE PAMOATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG HYDROCHLORIDE

Approval Date

1996-07-15

40156 / 1

Active Ingredient

HYDROXYZINE PAMOATE

Application Number

40156

Product Number

1

Dosage Form

-

Strength

EQ 25MG HYDROCHLORIDE

Approval Date

1996-07-15

Regulatory Status

RX

1996
15 Jul
RX Application: 40156

Drug Name

HYDROXYZINE PAMOATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG HYDROCHLORIDE

Approval Date

1996-07-15

40156 / 2

Active Ingredient

HYDROXYZINE PAMOATE

Application Number

40156

Product Number

2

Dosage Form

-

Strength

EQ 50MG HYDROCHLORIDE

Approval Date

1996-07-15

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 80153

Drug Name

ISONIAZID

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

80153 / 1

Active Ingredient

ISONIAZID

Application Number

80153

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2008
17 Mar
Discontinued Application: 40723

Drug Name

ISOSORBIDE DINITRATE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2008-03-17

40723 / 1

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

40723

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2008-03-17

Regulatory Status

Discontinued

2013
15 Jul
RX Application: 200828

Drug Name

LAMOTRIGINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2013-07-15

200828 / 1

Active Ingredient

LAMOTRIGINE

Application Number

200828

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2013-07-15

Regulatory Status

RX

2013
15 Jul
RX Application: 200828

Drug Name

LAMOTRIGINE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2013-07-15

200828 / 2

Active Ingredient

LAMOTRIGINE

Application Number

200828

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2013-07-15

Regulatory Status

RX

2013
15 Jul
RX Application: 200828

Drug Name

LAMOTRIGINE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2013-07-15

200828 / 3

Active Ingredient

LAMOTRIGINE

Application Number

200828

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2013-07-15

Regulatory Status

RX

2013
15 Jul
RX Application: 200828

Drug Name

LAMOTRIGINE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2013-07-15

200828 / 4

Active Ingredient

LAMOTRIGINE

Application Number

200828

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2013-07-15

Regulatory Status

RX

2011
03 Jun
Discontinued Application: 91638

Drug Name

LETROZOLE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2011-06-03

91638 / 1

Active Ingredient

LETROZOLE

Application Number

91638

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2011-06-03

Regulatory Status

Discontinued

2008
09 Apr
RX Application: 77756

Drug Name

LEVALBUTEROL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.021% BASE

Approval Date

2008-04-09

77756 / 1

Active Ingredient

LEVALBUTEROL HYDROCHLORIDE

Application Number

77756

Product Number

1

Dosage Form

-

Strength

EQ 0.021% BASE

Approval Date

2008-04-09

Regulatory Status

RX

2008
09 Apr
RX Application: 77756

Drug Name

LEVALBUTEROL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 0.042% BASE

Approval Date

2008-04-09

77756 / 2

Active Ingredient

LEVALBUTEROL HYDROCHLORIDE

Application Number

77756

Product Number

2

Dosage Form

-

Strength

EQ 0.042% BASE

Approval Date

2008-04-09

Regulatory Status

RX

2008
09 Apr
RX Application: 77756

Drug Name

LEVALBUTEROL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 0.0103% BASE

Approval Date

2008-04-09

77756 / 3

Active Ingredient

LEVALBUTEROL HYDROCHLORIDE

Application Number

77756

Product Number

3

Dosage Form

-

Strength

EQ 0.0103% BASE

Approval Date

2008-04-09

Regulatory Status

RX

2006
19 Jul
Discontinued Application: 77930

Drug Name

MELOXICAM

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2006-07-19

77930 / 1

Active Ingredient

MELOXICAM

Application Number

77930

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2006-07-19

Regulatory Status

Discontinued

2006
19 Jul
Discontinued Application: 77930

Drug Name

MELOXICAM

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2006-07-19

77930 / 2

Active Ingredient

MELOXICAM

Application Number

77930

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2006-07-19

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 14322

Drug Name

MEPROBAMATE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1982-01-01

14322 / 1

Active Ingredient

MEPROBAMATE

Application Number

14322

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 14322

Drug Name

MEPROBAMATE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

14322 / 2

Active Ingredient

MEPROBAMATE

Application Number

14322

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2004
30 Jul
Discontinued Application: 76249

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2004-07-30

76249 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

76249

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2004-07-30

Regulatory Status

Discontinued

2005
13 Sep
Discontinued Application: 76985

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2005-09-13

76985 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

76985

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2005-09-13

Regulatory Status

Discontinued

2003
20 Jun
Discontinued Application: 76411

Drug Name

METHENAMINE HIPPURATE

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2003-06-20

76411 / 1

Active Ingredient

METHENAMINE HIPPURATE

Application Number

76411

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2003-06-20

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84927

Drug Name

METHOCARBAMOL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

84927 / 1

Active Ingredient

METHOCARBAMOL

Application Number

84927

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84928

Drug Name

METHOCARBAMOL

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

1982-01-01

84928 / 1

Active Ingredient

METHOCARBAMOL

Application Number

84928

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2016
28 Jul
RX Application: 205105

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2016-07-28

205105 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

205105

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2016-07-28

Regulatory Status

RX

2016
28 Jul
RX Application: 205105

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2016-07-28

205105 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

205105

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2016-07-28

Regulatory Status

RX

2016
28 Jul
RX Application: 205105

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2016-07-28

205105 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

205105

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2016-07-28

Regulatory Status

RX

2016
28 Jul
RX Application: 205105

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2016-07-28

205105 / 4

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

205105

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2016-07-28

Regulatory Status

RX

2016
28 Jul
RX Application: 205105

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2016-07-28

205105 / 5

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

205105

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2016-07-28

Regulatory Status

RX

2016
28 Jul
RX Application: 205105

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2016-07-28

205105 / 6

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

205105

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2016-07-28

Regulatory Status

RX

1982
01 Jan
RX Application: 80767

Drug Name

METHYLTESTOSTERONE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

80767 / 2

Active Ingredient

METHYLTESTOSTERONE

Application Number

80767

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 84287

Drug Name

METHYLTESTOSTERONE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

84287 / 1

Active Ingredient

METHYLTESTOSTERONE

Application Number

84287

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84310

Drug Name

METHYLTESTOSTERONE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

84310 / 1

Active Ingredient

METHYLTESTOSTERONE

Application Number

84310

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2015
21 Sep
RX Application: 204851

Drug Name

METHYLTESTOSTERONE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2015-09-21

204851 / 1

Active Ingredient

METHYLTESTOSTERONE

Application Number

204851

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2015-09-21

Regulatory Status

RX

1988
03 Feb
Discontinued Application: 71250

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1988-02-03

71250 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

71250

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1988-02-03

Regulatory Status

Discontinued

1995
28 Dec
Discontinued Application: 71250

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1995-12-28

71250 / 2

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

71250

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1995-12-28

Regulatory Status

Discontinued

2004
27 May
Discontinued Application: 76449

Drug Name

MIDODRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2004-05-27

76449 / 1

Active Ingredient

MIDODRINE HYDROCHLORIDE

Application Number

76449

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2004-05-27

Regulatory Status

Discontinued

2004
27 May
Discontinued Application: 76449

Drug Name

MIDODRINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2004-05-27

76449 / 2

Active Ingredient

MIDODRINE HYDROCHLORIDE

Application Number

76449

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2004-05-27

Regulatory Status

Discontinued

2005
16 Dec
Discontinued Application: 76449

Drug Name

MIDODRINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2005-12-16

76449 / 3

Active Ingredient

MIDODRINE HYDROCHLORIDE

Application Number

76449

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2005-12-16

Regulatory Status

Discontinued

1999
23 Mar
RX Application: 65005

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1999-03-23

65005 / 1

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

65005

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1999-03-23

Regulatory Status

RX

1999
23 Mar
RX Application: 65005

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1999-03-23

65005 / 2

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

65005

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1999-03-23

Regulatory Status

RX

2001
18 Apr
RX Application: 65005

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2001-04-18

65005 / 3

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

65005

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2001-04-18

Regulatory Status

RX

2009
03 Feb
Discontinued Application: 90024

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2009-02-03

90024 / 1

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

90024

Product Number

1

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2009-02-03

Regulatory Status

Discontinued

2009
03 Feb
Discontinued Application: 90024

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 90MG BASE

Approval Date

2009-02-03

90024 / 2

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

90024

Product Number

2

Dosage Form

-

Strength

EQ 90MG BASE

Approval Date

2009-02-03

Regulatory Status

Discontinued

2009
03 Feb
Discontinued Application: 90024

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 135MG BASE

Approval Date

2009-02-03

90024 / 3

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

90024

Product Number

3

Dosage Form

-

Strength

EQ 135MG BASE

Approval Date

2009-02-03

Regulatory Status

Discontinued

2005
28 Jun
Discontinued Application: 76901

Drug Name

MIRTAZAPINE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2005-06-28

76901 / 1

Active Ingredient

MIRTAZAPINE

Application Number

76901

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2005-06-28

Regulatory Status

Discontinued

2005
28 Jun
Discontinued Application: 76901

Drug Name

MIRTAZAPINE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2005-06-28

76901 / 2

Active Ingredient

MIRTAZAPINE

Application Number

76901

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2005-06-28

Regulatory Status

Discontinued

2005
28 Jun
Discontinued Application: 76901

Drug Name

MIRTAZAPINE

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2005-06-28

76901 / 3

Active Ingredient

MIRTAZAPINE

Application Number

76901

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2005-06-28

Regulatory Status

Discontinued

2016
12 Apr
Discontinued Application: 200411

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2016-04-12

200411 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

200411

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2016-04-12

Regulatory Status

Discontinued

2016
12 Apr
Discontinued Application: 200411

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2016-04-12

200411 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

200411

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2016-04-12

Regulatory Status

Discontinued

2016
12 Apr
Discontinued Application: 200411

Drug Name

MORPHINE SULFATE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2016-04-12

200411 / 3

Active Ingredient

MORPHINE SULFATE

Application Number

200411

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2016-04-12

Regulatory Status

Discontinued

2016
12 Apr
Discontinued Application: 200411

Drug Name

MORPHINE SULFATE

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

2016-04-12

200411 / 4

Active Ingredient

MORPHINE SULFATE

Application Number

200411

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

2016-04-12

Regulatory Status

Discontinued

2016
12 Apr
Discontinued Application: 200411

Drug Name

MORPHINE SULFATE

Product Number

5

Dosage Form

-

Strength

80MG

Approval Date

2016-04-12

200411 / 5

Active Ingredient

MORPHINE SULFATE

Application Number

200411

Product Number

5

Dosage Form

-

Strength

80MG

Approval Date

2016-04-12

Regulatory Status

Discontinued

2016
12 Apr
Discontinued Application: 200411

Drug Name

MORPHINE SULFATE

Product Number

6

Dosage Form

-

Strength

100MG

Approval Date

2016-04-12

200411 / 6

Active Ingredient

MORPHINE SULFATE

Application Number

200411

Product Number

6

Dosage Form

-

Strength

100MG

Approval Date

2016-04-12

Regulatory Status

Discontinued

2018
25 Jul
Discontinued Application: 200411

Drug Name

MORPHINE SULFATE

Product Number

7

Dosage Form

-

Strength

40MG

Approval Date

2018-07-25

200411 / 7

Active Ingredient

MORPHINE SULFATE

Application Number

200411

Product Number

7

Dosage Form

-

Strength

40MG

Approval Date

2018-07-25

Regulatory Status

Discontinued

2000
26 May
Discontinued Application: 75189

Drug Name

NABUMETONE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2000-05-26

75189 / 1

Active Ingredient

NABUMETONE

Application Number

75189

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2000-05-26

Regulatory Status

Discontinued

2001
24 Sep
Discontinued Application: 75189

Drug Name

NABUMETONE

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2001-09-24

75189 / 2

Active Ingredient

NABUMETONE

Application Number

75189

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2001-09-24

Regulatory Status

Discontinued

2007
30 Mar
Discontinued Application: 77833

Drug Name

NADOLOL AND BENDROFLUMETHIAZIDE

Product Number

1

Dosage Form

-

Strength

5MG;40MG

Approval Date

2007-03-30

77833 / 1

Active Ingredient

BENDROFLUMETHIAZIDE; NADOLOL

Application Number

77833

Product Number

1

Dosage Form

-

Strength

5MG;40MG

Approval Date

2007-03-30

Regulatory Status

Discontinued

2007
30 Mar
Discontinued Application: 77833

Drug Name

NADOLOL AND BENDROFLUMETHIAZIDE

Product Number

2

Dosage Form

-

Strength

5MG;80MG

Approval Date

2007-03-30

77833 / 2

Active Ingredient

BENDROFLUMETHIAZIDE; NADOLOL

Application Number

77833

Product Number

2

Dosage Form

-

Strength

5MG;80MG

Approval Date

2007-03-30

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83115

Drug Name

NIACIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

83115 / 1

Active Ingredient

NIACIN

Application Number

83115

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1993
28 Jan
RX Application: 73652

Drug Name

NITROFURANTOIN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1993-01-28

73652 / 1

Active Ingredient

NITROFURANTOIN, MACROCRYSTALLINE

Application Number

73652

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1993-01-28

Regulatory Status

RX

1993
28 Jan
RX Application: 73671

Drug Name

NITROFURANTOIN

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1993-01-28

73671 / 1

Active Ingredient

NITROFURANTOIN, MACROCRYSTALLINE

Application Number

73671

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1993-01-28

Regulatory Status

RX

2007
22 Oct
RX Application: 75785

Drug Name

OMEPRAZOLE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2007-10-22

75785 / 1

Active Ingredient

OMEPRAZOLE

Application Number

75785

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2007-10-22

Regulatory Status

RX

2007
22 Oct
RX Application: 75785

Drug Name

OMEPRAZOLE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2007-10-22

75785 / 2

Active Ingredient

OMEPRAZOLE

Application Number

75785

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2007-10-22

Regulatory Status

RX

2009
21 Jan
RX Application: 75785

Drug Name

OMEPRAZOLE

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2009-01-21

75785 / 3

Active Ingredient

OMEPRAZOLE

Application Number

75785

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2009-01-21

Regulatory Status

RX

2006
09 Nov
Discontinued Application: 76745

Drug Name

OXYBUTYNIN CHLORIDE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2006-11-09

76745 / 1

Active Ingredient

OXYBUTYNIN CHLORIDE

Application Number

76745

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2006-11-09

Regulatory Status

Discontinued

2007
09 May
Discontinued Application: 76745

Drug Name

OXYBUTYNIN CHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2007-05-09

76745 / 2

Active Ingredient

OXYBUTYNIN CHLORIDE

Application Number

76745

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2007-05-09

Regulatory Status

Discontinued

2007
09 May
Discontinued Application: 76745

Drug Name

OXYBUTYNIN CHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2007-05-09

76745 / 3

Active Ingredient

OXYBUTYNIN CHLORIDE

Application Number

76745

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2007-05-09

Regulatory Status

Discontinued

-
Unclassified Application: 76318

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

-

76318 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

76318

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 76446

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

-

76446 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

76446

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 76446

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

-

76446 / 2

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

76446

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 76446

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

-

76446 / 3

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

76446

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

-

Regulatory Status

Unclassified

2010
14 Jun
RX Application: 79087

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2010-06-14

79087 / 1

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

79087

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2010-06-14

Regulatory Status

RX

2010
21 Dec
RX Application: 79087

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2010-12-21

79087 / 2

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

79087

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2010-12-21

Regulatory Status

RX

2010
14 Jun
RX Application: 79087

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2010-06-14

79087 / 3

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

79087

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2010-06-14

Regulatory Status

RX

2010
21 Dec
RX Application: 79087

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2010-12-21

79087 / 4

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

79087

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2010-12-21

Regulatory Status

RX

2010
14 Jun
RX Application: 79087

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2010-06-14

79087 / 5

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

79087

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2010-06-14

Regulatory Status

RX

2010
22 Jul
RX Application: 79087

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2010-07-22

79087 / 6

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

79087

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2010-07-22

Regulatory Status

RX

2010
14 Jun
RX Application: 79087

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

7

Dosage Form

-

Strength

40MG

Approval Date

2010-06-14

79087 / 7

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

79087

Product Number

7

Dosage Form

-

Strength

40MG

Approval Date

2010-06-14

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 60760

Drug Name

OXYTETRACYCLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

60760 / 1

Active Ingredient

OXYTETRACYCLINE HYDROCHLORIDE

Application Number

60760

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1999
10 Aug
Discontinued Application: 75093

Drug Name

PENTOXIFYLLINE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1999-08-10

75093 / 1

Active Ingredient

PENTOXIFYLLINE

Application Number

75093

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1999-08-10

Regulatory Status

Discontinued

2006
31 Mar
RX Application: 77248

Drug Name

PILOCARPINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-03-31

77248 / 1

Active Ingredient

PILOCARPINE HYDROCHLORIDE

Application Number

77248

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-03-31

Regulatory Status

RX

2006
31 Mar
RX Application: 77248

Drug Name

PILOCARPINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2006-03-31

77248 / 2

Active Ingredient

PILOCARPINE HYDROCHLORIDE

Application Number

77248

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2006-03-31

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 80874

Drug Name

PIPERAZINE CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

80874 / 1

Active Ingredient

PIPERAZINE CITRATE

Application Number

80874

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80780

Drug Name

PREDNISOLONE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

80780 / 1

Active Ingredient

PREDNISOLONE

Application Number

80780

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80782

Drug Name

PREDNISONE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

80782 / 1

Active Ingredient

PREDNISONE

Application Number

80782

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2008
12 Feb
Discontinued Application: 40717

Drug Name

PRIMIDONE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2008-02-12

40717 / 1

Active Ingredient

PRIMIDONE

Application Number

40717

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2008-02-12

Regulatory Status

Discontinued

2008
12 Feb
Discontinued Application: 40717

Drug Name

PRIMIDONE

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2008-02-12

40717 / 2

Active Ingredient

PRIMIDONE

Application Number

40717

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2008-02-12

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83720

Drug Name

PROBENECID AND COLCHICINE

Product Number

2

Dosage Form

-

Strength

0.5MG;500MG

Approval Date

1982-01-01

83720 / 2

Active Ingredient

COLCHICINE; PROBENECID

Application Number

83720

Product Number

2

Dosage Form

-

Strength

0.5MG;500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2008
20 May
Discontinued Application: 40791

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2008-05-20

40791 / 1

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40791

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2008-05-20

Regulatory Status

Discontinued

2008
12 Feb
Discontinued Application: 40791

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

12.5MG

Approval Date

2008-02-12

40791 / 2

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40791

Product Number

2

Dosage Form

-

Strength

12.5MG

Approval Date

2008-02-12

Regulatory Status

Discontinued

2008
12 Feb
Discontinued Application: 40791

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2008-02-12

40791 / 3

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40791

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2008-02-12

Regulatory Status

Discontinued

1982
07 Jul
Discontinued Application: 84214

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1982-07-07

84214 / 2

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

84214

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1982-07-07

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84541

Drug Name

PROPANTHELINE BROMIDE

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

84541 / 2

Active Ingredient

PROPANTHELINE BROMIDE

Application Number

84541

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83317

Drug Name

PROPOXYPHENE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

65MG

Approval Date

1982-01-01

83317 / 1

Active Ingredient

PROPOXYPHENE HYDROCHLORIDE

Application Number

83317

Product Number

1

Dosage Form

-

Strength

65MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1988
06 Apr
RX Application: 71972

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1988-04-06

71972 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

71972

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1988-04-06

Regulatory Status

RX

1988
06 Apr
RX Application: 71972

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1988-04-06

71972 / 2

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

71972

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1988-04-06

Regulatory Status

RX

1988
06 Apr
RX Application: 71972

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

1988-04-06

71972 / 3

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

71972

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

1988-04-06

Regulatory Status

RX

1988
06 Apr
RX Application: 71976

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1988-04-06

71976 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

71976

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1988-04-06

Regulatory Status

RX

1986
13 May
RX Application: 71976

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

1986-05-13

71976 / 2

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

71976

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

1986-05-13

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 80159

Drug Name

PROPYLTHIOURACIL

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

80159 / 1

Active Ingredient

PROPYLTHIOURACIL

Application Number

80159

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2002
26 Dec
Discontinued Application: 40457

Drug Name

PYRIDOSTIGMINE BROMIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2002-12-26

40457 / 1

Active Ingredient

PYRIDOSTIGMINE BROMIDE

Application Number

40457

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2002-12-26

Regulatory Status

Discontinued

2003
24 Apr
RX Application: 40502

Drug Name

PYRIDOSTIGMINE BROMIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2003-04-24

40502 / 1

Active Ingredient

PYRIDOSTIGMINE BROMIDE

Application Number

40502

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2003-04-24

Regulatory Status

RX

2022
28 Jun
RX Application: 40502

Drug Name

PYRIDOSTIGMINE BROMIDE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2022-06-28

40502 / 2

Active Ingredient

PYRIDOSTIGMINE BROMIDE

Application Number

40502

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2022-06-28

Regulatory Status

RX

2015
15 Sep
Discontinued Application: 203184

Drug Name

PYRIDOSTIGMINE BROMIDE

Product Number

1

Dosage Form

-

Strength

180MG

Approval Date

2015-09-15

203184 / 1

Active Ingredient

PYRIDOSTIGMINE BROMIDE

Application Number

203184

Product Number

1

Dosage Form

-

Strength

180MG

Approval Date

2015-09-15

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80808

Drug Name

PYRILAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

80808 / 1

Active Ingredient

PYRILAMINE MALEATE

Application Number

80808

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83347

Drug Name

QUINIDINE SULFATE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

83347 / 1

Active Ingredient

QUINIDINE SULFATE

Application Number

83347

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9273

Drug Name

RAUWOLFIA SERPENTINA

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Active Ingredient

RAUWOLFIA SERPENTINA ROOT

Application Number

9273

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9273

Drug Name

RAUWOLFIA SERPENTINA

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Active Ingredient

RAUWOLFIA SERPENTINA ROOT

Application Number

9273

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9627

Drug Name

RESERPINE

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

Active Ingredient

RESERPINE

Application Number

9627

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9627

Drug Name

RESERPINE

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

Active Ingredient

RESERPINE

Application Number

9627

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2003
29 Jan
RX Application: 76173

Drug Name

RILUZOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-01-29

76173 / 1

Active Ingredient

RILUZOLE

Application Number

76173

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-01-29

Regulatory Status

RX

2001
02 Nov
Discontinued Application: 75916

Drug Name

RIMANTADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2001-11-02

75916 / 1

Active Ingredient

RIMANTADINE HYDROCHLORIDE

Application Number

75916

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2001-11-02

Regulatory Status

Discontinued

2002
30 Aug
RX Application: 76132

Drug Name

RIMANTADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2002-08-30

76132 / 1

Active Ingredient

RIMANTADINE HYDROCHLORIDE

Application Number

76132

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2002-08-30

Regulatory Status

RX

2018
29 Jun
Discontinued Application: 205066

Drug Name

RISEDRONATE SODIUM

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

2018-06-29

205066 / 1

Active Ingredient

RISEDRONATE SODIUM

Application Number

205066

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

2018-06-29

Regulatory Status

Discontinued

2017
23 Oct
Discontinued Application: 90975

Drug Name

SEVELAMER CARBONATE

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

2017-10-23

90975 / 1

Active Ingredient

SEVELAMER CARBONATE

Application Number

90975

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

2017-10-23

Regulatory Status

Discontinued

2000
07 Nov
Discontinued Application: 75663

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2000-11-07

75663 / 1

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

75663

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2000-11-07

Regulatory Status

Discontinued

2000
07 Nov
Discontinued Application: 75663

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2000-11-07

75663 / 2

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

75663

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2000-11-07

Regulatory Status

Discontinued

2000
07 Nov
Discontinued Application: 75663

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2000-11-07

75663 / 3

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

75663

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2000-11-07

Regulatory Status

Discontinued

2000
07 Nov
Discontinued Application: 75663

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

240MG

Approval Date

2000-11-07

75663 / 4

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

75663

Product Number

4

Dosage Form

-

Strength

240MG

Approval Date

2000-11-07

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80079

Drug Name

SULFA-TRIPLE #2

Product Number

1

Dosage Form

-

Strength

167MG;167MG;167MG

Approval Date

1982-01-01

80079 / 1

Active Ingredient

TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)

Application Number

80079

Product Number

1

Dosage Form

-

Strength

167MG;167MG;167MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80081

Drug Name

SULFADIAZINE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

80081 / 1

Active Ingredient

SULFADIAZINE

Application Number

80081

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80109

Drug Name

SULFISOXAZOLE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

80109 / 1

Active Ingredient

SULFISOXAZOLE

Application Number

80109

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2010
02 Mar
RX Application: 90377

Drug Name

TAMSULOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.4MG

Approval Date

2010-03-02

90377 / 1

Active Ingredient

TAMSULOSIN HYDROCHLORIDE

Application Number

90377

Product Number

1

Dosage Form

-

Strength

0.4MG

Approval Date

2010-03-02

Regulatory Status

RX

2001
26 Jun
RX Application: 75877

Drug Name

TERBUTALINE SULFATE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2001-06-26

75877 / 1

Active Ingredient

TERBUTALINE SULFATE

Application Number

75877

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2001-06-26

Regulatory Status

RX

2001
26 Jun
RX Application: 75877

Drug Name

TERBUTALINE SULFATE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2001-06-26

75877 / 2

Active Ingredient

TERBUTALINE SULFATE

Application Number

75877

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2001-06-26

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 60469

Drug Name

TETRACYCLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

60469 / 1

Active Ingredient

TETRACYCLINE HYDROCHLORIDE

Application Number

60469

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60469

Drug Name

TETRACYCLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

60469 / 2

Active Ingredient

TETRACYCLINE HYDROCHLORIDE

Application Number

60469

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60469

Drug Name

TETRACYCLINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

60469 / 3

Active Ingredient

TETRACYCLINE HYDROCHLORIDE

Application Number

60469

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84340

Drug Name

TRIAMCINOLONE

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

84340 / 1

Active Ingredient

TRIAMCINOLONE

Application Number

84340

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83967

Drug Name

TRICHLORMETHIAZIDE

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

83967 / 1

Active Ingredient

TRICHLORMETHIAZIDE

Application Number

83967

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80785

Drug Name

TRIPELENNAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

80785 / 1

Active Ingredient

TRIPELENNAMINE HYDROCHLORIDE

Application Number

80785

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2006
27 Jul
Discontinued Application: 77895

Drug Name

URSODIOL

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2006-07-27

77895 / 1

Active Ingredient

URSODIOL

Application Number

77895

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2006-07-27

Regulatory Status

Discontinued

2011
23 Dec
Discontinued Application: 200826

Drug Name

URSODIOL

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2011-12-23

200826 / 1

Active Ingredient

URSODIOL

Application Number

200826

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2011-12-23

Regulatory Status

Discontinued

2011
23 Dec
Discontinued Application: 200826

Drug Name

URSODIOL

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2011-12-23

200826 / 2

Active Ingredient

URSODIOL

Application Number

200826

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2011-12-23

Regulatory Status

Discontinued

-
Unclassified Application: 78057

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

-

78057 / 1

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

78057

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 78057

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

75MG

Approval Date

-

78057 / 2

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

78057

Product Number

2

Dosage Form

-

Strength

75MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 78057

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

-

78057 / 3

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

78057

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

-

Regulatory Status

Unclassified

1982
01 Jan
Discontinued Application: 80952

Drug Name

VITAMIN A

Product Number

1

Dosage Form

-

Strength

50,000USP UNITS

Approval Date

1982-01-01

80952 / 1

Active Ingredient

VITAMIN A

Application Number

80952

Product Number

1

Dosage Form

-

Strength

50,000USP UNITS

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80953

Drug Name

VITAMIN A

Product Number

1

Dosage Form

-

Strength

EQ 50,000 UNITS BASE

Approval Date

1982-01-01

80953 / 1

Active Ingredient

VITAMIN A PALMITATE

Application Number

80953

Product Number

1

Dosage Form

-

Strength

EQ 50,000 UNITS BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80955

Drug Name

VITAMIN A

Product Number

1

Dosage Form

-

Strength

EQ 50,000 UNITS BASE

Approval Date

1982-01-01

80955 / 1

Active Ingredient

VITAMIN A PALMITATE

Application Number

80955

Product Number

1

Dosage Form

-

Strength

EQ 50,000 UNITS BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80951

Drug Name

VITAMIN D

Product Number

1

Dosage Form

-

Strength

50,000 IU

Approval Date

1982-01-01

80951 / 1

Active Ingredient

ERGOCALCIFEROL

Application Number

80951

Product Number

1

Dosage Form

-

Strength

50,000 IU

Approval Date

1982-01-01

Regulatory Status

Discontinued

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Drug Status Breakdown
283 total
  • RX
  • Discontinued
  • Unclassified
Official Source

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

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FDA Approved Drug Record Details Preview

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

Drug Name

ACARBOSE

Application Number

78441

Product Number

1

Active Ingredient

ACARBOSE

Dosage Form

-

Strength

25MG

FDA Approved Drug Data

Approved drug product information

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