ROXANE
FDA Approved Drugs

ROXANE

FDA Approved Drugs Database

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

Discontinued Unclassified
  • Total Records 169
  • Latest Approval Date Mar 24, 2011
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
169
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Unclassified
3
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Discontinued
166
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Company Overview

Company

ROXANE

Country

U.S.A

Website

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Company Snapshot

ROXANE

P.O. Box 16532, Columbus, OH 43216

U.S.A

www.roxane.com/ View on Map
FDA Approved Drug Records ( 169 records )
1982
01 Jan
Discontinued Application: 84656

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

1982-01-01

84656 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

84656

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84659

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

1982-01-01

84659 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

84659

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84667

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

1982-01-01

84667 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

84667

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1989
25 Apr
Discontinued Application: 89511

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

500MG;15MG

Approval Date

1989-04-25

89511 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

89511

Product Number

1

Dosage Form

-

Strength

500MG;15MG

Approval Date

1989-04-25

Regulatory Status

Discontinued

1989
25 Apr
Discontinued Application: 89512

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

500MG;30MG

Approval Date

1989-04-25

89512 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

89512

Product Number

1

Dosage Form

-

Strength

500MG;30MG

Approval Date

1989-04-25

Regulatory Status

Discontinued

1989
25 Apr
Discontinued Application: 89513

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

500MG;60MG

Approval Date

1989-04-25

89513 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

89513

Product Number

1

Dosage Form

-

Strength

500MG;60MG

Approval Date

1989-04-25

Regulatory Status

Discontinued

1992
30 Apr
Discontinued Application: 72323

Drug Name

ACETYLCYSTEINE

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1992-04-30

72323 / 1

Active Ingredient

ACETYLCYSTEINE

Application Number

72323

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1992-04-30

Regulatory Status

Discontinued

1992
30 Apr
Discontinued Application: 72324

Drug Name

ACETYLCYSTEINE

Product Number

1

Dosage Form

-

Strength

20%

Approval Date

1992-04-30

72324 / 1

Active Ingredient

ACETYLCYSTEINE

Application Number

72324

Product Number

1

Dosage Form

-

Strength

20%

Approval Date

1992-04-30

Regulatory Status

Discontinued

1992
30 Sep
Discontinued Application: 72621

Drug Name

ACETYLCYSTEINE

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1992-09-30

72621 / 1

Active Ingredient

ACETYLCYSTEINE

Application Number

72621

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1992-09-30

Regulatory Status

Discontinued

1992
30 Sep
Discontinued Application: 72622

Drug Name

ACETYLCYSTEINE

Product Number

1

Dosage Form

-

Strength

20%

Approval Date

1992-09-30

72622 / 1

Active Ingredient

ACETYLCYSTEINE

Application Number

72622

Product Number

1

Dosage Form

-

Strength

20%

Approval Date

1992-09-30

Regulatory Status

Discontinued

1997
22 Apr
Discontinued Application: 74570

Drug Name

ACYCLOVIR

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1997-04-22

74570 / 2

Active Ingredient

ACYCLOVIR

Application Number

74570

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1997-04-22

Regulatory Status

Discontinued

2001
13 Feb
Discontinued Application: 75129

Drug Name

ALBUTEROL SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 0.083% BASE

Approval Date

2001-02-13

75129 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

75129

Product Number

1

Dosage Form

-

Strength

EQ 0.083% BASE

Approval Date

2001-02-13

Regulatory Status

Discontinued

1993
19 Oct
Discontinued Application: 74199

Drug Name

ALPRAZOLAM

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

1993-10-19

74199 / 1

Active Ingredient

ALPRAZOLAM

Application Number

74199

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

1993-10-19

Regulatory Status

Discontinued

1993
19 Oct
Discontinued Application: 74199

Drug Name

ALPRAZOLAM

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1993-10-19

74199 / 2

Active Ingredient

ALPRAZOLAM

Application Number

74199

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1993-10-19

Regulatory Status

Discontinued

1993
19 Oct
Discontinued Application: 74199

Drug Name

ALPRAZOLAM

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

1993-10-19

74199 / 3

Active Ingredient

ALPRAZOLAM

Application Number

74199

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

1993-10-19

Regulatory Status

Discontinued

1993
31 Oct
Discontinued Application: 74314

Drug Name

ALPRAZOLAM

Product Number

1

Dosage Form

-

Strength

0.5MG/5ML

Approval Date

1993-10-31

74314 / 1

Active Ingredient

ALPRAZOLAM

Application Number

74314

Product Number

1

Dosage Form

-

Strength

0.5MG/5ML

Approval Date

1993-10-31

Regulatory Status

Discontinued

1982
09 Feb
Discontinued Application: 87500

Drug Name

AMINOPHYLLINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-02-09

87500 / 1

Active Ingredient

AMINOPHYLLINE

Application Number

87500

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-02-09

Regulatory Status

Discontinued

1982
09 Feb
Discontinued Application: 87501

Drug Name

AMINOPHYLLINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-02-09

87501 / 1

Active Ingredient

AMINOPHYLLINE

Application Number

87501

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-02-09

Regulatory Status

Discontinued

1983
19 Aug
Discontinued Application: 88126

Drug Name

AMINOPHYLLINE

Product Number

1

Dosage Form

-

Strength

105MG/5ML

Approval Date

1983-08-19

88126 / 1

Active Ingredient

AMINOPHYLLINE

Application Number

88126

Product Number

1

Dosage Form

-

Strength

105MG/5ML

Approval Date

1983-08-19

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85944

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

85944 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

85944

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85945

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

85945 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

85945

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86002

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

86002 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

86002

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86003

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

86003 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

86003

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86004

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

1982-01-01

86004 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

86004

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86090

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1982-01-01

86090 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

86090

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86143

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

86143 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

86143

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86144

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

86144 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

86144

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86145

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

86145 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

86145

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86146

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

86146 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

86146

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86147

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

1982-01-01

86147 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

86147

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86148

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1982-01-01

86148 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

86148

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2005
18 Apr
Discontinued Application: 76489

Drug Name

ANAGRELIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2005-04-18

76489 / 1

Active Ingredient

ANAGRELIDE HYDROCHLORIDE

Application Number

76489

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2005-04-18

Regulatory Status

Discontinued

2005
18 Apr
Discontinued Application: 76489

Drug Name

ANAGRELIDE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2005-04-18

76489 / 2

Active Ingredient

ANAGRELIDE HYDROCHLORIDE

Application Number

76489

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2005-04-18

Regulatory Status

Discontinued

2011
24 Mar
Discontinued Application: 78285

Drug Name

BICALUTAMIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2011-03-24

78285 / 1

Active Ingredient

BICALUTAMIDE

Application Number

78285

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2011-03-24

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84700

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

84700 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

84700

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84705

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

84705 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

84705

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84706

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

84706 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

84706

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80626

Drug Name

CHLORPHENIRAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

80626 / 1

Active Ingredient

CHLORPHENIRAMINE MALEATE

Application Number

80626

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2004
23 Nov
Discontinued Application: 77041

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2004-11-23

77041 / 1

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77041

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2004-11-23

Regulatory Status

Discontinued

2004
23 Nov
Discontinued Application: 77041

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2004-11-23

77041 / 2

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77041

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2004-11-23

Regulatory Status

Discontinued

2004
23 Nov
Discontinued Application: 77041

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2004-11-23

77041 / 3

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77041

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2004-11-23

Regulatory Status

Discontinued

1999
30 Sep
Discontinued Application: 75175

Drug Name

CROMOLYN SODIUM

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1999-09-30

75175 / 1

Active Ingredient

CROMOLYN SODIUM

Application Number

75175

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1999-09-30

Regulatory Status

Discontinued

1999
17 Aug
Discontinued Application: 40032

Drug Name

CYCLOPHOSPHAMIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1999-08-17

40032 / 1

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

40032

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1999-08-17

Regulatory Status

Discontinued

1999
17 Aug
Discontinued Application: 40032

Drug Name

CYCLOPHOSPHAMIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1999-08-17

40032 / 2

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

40032

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1999-08-17

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84614

Drug Name

DEXAMETHASONE

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

84614 / 1

Active Ingredient

DEXAMETHASONE

Application Number

84614

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1986
17 Jun
Discontinued Application: 70356

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1986-06-17

70356 / 1

Active Ingredient

DIAZEPAM

Application Number

70356

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1986-06-17

Regulatory Status

Discontinued

1986
17 Jun
Discontinued Application: 70357

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1986-06-17

70357 / 1

Active Ingredient

DIAZEPAM

Application Number

70357

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1986-06-17

Regulatory Status

Discontinued

1986
17 Jun
Discontinued Application: 70358

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1986-06-17

70358 / 1

Active Ingredient

DIAZEPAM

Application Number

70358

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1986-06-17

Regulatory Status

Discontinued

1995
29 Jun
Discontinued Application: 74391

Drug Name

DICLOFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1995-06-29

74391 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

74391

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1995-06-29

Regulatory Status

Discontinued

1995
29 Jun
Discontinued Application: 74391

Drug Name

DICLOFENAC SODIUM

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1995-06-29

74391 / 2

Active Ingredient

DICLOFENAC SODIUM

Application Number

74391

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1995-06-29

Regulatory Status

Discontinued

1995
29 Jun
Discontinued Application: 74391

Drug Name

DICLOFENAC SODIUM

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1995-06-29

74391 / 3

Active Ingredient

DICLOFENAC SODIUM

Application Number

74391

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1995-06-29

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80635

Drug Name

DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

80635 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

80635

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80643

Drug Name

DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

12.5MG/5ML

Approval Date

1982-01-01

80643 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

80643

Product Number

1

Dosage Form

-

Strength

12.5MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86057

Drug Name

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Product Number

1

Dosage Form

-

Strength

0.025MG;2.5MG

Approval Date

1982-01-01

86057 / 1

Active Ingredient

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

Application Number

86057

Product Number

1

Dosage Form

-

Strength

0.025MG;2.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76213

Drug Name

FLUCONAZOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-07-29

76213 / 1

Active Ingredient

FLUCONAZOLE

Application Number

76213

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76213

Drug Name

FLUCONAZOLE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2004-07-29

76213 / 2

Active Ingredient

FLUCONAZOLE

Application Number

76213

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76213

Drug Name

FLUCONAZOLE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2004-07-29

76213 / 3

Active Ingredient

FLUCONAZOLE

Application Number

76213

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76213

Drug Name

FLUCONAZOLE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2004-07-29

76213 / 4

Active Ingredient

FLUCONAZOLE

Application Number

76213

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84536

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

84536 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

84536

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85004

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

85004 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

85004

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85005

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

85005 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

85005

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
02 Jul
Discontinued Application: 88587

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-07-02

88587 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

88587

Product Number

1

Dosage Form

-

Strength

50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-07-02

Regulatory Status

Discontinued

1984
02 Jul
Discontinued Application: 88588

Drug Name

HYDROCHLOROTHIAZIDE INTENSOL

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1984-07-02

88588 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

88588

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1984-07-02

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84603

Drug Name

HYDROCHLOROTHIAZIDE W/ RESERPINE

Product Number

1

Dosage Form

-

Strength

50MG;0.125MG

Approval Date

1982-01-01

84603 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; RESERPINE

Application Number

84603

Product Number

1

Dosage Form

-

Strength

50MG;0.125MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
21 Mar
Discontinued Application: 88539

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1984-03-21

88539 / 1

Active Ingredient

HYDROCORTISONE

Application Number

88539

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1984-03-21

Regulatory Status

Discontinued

1995
18 Aug
Discontinued Application: 74476

Drug Name

HYDROXYUREA

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1995-08-18

74476 / 1

Active Ingredient

HYDROXYUREA

Application Number

74476

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1995-08-18

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83799

Drug Name

IMIPRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

83799 / 1

Active Ingredient

IMIPRAMINE HYDROCHLORIDE

Application Number

83799

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83799

Drug Name

IMIPRAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

83799 / 2

Active Ingredient

IMIPRAMINE HYDROCHLORIDE

Application Number

83799

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83799

Drug Name

IMIPRAMINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

83799 / 3

Active Ingredient

IMIPRAMINE HYDROCHLORIDE

Application Number

83799

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2002
22 Jul
Discontinued Application: 75867

Drug Name

IPRATROPIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

0.02%

Approval Date

2002-07-22

75867 / 1

Active Ingredient

IPRATROPIUM BROMIDE

Application Number

75867

Product Number

1

Dosage Form

-

Strength

0.02%

Approval Date

2002-07-22

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86899

Drug Name

ISOETHARINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

86899 / 1

Active Ingredient

ISOETHARINE HYDROCHLORIDE

Application Number

86899

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87025

Drug Name

ISOETHARINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.125%

Approval Date

1982-01-01

87025 / 1

Active Ingredient

ISOETHARINE HYDROCHLORIDE

Application Number

87025

Product Number

1

Dosage Form

-

Strength

0.125%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87324

Drug Name

ISOETHARINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

1982-01-01

87324 / 1

Active Ingredient

ISOETHARINE HYDROCHLORIDE

Application Number

87324

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87396

Drug Name

ISOETHARINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

87396 / 1

Active Ingredient

ISOETHARINE HYDROCHLORIDE

Application Number

87396

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1983
16 Sep
Discontinued Application: 88226

Drug Name

ISOETHARINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.167%

Approval Date

1983-09-16

88226 / 1

Active Ingredient

ISOETHARINE HYDROCHLORIDE

Application Number

88226

Product Number

1

Dosage Form

-

Strength

0.167%

Approval Date

1983-09-16

Regulatory Status

Discontinued

1983
03 Jun
Discontinued Application: 88275

Drug Name

ISOETHARINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1983-06-03

88275 / 1

Active Ingredient

ISOETHARINE HYDROCHLORIDE

Application Number

88275

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1983-06-03

Regulatory Status

Discontinued

1992
29 May
Discontinued Application: 73590

Drug Name

LACTULOSE

Product Number

1

Dosage Form

-

Strength

10GM/15ML

Approval Date

1992-05-29

73590 / 1

Active Ingredient

LACTULOSE

Application Number

73590

Product Number

1

Dosage Form

-

Strength

10GM/15ML

Approval Date

1992-05-29

Regulatory Status

Discontinued

2009
27 Jan
Discontinued Application: 77392

Drug Name

LAMOTRIGINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-01-27

77392 / 1

Active Ingredient

LAMOTRIGINE

Application Number

77392

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-01-27

Regulatory Status

Discontinued

2009
27 Jan
Discontinued Application: 77392

Drug Name

LAMOTRIGINE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2009-01-27

77392 / 2

Active Ingredient

LAMOTRIGINE

Application Number

77392

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2009-01-27

Regulatory Status

Discontinued

2009
27 Jan
Discontinued Application: 77392

Drug Name

LAMOTRIGINE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2009-01-27

77392 / 3

Active Ingredient

LAMOTRIGINE

Application Number

77392

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2009-01-27

Regulatory Status

Discontinued

2009
27 Jan
Discontinued Application: 77392

Drug Name

LAMOTRIGINE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-01-27

77392 / 4

Active Ingredient

LAMOTRIGINE

Application Number

77392

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-01-27

Regulatory Status

Discontinued

1991
27 Nov
Discontinued Application: 73080

Drug Name

LOPERAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1991-11-27

73080 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE

Application Number

73080

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1991-11-27

Regulatory Status

Discontinued

1997
18 Mar
Discontinued Application: 74648

Drug Name

LORAZEPAM

Product Number

1

Dosage Form

-

Strength

0.5MG/5ML

Approval Date

1997-03-18

74648 / 1

Active Ingredient

LORAZEPAM

Application Number

74648

Product Number

1

Dosage Form

-

Strength

0.5MG/5ML

Approval Date

1997-03-18

Regulatory Status

Discontinued

2006
19 Jul
Discontinued Application: 77925

Drug Name

MELOXICAM

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2006-07-19

77925 / 1

Active Ingredient

MELOXICAM

Application Number

77925

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2006-07-19

Regulatory Status

Discontinued

2006
19 Jul
Discontinued Application: 77925

Drug Name

MELOXICAM

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2006-07-19

77925 / 2

Active Ingredient

MELOXICAM

Application Number

77925

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2006-07-19

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84332

Drug Name

MEPROBAMATE

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1982-01-01

84332 / 1

Active Ingredient

MEPROBAMATE

Application Number

84332

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1995
28 Apr
Discontinued Application: 74081

Drug Name

METHADONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1995-04-28

74081 / 1

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

74081

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1995-04-28

Regulatory Status

Discontinued

1984
29 Feb
Discontinued Application: 88646

Drug Name

METHOCARBAMOL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1984-02-29

88646 / 1

Active Ingredient

METHOCARBAMOL

Application Number

88646

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1984-02-29

Regulatory Status

Discontinued

1984
29 Feb
Discontinued Application: 88647

Drug Name

METHOCARBAMOL

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

1984-02-29

88647 / 1

Active Ingredient

METHOCARBAMOL

Application Number

88647

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

1984-02-29

Regulatory Status

Discontinued

1986
25 Apr
Discontinued Application: 70192

Drug Name

METHYLDOPA

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1986-04-25

70192 / 1

Active Ingredient

METHYLDOPA

Application Number

70192

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1986-04-25

Regulatory Status

Discontinued

1986
25 Apr
Discontinued Application: 70193

Drug Name

METHYLDOPA

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1986-04-25

70193 / 1

Active Ingredient

METHYLDOPA

Application Number

70193

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1986-04-25

Regulatory Status

Discontinued

1986
25 Apr
Discontinued Application: 70194

Drug Name

METHYLDOPA

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1986-04-25

70194 / 1

Active Ingredient

METHYLDOPA

Application Number

70194

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1986-04-25

Regulatory Status

Discontinued

1988
05 Dec
Discontinued Application: 72038

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/5ML

Approval Date

1988-12-05

72038 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

72038

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/5ML

Approval Date

1988-12-05

Regulatory Status

Discontinued

1992
30 Jan
Discontinued Application: 72995

Drug Name

METOCLOPRAMIDE INTENSOL

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1992-01-30

72995 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

72995

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1992-01-30

Regulatory Status

Discontinued

-
Unclassified Application: 76482

Drug Name

METOLAZONE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

-

76482 / 1

Active Ingredient

METOLAZONE

Application Number

76482

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

2004
29 Apr
Discontinued Application: 76482

Drug Name

METOLAZONE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2004-04-29

76482 / 2

Active Ingredient

METOLAZONE

Application Number

76482

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2004-04-29

Regulatory Status

Discontinued

2003
19 Jun
Discontinued Application: 76270

Drug Name

MIRTAZAPINE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2003-06-19

76270 / 1

Active Ingredient

MIRTAZAPINE

Application Number

76270

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2003-06-19

Regulatory Status

Discontinued

2003
19 Jun
Discontinued Application: 76270

Drug Name

MIRTAZAPINE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2003-06-19

76270 / 2

Active Ingredient

MIRTAZAPINE

Application Number

76270

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2003-06-19

Regulatory Status

Discontinued

2003
19 Jun
Discontinued Application: 76270

Drug Name

MIRTAZAPINE

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2003-06-19

76270 / 3

Active Ingredient

MIRTAZAPINE

Application Number

76270

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2003-06-19

Regulatory Status

Discontinued

1994
28 Feb
Discontinued Application: 74211

Drug Name

NAPROXEN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1994-02-28

74211 / 1

Active Ingredient

NAPROXEN

Application Number

74211

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1994-02-28

Regulatory Status

Discontinued

1994
28 Feb
Discontinued Application: 74211

Drug Name

NAPROXEN

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

1994-02-28

74211 / 2

Active Ingredient

NAPROXEN

Application Number

74211

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

1994-02-28

Regulatory Status

Discontinued

1994
28 Feb
Discontinued Application: 74211

Drug Name

NAPROXEN

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1994-02-28

74211 / 3

Active Ingredient

NAPROXEN

Application Number

74211

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1994-02-28

Regulatory Status

Discontinued

1993
21 Dec
Discontinued Application: 74257

Drug Name

NAPROXEN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1993-12-21

74257 / 1

Active Ingredient

NAPROXEN SODIUM

Application Number

74257

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1993-12-21

Regulatory Status

Discontinued

1993
21 Dec
Discontinued Application: 74257

Drug Name

NAPROXEN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1993-12-21

74257 / 2

Active Ingredient

NAPROXEN SODIUM

Application Number

74257

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1993-12-21

Regulatory Status

Discontinued

2003
16 Sep
Discontinued Application: 76196

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-09-16

76196 / 1

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76196

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-09-16

Regulatory Status

Discontinued

2003
16 Sep
Discontinued Application: 76196

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2003-09-16

76196 / 2

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76196

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2003-09-16

Regulatory Status

Discontinued

2003
16 Sep
Discontinued Application: 76196

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2003-09-16

76196 / 3

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76196

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2003-09-16

Regulatory Status

Discontinued

2003
16 Sep
Discontinued Application: 76196

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2003-09-16

76196 / 4

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76196

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2003-09-16

Regulatory Status

Discontinued

2003
16 Sep
Discontinued Application: 76196

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

250MG

Approval Date

2003-09-16

76196 / 5

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76196

Product Number

5

Dosage Form

-

Strength

250MG

Approval Date

2003-09-16

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62173

Drug Name

NEOMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

62173 / 1

Active Ingredient

NEOMYCIN SULFATE

Application Number

62173

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

-
Unclassified Application: 77993

Drug Name

OLANZAPINE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

-

77993 / 1

Active Ingredient

OLANZAPINE

Application Number

77993

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

-

Regulatory Status

Unclassified

1993
09 Jul
Discontinued Application: 20315

Drug Name

ORLAAM

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1993-07-09

20315 / 1

Active Ingredient

LEVOMETHADYL ACETATE HYDROCHLORIDE

Application Number

20315

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1993-07-09

Regulatory Status

Discontinued

2007
10 Jul
Discontinued Application: 77249

Drug Name

OXANDROLONE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2007-07-10

77249 / 1

Active Ingredient

OXANDROLONE

Application Number

77249

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2007-07-10

Regulatory Status

Discontinued

2007
10 Jul
Discontinued Application: 77249

Drug Name

OXANDROLONE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-07-10

77249 / 2

Active Ingredient

OXANDROLONE

Application Number

77249

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-07-10

Regulatory Status

Discontinued

1982
04 Jun
Discontinued Application: 87742

Drug Name

OXYCODONE AND ASPIRIN (HALF-STRENGTH)

Product Number

1

Dosage Form

-

Strength

325MG;2.25MG;0.19MG

Approval Date

1982-06-04

87742 / 1

Active Ingredient

ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE

Application Number

87742

Product Number

1

Dosage Form

-

Strength

325MG;2.25MG;0.19MG

Approval Date

1982-06-04

Regulatory Status

Discontinued

2007
29 Jun
Discontinued Application: 78026

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-06-29

78026 / 1

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

78026

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-06-29

Regulatory Status

Discontinued

2007
29 Jun
Discontinued Application: 78026

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2007-06-29

78026 / 2

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

78026

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2007-06-29

Regulatory Status

Discontinued

2007
29 Jun
Discontinued Application: 78026

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2007-06-29

78026 / 3

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

78026

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2007-06-29

Regulatory Status

Discontinued

2007
29 Jun
Discontinued Application: 78026

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2007-06-29

78026 / 4

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

78026

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2007-06-29

Regulatory Status

Discontinued

1982
19 Feb
Discontinued Application: 18551

Drug Name

POTASSIUM IODIDE

Product Number

1

Dosage Form

-

Strength

1GM/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-02-19

18551 / 1

Active Ingredient

POTASSIUM IODIDE

Application Number

18551

Product Number

1

Dosage Form

-

Strength

1GM/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-02-19

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80327

Drug Name

PREDNISOLONE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

80327 / 2

Active Ingredient

PREDNISOLONE

Application Number

80327

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17109

Drug Name

PREDNISONE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

17109 / 1

Active Ingredient

PREDNISONE

Application Number

17109

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
04 May
Discontinued Application: 87833

Drug Name

PREDNISONE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-05-04

87833 / 1

Active Ingredient

PREDNISONE

Application Number

87833

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-05-04

Regulatory Status

Discontinued

1985
26 Apr
Discontinued Application: 88989

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1985-04-26

88989 / 1

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

88989

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1985-04-26

Regulatory Status

Discontinued

1985
26 Apr
Discontinued Application: 88990

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1985-04-26

88990 / 1

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

88990

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1985-04-26

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83089

Drug Name

PROPOXYPHENE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

32MG

Approval Date

1982-01-01

83089 / 1

Active Ingredient

PROPOXYPHENE HYDROCHLORIDE

Application Number

83089

Product Number

1

Dosage Form

-

Strength

32MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83089

Drug Name

PROPOXYPHENE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

65MG

Approval Date

1982-01-01

83089 / 2

Active Ingredient

PROPOXYPHENE HYDROCHLORIDE

Application Number

83089

Product Number

2

Dosage Form

-

Strength

65MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1986
07 Jul
Discontinued Application: 70516

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1986-07-07

70516 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

70516

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1986-07-07

Regulatory Status

Discontinued

1986
07 Jul
Discontinued Application: 70517

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1986-07-07

70517 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

70517

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1986-07-07

Regulatory Status

Discontinued

1986
07 Jul
Discontinued Application: 70518

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1986-07-07

70518 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

70518

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1986-07-07

Regulatory Status

Discontinued

1986
24 Sep
Discontinued Application: 70519

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

1986-09-24

70519 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

70519

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

1986-09-24

Regulatory Status

Discontinued

1986
07 Jul
Discontinued Application: 70520

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1986-07-07

70520 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

70520

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1986-07-07

Regulatory Status

Discontinued

1986
24 Sep
Discontinued Application: 70521

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

1986-09-24

70521 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

70521

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

1986-09-24

Regulatory Status

Discontinued

1987
15 May
Discontinued Application: 71388

Drug Name

PROPRANOLOL HYDROCHLORIDE INTENSOL

Product Number

1

Dosage Form

-

Strength

80MG/ML

Approval Date

1987-05-15

71388 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

71388

Product Number

1

Dosage Form

-

Strength

80MG/ML

Approval Date

1987-05-15

Regulatory Status

Discontinued

-
Unclassified Application: 78695

Drug Name

ROSIGLITAZONE MALEATE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

-

78695 / 1

Active Ingredient

ROSIGLITAZONE MALEATE

Application Number

78695

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

-

Regulatory Status

Unclassified

1989
12 Jan
Discontinued Application: 89775

Drug Name

ROXICET 5/500

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1989-01-12

89775 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

89775

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1989-01-12

Regulatory Status

Discontinued

1998
26 Oct
Discontinued Application: 20932

Drug Name

ROXICODONE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1998-10-26

20932 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

20932

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1998-10-26

Regulatory Status

Discontinued

1998
26 Oct
Discontinued Application: 20932

Drug Name

ROXICODONE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1998-10-26

20932 / 2

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

20932

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1998-10-26

Regulatory Status

Discontinued

1995
03 Jul
Discontinued Application: 40061

Drug Name

ROXILOX

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1995-07-03

40061 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

40061

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1995-07-03

Regulatory Status

Discontinued

1982
04 Jun
Discontinued Application: 87743

Drug Name

ROXIPRIN

Product Number

1

Dosage Form

-

Strength

325MG;4.5MG;0.38MG

Approval Date

1982-06-04

87743 / 1

Active Ingredient

ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE

Application Number

87743

Product Number

1

Dosage Form

-

Strength

325MG;4.5MG;0.38MG

Approval Date

1982-06-04

Regulatory Status

Discontinued

1983
17 Nov
Discontinued Application: 88453

Drug Name

SODIUM POLYSTYRENE SULFONATE

Product Number

1

Dosage Form

-

Strength

15GM/60ML

Approval Date

1983-11-17

88453 / 1

Active Ingredient

SODIUM POLYSTYRENE SULFONATE

Application Number

88453

Product Number

1

Dosage Form

-

Strength

15GM/60ML

Approval Date

1983-11-17

Regulatory Status

Discontinued

1991
30 Aug
Discontinued Application: 72768

Drug Name

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Product Number

1

Dosage Form

-

Strength

400MG;80MG

Approval Date

1991-08-30

72768 / 1

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

72768

Product Number

1

Dosage Form

-

Strength

400MG;80MG

Approval Date

1991-08-30

Regulatory Status

Discontinued

1991
30 Aug
Discontinued Application: 72769

Drug Name

SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH

Product Number

1

Dosage Form

-

Strength

800MG;160MG

Approval Date

1991-08-30

72769 / 1

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

72769

Product Number

1

Dosage Form

-

Strength

800MG;160MG

Approval Date

1991-08-30

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80082

Drug Name

SULFISOXAZOLE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

80082 / 1

Active Ingredient

SULFISOXAZOLE

Application Number

80082

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2009
10 Aug
Discontinued Application: 78241

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2009-08-10

78241 / 1

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

78241

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2009-08-10

Regulatory Status

Discontinued

2009
10 Aug
Discontinued Application: 78241

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2009-08-10

78241 / 2

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

78241

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2009-08-10

Regulatory Status

Discontinued

2009
10 Aug
Discontinued Application: 78241

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2009-08-10

78241 / 3

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

78241

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2009-08-10

Regulatory Status

Discontinued

2003
20 Feb
Discontinued Application: 76027

Drug Name

TAMOXIFEN CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2003-02-20

76027 / 1

Active Ingredient

TAMOXIFEN CITRATE

Application Number

76027

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2003-02-20

Regulatory Status

Discontinued

2003
20 Feb
Discontinued Application: 76027

Drug Name

TAMOXIFEN CITRATE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2003-02-20

76027 / 2

Active Ingredient

TAMOXIFEN CITRATE

Application Number

76027

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2003-02-20

Regulatory Status

Discontinued

2007
02 Jul
Discontinued Application: 77223

Drug Name

TERBINAFINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2007-07-02

77223 / 1

Active Ingredient

TERBINAFINE HYDROCHLORIDE

Application Number

77223

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2007-07-02

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61214

Drug Name

TETRACYCLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

61214 / 2

Active Ingredient

TETRACYCLINE HYDROCHLORIDE

Application Number

61214

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84739

Drug Name

THEOPHYLLINE

Product Number

1

Dosage Form

-

Strength

80MG/15ML

Approval Date

1982-01-01

84739 / 1

Active Ingredient

THEOPHYLLINE

Application Number

84739

Product Number

1

Dosage Form

-

Strength

80MG/15ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1983
15 Sep
Discontinued Application: 87449

Drug Name

THEOPHYLLINE

Product Number

1

Dosage Form

-

Strength

80MG/15ML

Approval Date

1983-09-15

87449 / 1

Active Ingredient

THEOPHYLLINE

Application Number

87449

Product Number

1

Dosage Form

-

Strength

80MG/15ML

Approval Date

1983-09-15

Regulatory Status

Discontinued

1984
15 Mar
Discontinued Application: 88663

Drug Name

THIORIDAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1984-03-15

88663 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

88663

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1984-03-15

Regulatory Status

Discontinued

1984
15 Mar
Discontinued Application: 88664

Drug Name

THIORIDAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1984-03-15

88664 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

88664

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1984-03-15

Regulatory Status

Discontinued

1984
15 Mar
Discontinued Application: 88665

Drug Name

THIORIDAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1984-03-15

88665 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

88665

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1984-03-15

Regulatory Status

Discontinued

1985
26 Feb
Discontinued Application: 89048

Drug Name

THIORIDAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1985-02-26

89048 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

89048

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1985-02-26

Regulatory Status

Discontinued

1985
16 Dec
Discontinued Application: 88941

Drug Name

THIORIDAZINE HYDROCHLORIDE INTENSOL

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

1985-12-16

88941 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

88941

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

1985-12-16

Regulatory Status

Discontinued

1985
16 Dec
Discontinued Application: 88942

Drug Name

THIORIDAZINE HYDROCHLORIDE INTENSOL

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1985-12-16

88942 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

88942

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1985-12-16

Regulatory Status

Discontinued

2009
27 Mar
Discontinued Application: 76306

Drug Name

TOPIRAMATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-03-27

76306 / 1

Active Ingredient

TOPIRAMATE

Application Number

76306

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-03-27

Regulatory Status

Discontinued

2009
27 Mar
Discontinued Application: 76306

Drug Name

TOPIRAMATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-03-27

76306 / 2

Active Ingredient

TOPIRAMATE

Application Number

76306

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-03-27

Regulatory Status

Discontinued

2009
27 Mar
Discontinued Application: 76306

Drug Name

TOPIRAMATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-03-27

76306 / 3

Active Ingredient

TOPIRAMATE

Application Number

76306

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-03-27

Regulatory Status

Discontinued

2009
27 Mar
Discontinued Application: 76306

Drug Name

TOPIRAMATE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-03-27

76306 / 4

Active Ingredient

TOPIRAMATE

Application Number

76306

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-03-27

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84707

Drug Name

TRIAMCINOLONE

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

1982-01-01

84707 / 1

Active Ingredient

TRIAMCINOLONE

Application Number

84707

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84708

Drug Name

TRIAMCINOLONE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

84708 / 1

Active Ingredient

TRIAMCINOLONE

Application Number

84708

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84709

Drug Name

TRIAMCINOLONE

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

84709 / 1

Active Ingredient

TRIAMCINOLONE

Application Number

84709

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2005
22 Dec
Discontinued Application: 77648

Drug Name

ZONISAMIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2005-12-22

77648 / 1

Active Ingredient

ZONISAMIDE

Application Number

77648

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2005-12-22

Regulatory Status

Discontinued

2005
22 Dec
Discontinued Application: 77648

Drug Name

ZONISAMIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2005-12-22

77648 / 2

Active Ingredient

ZONISAMIDE

Application Number

77648

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2005-12-22

Regulatory Status

Discontinued

2005
22 Dec
Discontinued Application: 77648

Drug Name

ZONISAMIDE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2005-12-22

77648 / 3

Active Ingredient

ZONISAMIDE

Application Number

77648

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2005-12-22

Regulatory Status

Discontinued

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Drug Status Breakdown
169 total
  • 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

ACETAMINOPHEN AND CODEINE PHOSPHATE

Application Number

84656

Product Number

1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Dosage Form

-

Strength

300MG;30MG

FDA Approved Drug Data

Approved drug product information

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