Taro Pharmaceutical Industries
FDA Approved Drugs

Taro Pharmaceutical Industries

FDA Approved Drugs Database

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

Discontinued OTC RX Unclassified
  • Total Records 209
  • Latest Approval Date Jun 15, 2026
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
209
View
Unclassified
1
View
Discontinued
83
View
OTC
17
View
RX
108
View
Company Overview

Company

Taro Pharmaceutical Industries

Country

U.S.A

Website

Visit Website

Email

enquiries@pharmacompass.com

Social Profiles

Company Snapshot

Taro Pharmaceutical Industries

Three Skyline Drive Hawthorne, NY 10532

U.S.A

www.taro.com/ enquiries@pharmacompass.com View on Map
FDA Approved Drug Records ( 209 records )
1982
18 Nov
Discontinued Application: 62405

Drug Name

A/T/S

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1982-11-18

62405 / 1

Active Ingredient

ERYTHROMYCIN

Application Number

62405

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1982-11-18

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18337

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

18337 / 1

Active Ingredient

ACETAMINOPHEN

Application Number

18337

Product Number

1

Dosage Form

-

Strength

650MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
OTC Application: 18337

Drug Name

ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG

Approval Date

1982-01-01

18337 / 2

Active Ingredient

ACETAMINOPHEN

Application Number

18337

Product Number

2

Dosage Form

-

Strength

325MG

Approval Date

1982-01-01

Regulatory Status

OTC

1983
12 Sep
OTC Application: 18337

Drug Name

ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

1983-09-12

18337 / 3

Active Ingredient

ACETAMINOPHEN

Application Number

18337

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

1983-09-12

Regulatory Status

OTC

2026
02 Jan
OTC Application: 219053

Drug Name

ACETAMINOPHEN AND IBUPROFEN

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

2026-01-02

219053 / 1

Active Ingredient

ACETAMINOPHEN; IBUPROFEN

Application Number

219053

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

2026-01-02

Regulatory Status

OTC

1997
28 May
RX Application: 40195

Drug Name

ACETAZOLAMIDE

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1997-05-28

40195 / 1

Active Ingredient

ACETAZOLAMIDE

Application Number

40195

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1997-05-28

Regulatory Status

RX

1997
28 May
RX Application: 40195

Drug Name

ACETAZOLAMIDE

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

1997-05-28

40195 / 2

Active Ingredient

ACETAZOLAMIDE

Application Number

40195

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

1997-05-28

Regulatory Status

RX

2023
24 Mar
Discontinued Application: 214458

Drug Name

AMINOCAPROIC ACID

Product Number

1

Dosage Form

-

Strength

0.25GM/ML

Approval Date

2023-03-24

214458 / 1

Active Ingredient

AMINOCAPROIC ACID

Application Number

214458

Product Number

1

Dosage Form

-

Strength

0.25GM/ML

Approval Date

2023-03-24

Regulatory Status

Discontinued

2001
30 Mar
RX Application: 75424

Drug Name

AMIODARONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2001-03-30

75424 / 1

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

75424

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2001-03-30

Regulatory Status

RX

2002
18 Dec
RX Application: 75424

Drug Name

AMIODARONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2002-12-18

75424 / 2

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

75424

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2002-12-18

Regulatory Status

RX

2002
29 Nov
Discontinued Application: 76362

Drug Name

AMIODARONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2002-11-29

76362 / 1

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

76362

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2002-11-29

Regulatory Status

Discontinued

2003
02 Dec
Discontinued Application: 76362

Drug Name

AMIODARONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2003-12-02

76362 / 2

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

76362

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2003-12-02

Regulatory Status

Discontinued

2019
11 Dec
Discontinued Application: 211521

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

2019-12-11

211521 / 1

Active Ingredient

AZITHROMYCIN

Application Number

211521

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

2019-12-11

Regulatory Status

Discontinued

2017
24 May
RX Application: 208204

Drug Name

BETAMETHASONE VALERATE

Product Number

1

Dosage Form

-

Strength

0.12%

Approval Date

2017-05-24

208204 / 1

Active Ingredient

BETAMETHASONE VALERATE

Application Number

208204

Product Number

1

Dosage Form

-

Strength

0.12%

Approval Date

2017-05-24

Regulatory Status

RX

2017
27 Feb
Discontinued Application: 205112

Drug Name

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

2MG/5ML;10MG/5ML;30MG/5ML

Approval Date

2017-02-27

205112 / 1

Active Ingredient

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

205112

Product Number

1

Dosage Form

-

Strength

2MG/5ML;10MG/5ML;30MG/5ML

Approval Date

2017-02-27

Regulatory Status

Discontinued

2023
24 Jul
RX Application: 213458

Drug Name

BUMETANIDE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2023-07-24

213458 / 1

Active Ingredient

BUMETANIDE

Application Number

213458

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2023-07-24

Regulatory Status

RX

2023
24 Jul
RX Application: 213458

Drug Name

BUMETANIDE

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2023-07-24

213458 / 2

Active Ingredient

BUMETANIDE

Application Number

213458

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2023-07-24

Regulatory Status

RX

2023
24 Jul
RX Application: 213458

Drug Name

BUMETANIDE

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2023-07-24

213458 / 3

Active Ingredient

BUMETANIDE

Application Number

213458

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2023-07-24

Regulatory Status

RX

2020
01 Jul
RX Application: 213046

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

300MG;50MG;40MG

Approval Date

2020-07-01

213046 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Application Number

213046

Product Number

1

Dosage Form

-

Strength

300MG;50MG;40MG

Approval Date

2020-07-01

Regulatory Status

RX

1996
03 Oct
RX Application: 74649

Drug Name

CARBAMAZEPINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1996-10-03

74649 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

74649

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1996-10-03

Regulatory Status

RX

2000
21 Dec
Discontinued Application: 75875

Drug Name

CARBAMAZEPINE

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2000-12-21

75875 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

75875

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2000-12-21

Regulatory Status

Discontinued

2009
31 Mar
RX Application: 78115

Drug Name

CARBAMAZEPINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2009-03-31

78115 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

78115

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2009-03-31

Regulatory Status

RX

2009
31 Mar
RX Application: 78115

Drug Name

CARBAMAZEPINE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2009-03-31

78115 / 2

Active Ingredient

CARBAMAZEPINE

Application Number

78115

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2009-03-31

Regulatory Status

RX

2009
31 Mar
RX Application: 78115

Drug Name

CARBAMAZEPINE

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2009-03-31

78115 / 3

Active Ingredient

CARBAMAZEPINE

Application Number

78115

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2009-03-31

Regulatory Status

RX

2013
21 Jun
Discontinued Application: 201106

Drug Name

CARBAMAZEPINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2013-06-21

201106 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

201106

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2013-06-21

Regulatory Status

Discontinued

2013
21 Jun
Discontinued Application: 201106

Drug Name

CARBAMAZEPINE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2013-06-21

201106 / 2

Active Ingredient

CARBAMAZEPINE

Application Number

201106

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2013-06-21

Regulatory Status

Discontinued

2013
21 Jun
Discontinued Application: 201106

Drug Name

CARBAMAZEPINE

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2013-06-21

201106 / 3

Active Ingredient

CARBAMAZEPINE

Application Number

201106

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2013-06-21

Regulatory Status

Discontinued

2007
05 Sep
Discontinued Application: 77780

Drug Name

CARVEDILOL

Product Number

1

Dosage Form

-

Strength

3.125MG

Approval Date

2007-09-05

77780 / 1

Active Ingredient

CARVEDILOL

Application Number

77780

Product Number

1

Dosage Form

-

Strength

3.125MG

Approval Date

2007-09-05

Regulatory Status

Discontinued

2007
05 Sep
Discontinued Application: 77780

Drug Name

CARVEDILOL

Product Number

2

Dosage Form

-

Strength

6.25MG

Approval Date

2007-09-05

77780 / 2

Active Ingredient

CARVEDILOL

Application Number

77780

Product Number

2

Dosage Form

-

Strength

6.25MG

Approval Date

2007-09-05

Regulatory Status

Discontinued

2007
05 Sep
Discontinued Application: 77780

Drug Name

CARVEDILOL

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2007-09-05

77780 / 3

Active Ingredient

CARVEDILOL

Application Number

77780

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2007-09-05

Regulatory Status

Discontinued

2007
05 Sep
Discontinued Application: 77780

Drug Name

CARVEDILOL

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2007-09-05

77780 / 4

Active Ingredient

CARVEDILOL

Application Number

77780

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2007-09-05

Regulatory Status

Discontinued

2008
20 Jun
RX Application: 76601

Drug Name

CETIRIZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2008-06-20

76601 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

76601

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2008-06-20

Regulatory Status

RX

2009
22 Jul
Discontinued Application: 78072

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-07-22

78072 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

78072

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-07-22

Regulatory Status

Discontinued

2009
22 Jul
Discontinued Application: 78072

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2009-07-22

78072 / 3

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

78072

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2009-07-22

Regulatory Status

Discontinued

2009
22 Jul
Discontinued Application: 78072

Drug Name

CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2009-07-22

78072 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

78072

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2009-07-22

Regulatory Status

Discontinued

2009
22 Jul
Discontinued Application: 78072

Drug Name

CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2009-07-22

78072 / 4

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

78072

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2009-07-22

Regulatory Status

Discontinued

2008
22 Apr
OTC Application: 90182

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

2

Dosage Form

-

Strength

5MG/5ML

Approval Date

2008-04-22

90182 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

90182

Product Number

2

Dosage Form

-

Strength

5MG/5ML

Approval Date

2008-04-22

Regulatory Status

OTC

2011
20 May
OTC Application: 201546

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2011-05-20

201546 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

201546

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2011-05-20

Regulatory Status

OTC

2008
22 Apr
OTC Application: 90182

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2008-04-22

90182 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

90182

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2008-04-22

Regulatory Status

OTC

2011
20 May
OTC Application: 201546

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Product Number

2

Dosage Form

-

Strength

5MG/5ML

Approval Date

2011-05-20

201546 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

201546

Product Number

2

Dosage Form

-

Strength

5MG/5ML

Approval Date

2011-05-20

Regulatory Status

OTC

2017
09 Nov
OTC Application: 208123

Drug Name

CHILDRENS FEXOFENADINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

30MG/5ML

Approval Date

2017-11-09

208123 / 1

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

208123

Product Number

1

Dosage Form

-

Strength

30MG/5ML

Approval Date

2017-11-09

Regulatory Status

OTC

2017
09 Nov
OTC Application: 208123

Drug Name

CHILDRENS FEXOFENADINE HYDROCHLORIDE HIVES

Product Number

2

Dosage Form

-

Strength

30MG/5ML

Approval Date

2017-11-09

208123 / 2

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

208123

Product Number

2

Dosage Form

-

Strength

30MG/5ML

Approval Date

2017-11-09

Regulatory Status

OTC

2004
06 Oct
Discontinued Application: 76912

Drug Name

CIPROFLOXACIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2004-10-06

76912 / 2

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

76912

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2004-10-06

Regulatory Status

Discontinued

2004
06 Oct
Discontinued Application: 76912

Drug Name

CIPROFLOXACIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2004-10-06

76912 / 3

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

76912

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2004-10-06

Regulatory Status

Discontinued

2004
06 Oct
Discontinued Application: 76912

Drug Name

CIPROFLOXACIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2004-10-06

76912 / 4

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

76912

Product Number

4

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2004-10-06

Regulatory Status

Discontinued

2006
22 Mar
Discontinued Application: 77278

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2006-03-22

77278 / 1

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77278

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2006-03-22

Regulatory Status

Discontinued

2006
22 Mar
Discontinued Application: 77278

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2006-03-22

77278 / 2

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77278

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2006-03-22

Regulatory Status

Discontinued

2006
22 Mar
Discontinued Application: 77278

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2006-03-22

77278 / 3

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77278

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2006-03-22

Regulatory Status

Discontinued

2020
11 Mar
RX Application: 210004

Drug Name

CLINDAMYCIN PHOSPHATE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2020-03-11

210004 / 1

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

210004

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2020-03-11

Regulatory Status

RX

2018
22 Oct
Discontinued Application: 209440

Drug Name

CLOBAZAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-10-22

209440 / 1

Active Ingredient

CLOBAZAM

Application Number

209440

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-10-22

Regulatory Status

Discontinued

2018
22 Oct
Discontinued Application: 209440

Drug Name

CLOBAZAM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-10-22

209440 / 2

Active Ingredient

CLOBAZAM

Application Number

209440

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-10-22

Regulatory Status

Discontinued

2019
15 Apr
RX Application: 210978

Drug Name

CLOBAZAM

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2019-04-15

210978 / 1

Active Ingredient

CLOBAZAM

Application Number

210978

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2019-04-15

Regulatory Status

RX

2024
14 Mar
Discontinued Application: 208563

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2024-03-14

208563 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

208563

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2024-03-14

Regulatory Status

Discontinued

2018
04 Oct
RX Application: 208779

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2018-10-04

208779 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

208779

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2018-10-04

Regulatory Status

RX

2020
21 Apr
RX Application: 206370

Drug Name

CLOCORTOLONE PIVALATE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2020-04-21

206370 / 1

Active Ingredient

CLOCORTOLONE PIVALATE

Application Number

206370

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2020-04-21

Regulatory Status

RX

1996
31 Dec
RX Application: 74694

Drug Name

CLOMIPRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1996-12-31

74694 / 1

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

74694

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1996-12-31

Regulatory Status

RX

1996
31 Dec
RX Application: 74694

Drug Name

CLOMIPRAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1996-12-31

74694 / 2

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

74694

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1996-12-31

Regulatory Status

RX

1996
31 Dec
RX Application: 74694

Drug Name

CLOMIPRAMINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1996-12-31

74694 / 3

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

74694

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1996-12-31

Regulatory Status

RX

2000
27 Apr
RX Application: 75731

Drug Name

CLORAZEPATE DIPOTASSIUM

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2000-04-27

75731 / 1

Active Ingredient

CLORAZEPATE DIPOTASSIUM

Application Number

75731

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2000-04-27

Regulatory Status

RX

2000
27 Apr
RX Application: 75731

Drug Name

CLORAZEPATE DIPOTASSIUM

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2000-04-27

75731 / 2

Active Ingredient

CLORAZEPATE DIPOTASSIUM

Application Number

75731

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2000-04-27

Regulatory Status

RX

2000
27 Apr
RX Application: 75731

Drug Name

CLORAZEPATE DIPOTASSIUM

Product Number

3

Dosage Form

-

Strength

3.75MG

Approval Date

2000-04-27

75731 / 3

Active Ingredient

CLORAZEPATE DIPOTASSIUM

Application Number

75731

Product Number

3

Dosage Form

-

Strength

3.75MG

Approval Date

2000-04-27

Regulatory Status

RX

2001
29 May
RX Application: 75673

Drug Name

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE;1%

Approval Date

2001-05-29

75673 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE

Application Number

75673

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE;1%

Approval Date

2001-05-29

Regulatory Status

RX

2019
01 Mar
Discontinued Application: 209430

Drug Name

DAPSONE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-03-01

209430 / 1

Active Ingredient

DAPSONE

Application Number

209430

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-03-01

Regulatory Status

Discontinued

2019
01 Mar
Discontinued Application: 209430

Drug Name

DAPSONE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2019-03-01

209430 / 2

Active Ingredient

DAPSONE

Application Number

209430

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2019-03-01

Regulatory Status

Discontinued

2019
08 Feb
RX Application: 208800

Drug Name

DEFERIPRONE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2019-02-08

208800 / 1

Active Ingredient

DEFERIPRONE

Application Number

208800

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2019-02-08

Regulatory Status

RX

2023
22 Nov
RX Application: 208800

Drug Name

DEFERIPRONE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2023-11-22

208800 / 2

Active Ingredient

DEFERIPRONE

Application Number

208800

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2023-11-22

Regulatory Status

RX

2015
30 Jun
Discontinued Application: 202592

Drug Name

DESLORATADINE

Product Number

1

Dosage Form

-

Strength

0.5MG/ML

Approval Date

2015-06-30

202592 / 1

Active Ingredient

DESLORATADINE

Application Number

202592

Product Number

1

Dosage Form

-

Strength

0.5MG/ML

Approval Date

2015-06-30

Regulatory Status

Discontinued

2016
26 May
RX Application: 202936

Drug Name

DESLORATADINE

Product Number

1

Dosage Form

-

Strength

0.5MG/ML

Approval Date

2016-05-26

202936 / 1

Active Ingredient

DESLORATADINE

Application Number

202936

Product Number

1

Dosage Form

-

Strength

0.5MG/ML

Approval Date

2016-05-26

Regulatory Status

RX

2014
31 Oct
RX Application: 202161

Drug Name

DESONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2014-10-31

202161 / 1

Active Ingredient

DESONIDE

Application Number

202161

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2014-10-31

Regulatory Status

RX

2024
14 Jun
RX Application: 218011

Drug Name

DICLOFENAC POTASSIUM

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2024-06-14

218011 / 1

Active Ingredient

DICLOFENAC POTASSIUM

Application Number

218011

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2024-06-14

Regulatory Status

RX

2020
01 Jul
Discontinued Application: 213063

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2020-07-01

213063 / 1

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

213063

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2020-07-01

Regulatory Status

Discontinued

2020
01 Jul
Discontinued Application: 213063

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2020-07-01

213063 / 2

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

213063

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2020-07-01

Regulatory Status

Discontinued

2020
01 Jul
Discontinued Application: 213063

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2020-07-01

213063 / 3

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

213063

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2020-07-01

Regulatory Status

Discontinued

2020
01 Jul
Discontinued Application: 213063

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2020-07-01

213063 / 4

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

213063

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2020-07-01

Regulatory Status

Discontinued

2020
01 Jul
Discontinued Application: 213063

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2020-07-01

213063 / 5

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

213063

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2020-07-01

Regulatory Status

Discontinued

2025
06 Aug
RX Application: 219058

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2025-08-06

219058 / 1

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

219058

Product Number

1

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2025-08-06

Regulatory Status

RX

2025
06 Aug
RX Application: 219058

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2025-08-06

219058 / 2

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

219058

Product Number

2

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2025-08-06

Regulatory Status

RX

2001
23 Jan
RX Application: 75657

Drug Name

ENALAPRIL MALEATE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2001-01-23

75657 / 1

Active Ingredient

ENALAPRIL MALEATE

Application Number

75657

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2001-01-23

Regulatory Status

RX

2001
23 Jan
RX Application: 75657

Drug Name

ENALAPRIL MALEATE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2001-01-23

75657 / 2

Active Ingredient

ENALAPRIL MALEATE

Application Number

75657

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2001-01-23

Regulatory Status

RX

2001
23 Jan
RX Application: 75657

Drug Name

ENALAPRIL MALEATE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2001-01-23

75657 / 3

Active Ingredient

ENALAPRIL MALEATE

Application Number

75657

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2001-01-23

Regulatory Status

RX

2001
23 Jan
RX Application: 75657

Drug Name

ENALAPRIL MALEATE

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2001-01-23

75657 / 4

Active Ingredient

ENALAPRIL MALEATE

Application Number

75657

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2001-01-23

Regulatory Status

RX

1998
30 Apr
RX Application: 75078

Drug Name

ETODOLAC

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1998-04-30

75078 / 1

Active Ingredient

ETODOLAC

Application Number

75078

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1998-04-30

Regulatory Status

RX

1998
30 Apr
RX Application: 75078

Drug Name

ETODOLAC

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1998-04-30

75078 / 2

Active Ingredient

ETODOLAC

Application Number

75078

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1998-04-30

Regulatory Status

RX

2003
13 Mar
RX Application: 76174

Drug Name

ETODOLAC

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2003-03-13

76174 / 1

Active Ingredient

ETODOLAC

Application Number

76174

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2003-03-13

Regulatory Status

RX

2003
13 Mar
RX Application: 76174

Drug Name

ETODOLAC

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2003-03-13

76174 / 2

Active Ingredient

ETODOLAC

Application Number

76174

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2003-03-13

Regulatory Status

RX

2003
13 Mar
RX Application: 76174

Drug Name

ETODOLAC

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2003-03-13

76174 / 3

Active Ingredient

ETODOLAC

Application Number

76174

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2003-03-13

Regulatory Status

RX

2006
05 Sep
RX Application: 40684

Drug Name

EXTENDED PHENYTOIN SODIUM

Product Number

1

Dosage Form

-

Strength

100MG EXTENDED

Approval Date

2006-09-05

40684 / 1

Active Ingredient

PHENYTOIN SODIUM

Application Number

40684

Product Number

1

Dosage Form

-

Strength

100MG EXTENDED

Approval Date

2006-09-05

Regulatory Status

RX

2017
16 Jun
RX Application: 206314

Drug Name

FELBAMATE

Product Number

1

Dosage Form

-

Strength

600MG/5ML

Approval Date

2017-06-16

206314 / 1

Active Ingredient

FELBAMATE

Application Number

206314

Product Number

1

Dosage Form

-

Strength

600MG/5ML

Approval Date

2017-06-16

Regulatory Status

RX

2017
20 Apr
RX Application: 207093

Drug Name

FELBAMATE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2017-04-20

207093 / 1

Active Ingredient

FELBAMATE

Application Number

207093

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2017-04-20

Regulatory Status

RX

2017
20 Apr
RX Application: 207093

Drug Name

FELBAMATE

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2017-04-20

207093 / 2

Active Ingredient

FELBAMATE

Application Number

207093

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2017-04-20

Regulatory Status

RX

2004
29 Jul
Discontinued Application: 76507

Drug Name

FLUCONAZOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-07-29

76507 / 1

Active Ingredient

FLUCONAZOLE

Application Number

76507

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76507

Drug Name

FLUCONAZOLE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2004-07-29

76507 / 2

Active Ingredient

FLUCONAZOLE

Application Number

76507

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76507

Drug Name

FLUCONAZOLE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2004-07-29

76507 / 3

Active Ingredient

FLUCONAZOLE

Application Number

76507

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76507

Drug Name

FLUCONAZOLE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2004-07-29

76507 / 4

Active Ingredient

FLUCONAZOLE

Application Number

76507

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

1989
19 Jan
RX Application: 72494

Drug Name

FLUOCINONIDE EMULSIFIED BASE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1989-01-19

72494 / 1

Active Ingredient

FLUOCINONIDE

Application Number

72494

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1989-01-19

Regulatory Status

RX

2003
05 Nov
RX Application: 76526

Drug Name

FLUOROURACIL

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2003-11-05

76526 / 1

Active Ingredient

FLUOROURACIL

Application Number

76526

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2003-11-05

Regulatory Status

RX

2003
05 Nov
RX Application: 76526

Drug Name

FLUOROURACIL

Product Number

2

Dosage Form

-

Strength

5%

Approval Date

2003-11-05

76526 / 2

Active Ingredient

FLUOROURACIL

Application Number

76526

Product Number

2

Dosage Form

-

Strength

5%

Approval Date

2003-11-05

Regulatory Status

RX

2010
05 Mar
RX Application: 90368

Drug Name

FLUOROURACIL

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2010-03-05

90368 / 1

Active Ingredient

FLUOROURACIL

Application Number

90368

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2010-03-05

Regulatory Status

RX

2022
14 Apr
RX Application: 215674

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2022-04-14

215674 / 1

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

215674

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2022-04-14

Regulatory Status

RX

2022
14 Apr
RX Application: 215674

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2022-04-14

215674 / 2

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

215674

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2022-04-14

Regulatory Status

RX

2022
14 Apr
RX Application: 215674

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2022-04-14

215674 / 3

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

215674

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2022-04-14

Regulatory Status

RX

2022
14 Apr
RX Application: 215674

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2022-04-14

215674 / 4

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

215674

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2022-04-14

Regulatory Status

RX

2013
03 Jul
Discontinued Application: 76672

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

250MG/5ML

Approval Date

2013-07-03

76672 / 1

Active Ingredient

GABAPENTIN

Application Number

76672

Product Number

1

Dosage Form

-

Strength

250MG/5ML

Approval Date

2013-07-03

Regulatory Status

Discontinued

2013
02 Aug
Discontinued Application: 77261

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2013-08-02

77261 / 1

Active Ingredient

GABAPENTIN

Application Number

77261

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2013-08-02

Regulatory Status

Discontinued

2013
02 Aug
Discontinued Application: 77261

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2013-08-02

77261 / 2

Active Ingredient

GABAPENTIN

Application Number

77261

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2013-08-02

Regulatory Status

Discontinued

2013
02 Aug
Discontinued Application: 77261

Drug Name

GABAPENTIN

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2013-08-02

77261 / 3

Active Ingredient

GABAPENTIN

Application Number

77261

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2013-08-02

Regulatory Status

Discontinued

2010
28 May
Discontinued Application: 90817

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2010-05-28

90817 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

90817

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2010-05-28

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86154

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

86154 / 1

Active Ingredient

HYDROCORTISONE

Application Number

86154

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86155

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

86155 / 1

Active Ingredient

HYDROCORTISONE

Application Number

86155

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86256

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

86256 / 1

Active Ingredient

HYDROCORTISONE

Application Number

86256

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
09 Nov
RX Application: 88799

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

1984-11-09

88799 / 1

Active Ingredient

HYDROCORTISONE

Application Number

88799

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

1984-11-09

Regulatory Status

RX

1986
12 Feb
Discontinued Application: 89024

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1986-02-12

89024 / 1

Active Ingredient

HYDROCORTISONE

Application Number

89024

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1986-02-12

Regulatory Status

Discontinued

1985
04 Mar
RX Application: 88759

Drug Name

HYDROCORTISONE AND ACETIC ACID

Product Number

1

Dosage Form

-

Strength

2%;1%

Approval Date

1985-03-04

88759 / 1

Active Ingredient

ACETIC ACID, GLACIAL; HYDROCORTISONE

Application Number

88759

Product Number

1

Dosage Form

-

Strength

2%;1%

Approval Date

1985-03-04

Regulatory Status

RX

2004
27 Dec
RX Application: 76842

Drug Name

HYDROCORTISONE BUTYRATE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2004-12-27

76842 / 1

Active Ingredient

HYDROCORTISONE BUTYRATE

Application Number

76842

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2004-12-27

Regulatory Status

RX

2019
22 Jul
Discontinued Application: 207098

Drug Name

ILOPERIDONE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2019-07-22

207098 / 1

Active Ingredient

ILOPERIDONE

Application Number

207098

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2019-07-22

Regulatory Status

Discontinued

2019
22 Jul
Discontinued Application: 207098

Drug Name

ILOPERIDONE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2019-07-22

207098 / 2

Active Ingredient

ILOPERIDONE

Application Number

207098

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2019-07-22

Regulatory Status

Discontinued

2019
22 Jul
Discontinued Application: 207098

Drug Name

ILOPERIDONE

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2019-07-22

207098 / 3

Active Ingredient

ILOPERIDONE

Application Number

207098

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2019-07-22

Regulatory Status

Discontinued

2019
22 Jul
Discontinued Application: 207098

Drug Name

ILOPERIDONE

Product Number

4

Dosage Form

-

Strength

6MG

Approval Date

2019-07-22

207098 / 4

Active Ingredient

ILOPERIDONE

Application Number

207098

Product Number

4

Dosage Form

-

Strength

6MG

Approval Date

2019-07-22

Regulatory Status

Discontinued

2019
22 Jul
Discontinued Application: 207098

Drug Name

ILOPERIDONE

Product Number

5

Dosage Form

-

Strength

8MG

Approval Date

2019-07-22

207098 / 5

Active Ingredient

ILOPERIDONE

Application Number

207098

Product Number

5

Dosage Form

-

Strength

8MG

Approval Date

2019-07-22

Regulatory Status

Discontinued

2019
22 Jul
Discontinued Application: 207098

Drug Name

ILOPERIDONE

Product Number

6

Dosage Form

-

Strength

10MG

Approval Date

2019-07-22

207098 / 6

Active Ingredient

ILOPERIDONE

Application Number

207098

Product Number

6

Dosage Form

-

Strength

10MG

Approval Date

2019-07-22

Regulatory Status

Discontinued

2019
22 Jul
Discontinued Application: 207098

Drug Name

ILOPERIDONE

Product Number

7

Dosage Form

-

Strength

12MG

Approval Date

2019-07-22

207098 / 7

Active Ingredient

ILOPERIDONE

Application Number

207098

Product Number

7

Dosage Form

-

Strength

12MG

Approval Date

2019-07-22

Regulatory Status

Discontinued

2011
15 Apr
RX Application: 200173

Drug Name

IMIQUIMOD

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2011-04-15

200173 / 1

Active Ingredient

IMIQUIMOD

Application Number

200173

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2011-04-15

Regulatory Status

RX

2021
26 Jan
RX Application: 205971

Drug Name

IMIQUIMOD

Product Number

1

Dosage Form

-

Strength

3.75%

Approval Date

2021-01-26

205971 / 1

Active Ingredient

IMIQUIMOD

Application Number

205971

Product Number

1

Dosage Form

-

Strength

3.75%

Approval Date

2021-01-26

Regulatory Status

RX

1992
26 Aug
OTC Application: 18337

Drug Name

INFANTS FEVERALL

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

1992-08-26

18337 / 4

Active Ingredient

ACETAMINOPHEN

Application Number

18337

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

1992-08-26

Regulatory Status

OTC

2020
06 May
OTC Application: 210720

Drug Name

IVERMECTIN

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2020-05-06

210720 / 1

Active Ingredient

IVERMECTIN

Application Number

210720

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2020-05-06

Regulatory Status

OTC

1999
15 Jun
RX Application: 75319

Drug Name

KETOCONAZOLE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1999-06-15

75319 / 1

Active Ingredient

KETOCONAZOLE

Application Number

75319

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1999-06-15

Regulatory Status

RX

2024
13 Dec
RX Application: 218858

Drug Name

LACTULOSE

Product Number

1

Dosage Form

-

Strength

10GM/15ML

Approval Date

2024-12-13

218858 / 1

Active Ingredient

LACTULOSE

Application Number

218858

Product Number

1

Dosage Form

-

Strength

10GM/15ML

Approval Date

2024-12-13

Regulatory Status

RX

2009
04 Feb
Discontinued Application: 79204

Drug Name

LAMOTRIGINE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-02-04

79204 / 1

Active Ingredient

LAMOTRIGINE

Application Number

79204

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-02-04

Regulatory Status

Discontinued

2009
04 Feb
Discontinued Application: 79204

Drug Name

LAMOTRIGINE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2009-02-04

79204 / 2

Active Ingredient

LAMOTRIGINE

Application Number

79204

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2009-02-04

Regulatory Status

Discontinued

2025
07 Oct
RX Application: 219677

Drug Name

LAMOTRIGINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2025-10-07

219677 / 1

Active Ingredient

LAMOTRIGINE

Application Number

219677

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2025-10-07

Regulatory Status

RX

2025
07 Oct
RX Application: 219677

Drug Name

LAMOTRIGINE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2025-10-07

219677 / 2

Active Ingredient

LAMOTRIGINE

Application Number

219677

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2025-10-07

Regulatory Status

RX

2025
07 Oct
RX Application: 219677

Drug Name

LAMOTRIGINE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2025-10-07

219677 / 3

Active Ingredient

LAMOTRIGINE

Application Number

219677

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2025-10-07

Regulatory Status

RX

2025
07 Oct
RX Application: 219677

Drug Name

LAMOTRIGINE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2025-10-07

219677 / 4

Active Ingredient

LAMOTRIGINE

Application Number

219677

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2025-10-07

Regulatory Status

RX

2009
10 Feb
RX Application: 78774

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2009-02-10

78774 / 1

Active Ingredient

LEVETIRACETAM

Application Number

78774

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2009-02-10

Regulatory Status

RX

2010
01 Feb
Discontinued Application: 78960

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2010-02-01

78960 / 1

Active Ingredient

LEVETIRACETAM

Application Number

78960

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2010-02-01

Regulatory Status

Discontinued

2010
01 Feb
Discontinued Application: 78960

Drug Name

LEVETIRACETAM

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2010-02-01

78960 / 2

Active Ingredient

LEVETIRACETAM

Application Number

78960

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2010-02-01

Regulatory Status

Discontinued

2010
01 Feb
Discontinued Application: 78960

Drug Name

LEVETIRACETAM

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2010-02-01

78960 / 3

Active Ingredient

LEVETIRACETAM

Application Number

78960

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2010-02-01

Regulatory Status

Discontinued

2010
01 Feb
Discontinued Application: 78960

Drug Name

LEVETIRACETAM

Product Number

4

Dosage Form

-

Strength

250MG

Approval Date

2010-02-01

78960 / 4

Active Ingredient

LEVETIRACETAM

Application Number

78960

Product Number

4

Dosage Form

-

Strength

250MG

Approval Date

2010-02-01

Regulatory Status

Discontinued

2013
26 Jul
Discontinued Application: 202673

Drug Name

LEVOCETIRIZINE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG/5ML

Approval Date

2013-07-26

202673 / 1

Active Ingredient

LEVOCETIRIZINE DIHYDROCHLORIDE

Application Number

202673

Product Number

1

Dosage Form

-

Strength

2.5MG/5ML

Approval Date

2013-07-26

Regulatory Status

Discontinued

2004
20 Aug
OTC Application: 76805

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2004-08-20

76805 / 1

Active Ingredient

LORATADINE

Application Number

76805

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2004-08-20

Regulatory Status

OTC

2015
31 Jul
OTC Application: 201865

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2015-07-31

201865 / 1

Active Ingredient

LORATADINE

Application Number

201865

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2015-07-31

Regulatory Status

OTC

2006
07 Nov
Discontinued Application: 78102

Drug Name

MELOXICAM

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2006-11-07

78102 / 1

Active Ingredient

MELOXICAM

Application Number

78102

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2006-11-07

Regulatory Status

Discontinued

2006
07 Nov
Discontinued Application: 78102

Drug Name

MELOXICAM

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2006-11-07

78102 / 2

Active Ingredient

MELOXICAM

Application Number

78102

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2006-11-07

Regulatory Status

Discontinued

2011
23 May
Discontinued Application: 200998

Drug Name

MEPROBAMATE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2011-05-23

200998 / 1

Active Ingredient

MEPROBAMATE

Application Number

200998

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2011-05-23

Regulatory Status

Discontinued

2011
23 May
Discontinued Application: 200998

Drug Name

MEPROBAMATE

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2011-05-23

200998 / 2

Active Ingredient

MEPROBAMATE

Application Number

200998

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2011-05-23

Regulatory Status

Discontinued

2006
18 Jul
RX Application: 77819

Drug Name

METRONIDAZOLE

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

2006-07-18

77819 / 1

Active Ingredient

METRONIDAZOLE

Application Number

77819

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

2006-07-18

Regulatory Status

RX

2017
14 Mar
RX Application: 204651

Drug Name

METRONIDAZOLE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2017-03-14

204651 / 1

Active Ingredient

METRONIDAZOLE

Application Number

204651

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2017-03-14

Regulatory Status

RX

2018
31 Dec
OTC Application: 209074

Drug Name

MINOXIDIL (FOR MEN)

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2018-12-31

209074 / 1

Active Ingredient

MINOXIDIL

Application Number

209074

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2018-12-31

Regulatory Status

OTC

2019
22 Apr
OTC Application: 209074

Drug Name

MINOXIDIL (FOR WOMEN)

Product Number

2

Dosage Form

-

Strength

5%

Approval Date

2019-04-22

209074 / 2

Active Ingredient

MINOXIDIL

Application Number

209074

Product Number

2

Dosage Form

-

Strength

5%

Approval Date

2019-04-22

Regulatory Status

OTC

2024
26 Nov
OTC Application: 218175

Drug Name

MINOXIDIL (FOR WOMEN)

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2024-11-26

218175 / 1

Active Ingredient

MINOXIDIL

Application Number

218175

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2024-11-26

Regulatory Status

OTC

2025
30 Jun
OTC Application: 217998

Drug Name

MINOXIDIL EXTRA STRENGTH (FOR MEN)

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2025-06-30

217998 / 1

Active Ingredient

MINOXIDIL

Application Number

217998

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2025-06-30

Regulatory Status

OTC

2000
08 May
RX Application: 75520

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2000-05-08

75520 / 1

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

75520

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2000-05-08

Regulatory Status

RX

2000
08 May
RX Application: 75520

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2000-05-08

75520 / 2

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

75520

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2000-05-08

Regulatory Status

RX

2000
08 May
RX Application: 75520

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2000-05-08

75520 / 3

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

75520

Product Number

3

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2000-05-08

Regulatory Status

RX

2000
08 May
RX Application: 75520

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2000-05-08

75520 / 4

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

75520

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2000-05-08

Regulatory Status

RX

2006
20 Jun
Discontinued Application: 77965

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/5ML

Approval Date

2006-06-20

77965 / 1

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

77965

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/5ML

Approval Date

2006-06-20

Regulatory Status

Discontinued

1988
29 Feb
Discontinued Application: 62876

Drug Name

NYSTATIN

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/ML

Approval Date

1988-02-29

62876 / 1

Active Ingredient

NYSTATIN

Application Number

62876

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/ML

Approval Date

1988-02-29

Regulatory Status

Discontinued

2007
30 Nov
Discontinued Application: 77009

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML

Approval Date

2007-11-30

77009 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77009

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML

Approval Date

2007-11-30

Regulatory Status

Discontinued

2011
28 Mar
Discontinued Application: 77729

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2011-03-28

77729 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77729

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2011-03-28

Regulatory Status

Discontinued

2011
28 Mar
Discontinued Application: 77729

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2011-03-28

77729 / 2

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77729

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2011-03-28

Regulatory Status

Discontinued

2011
28 Mar
Discontinued Application: 77729

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 24MG BASE

Approval Date

2011-03-28

77729 / 3

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77729

Product Number

3

Dosage Form

-

Strength

EQ 24MG BASE

Approval Date

2011-03-28

Regulatory Status

Discontinued

1982
02 Aug
Discontinued Application: 18613

Drug Name

OVIDE

Product Number

1

Dosage Form

-

Strength

0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-08-02

18613 / 1

Active Ingredient

MALATHION

Application Number

18613

Product Number

1

Dosage Form

-

Strength

0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-08-02

Regulatory Status

Discontinued

2007
15 Nov
RX Application: 77801

Drug Name

OXCARBAZEPINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2007-11-15

77801 / 1

Active Ingredient

OXCARBAZEPINE

Application Number

77801

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2007-11-15

Regulatory Status

RX

2007
15 Nov
RX Application: 77801

Drug Name

OXCARBAZEPINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2007-11-15

77801 / 2

Active Ingredient

OXCARBAZEPINE

Application Number

77801

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2007-11-15

Regulatory Status

RX

2007
15 Nov
RX Application: 77801

Drug Name

OXCARBAZEPINE

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2007-11-15

77801 / 3

Active Ingredient

OXCARBAZEPINE

Application Number

77801

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2007-11-15

Regulatory Status

RX

2024
28 Jun
Discontinued Application: 207498

Drug Name

PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID

Product Number

1

Dosage Form

-

Strength

4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM

Approval Date

2024-06-28

207498 / 1

Active Ingredient

ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE

Application Number

207498

Product Number

1

Dosage Form

-

Strength

4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM

Approval Date

2024-06-28

Regulatory Status

Discontinued

2025
25 Nov
RX Application: 209538

Drug Name

PERAMPANEL

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2025-11-25

209538 / 1

Active Ingredient

PERAMPANEL

Application Number

209538

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2025-11-25

Regulatory Status

RX

2025
25 Nov
RX Application: 209538

Drug Name

PERAMPANEL

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2025-11-25

209538 / 2

Active Ingredient

PERAMPANEL

Application Number

209538

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2025-11-25

Regulatory Status

RX

2025
25 Nov
RX Application: 209538

Drug Name

PERAMPANEL

Product Number

3

Dosage Form

-

Strength

6MG

Approval Date

2025-11-25

209538 / 3

Active Ingredient

PERAMPANEL

Application Number

209538

Product Number

3

Dosage Form

-

Strength

6MG

Approval Date

2025-11-25

Regulatory Status

RX

2025
25 Nov
RX Application: 209538

Drug Name

PERAMPANEL

Product Number

4

Dosage Form

-

Strength

8MG

Approval Date

2025-11-25

209538 / 4

Active Ingredient

PERAMPANEL

Application Number

209538

Product Number

4

Dosage Form

-

Strength

8MG

Approval Date

2025-11-25

Regulatory Status

RX

2025
25 Nov
RX Application: 209538

Drug Name

PERAMPANEL

Product Number

5

Dosage Form

-

Strength

10MG

Approval Date

2025-11-25

209538 / 5

Active Ingredient

PERAMPANEL

Application Number

209538

Product Number

5

Dosage Form

-

Strength

10MG

Approval Date

2025-11-25

Regulatory Status

RX

2025
25 Nov
RX Application: 209538

Drug Name

PERAMPANEL

Product Number

6

Dosage Form

-

Strength

12MG

Approval Date

2025-11-25

209538 / 6

Active Ingredient

PERAMPANEL

Application Number

209538

Product Number

6

Dosage Form

-

Strength

12MG

Approval Date

2025-11-25

Regulatory Status

RX

2026
15 Jun
RX Application: 219052

Drug Name

PERAMPANEL

Product Number

1

Dosage Form

-

Strength

0.5MG/ML

Approval Date

2026-06-15

219052 / 1

Active Ingredient

PERAMPANEL

Application Number

219052

Product Number

1

Dosage Form

-

Strength

0.5MG/ML

Approval Date

2026-06-15

Regulatory Status

RX

2004
08 Mar
RX Application: 40521

Drug Name

PHENYTOIN

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

2004-03-08

40521 / 1

Active Ingredient

PHENYTOIN

Application Number

40521

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

2004-03-08

Regulatory Status

RX

2014
17 Apr
RX Application: 200565

Drug Name

PHENYTOIN

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2014-04-17

200565 / 1

Active Ingredient

PHENYTOIN

Application Number

200565

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2014-04-17

Regulatory Status

RX

2025
22 Jul
RX Application: 218960

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MEQ/15ML

Approval Date

2025-07-22

218960 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

218960

Product Number

1

Dosage Form

-

Strength

20MEQ/15ML

Approval Date

2025-07-22

Regulatory Status

RX

2025
03 Mar
RX Application: 208557

Drug Name

RIVAROXABAN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2025-03-03

208557 / 1

Active Ingredient

RIVAROXABAN

Application Number

208557

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2025-03-03

Regulatory Status

RX

2025
07 Oct
RX Application: 208557

Drug Name

RIVAROXABAN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2025-10-07

208557 / 2

Active Ingredient

RIVAROXABAN

Application Number

208557

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2025-10-07

Regulatory Status

RX

2025
07 Oct
RX Application: 208557

Drug Name

RIVAROXABAN

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2025-10-07

208557 / 3

Active Ingredient

RIVAROXABAN

Application Number

208557

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2025-10-07

Regulatory Status

RX

2025
07 Oct
RX Application: 208557

Drug Name

RIVAROXABAN

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2025-10-07

208557 / 4

Active Ingredient

RIVAROXABAN

Application Number

208557

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2025-10-07

Regulatory Status

RX

2021
16 Nov
Discontinued Application: 215522

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2021-11-16

215522 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

215522

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2021-11-16

Regulatory Status

Discontinued

2006
11 Aug
RX Application: 77407

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

45MG/5ML (9MG/ML)

Approval Date

2006-08-11

77407 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

77407

Product Number

1

Dosage Form

-

Strength

45MG/5ML (9MG/ML)

Approval Date

2006-08-11

Regulatory Status

RX

2006
11 Aug
RX Application: 77407

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

2006-08-11

77407 / 2

Active Ingredient

SODIUM CHLORIDE

Application Number

77407

Product Number

2

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

2006-08-11

Regulatory Status

RX

2024
19 Mar
RX Application: 206431

Drug Name

SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE

Product Number

1

Dosage Form

-

Strength

1.6GM/BOT;3.13GM/BOT;17.5GM/BOT

Approval Date

2024-03-19

206431 / 1

Active Ingredient

MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

Application Number

206431

Product Number

1

Dosage Form

-

Strength

1.6GM/BOT;3.13GM/BOT;17.5GM/BOT

Approval Date

2024-03-19

Regulatory Status

RX

-
Unclassified Application: 77393

Drug Name

STERILE WATER

Product Number

2

Dosage Form

-

Strength

10ML

Approval Date

-

77393 / 2

Active Ingredient

STERILE WATER

Application Number

77393

Product Number

2

Dosage Form

-

Strength

10ML

Approval Date

-

Regulatory Status

Unclassified

2006
11 Aug
Discontinued Application: 77393

Drug Name

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

2006-08-11

77393 / 1

Active Ingredient

STERILE WATER FOR INJECTION

Application Number

77393

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

2006-08-11

Regulatory Status

Discontinued

2003
26 Sep
Discontinued Application: 76525

Drug Name

TERIL

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2003-09-26

76525 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

76525

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2003-09-26

Regulatory Status

Discontinued

2004
20 Sep
RX Application: 76729

Drug Name

TERIL

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2004-09-20

76729 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

76729

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2004-09-20

Regulatory Status

RX

2025
28 Oct
RX Application: 211498

Drug Name

TICAGRELOR

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2025-10-28

211498 / 1

Active Ingredient

TICAGRELOR

Application Number

211498

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2025-10-28

Regulatory Status

RX

2025
28 Oct
RX Application: 211498

Drug Name

TICAGRELOR

Product Number

2

Dosage Form

-

Strength

90MG

Approval Date

2025-10-28

211498 / 2

Active Ingredient

TICAGRELOR

Application Number

211498

Product Number

2

Dosage Form

-

Strength

90MG

Approval Date

2025-10-28

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 17856

Drug Name

TOPICORT

Product Number

1

Dosage Form

-

Strength

0.25% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17856 / 1

Active Ingredient

DESOXIMETASONE

Application Number

17856

Product Number

1

Dosage Form

-

Strength

0.25% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
29 Mar
Discontinued Application: 18586

Drug Name

TOPICORT

Product Number

1

Dosage Form

-

Strength

0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-03-29

18586 / 1

Active Ingredient

DESOXIMETASONE

Application Number

18586

Product Number

1

Dosage Form

-

Strength

0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-03-29

Regulatory Status

Discontinued

1985
17 Jan
RX Application: 18594

Drug Name

TOPICORT

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1985-01-17

18594 / 1

Active Ingredient

DESOXIMETASONE

Application Number

18594

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1985-01-17

Regulatory Status

RX

1983
30 Sep
Discontinued Application: 18763

Drug Name

TOPICORT

Product Number

1

Dosage Form

-

Strength

0.25% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1983-09-30

18763 / 1

Active Ingredient

DESOXIMETASONE

Application Number

18763

Product Number

1

Dosage Form

-

Strength

0.25% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1983-09-30

Regulatory Status

Discontinued

1990
30 Nov
RX Application: 73193

Drug Name

TOPICORT

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1990-11-30

73193 / 1

Active Ingredient

DESOXIMETASONE

Application Number

73193

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1990-11-30

Regulatory Status

RX

1990
30 Nov
RX Application: 73210

Drug Name

TOPICORT

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1990-11-30

73210 / 1

Active Ingredient

DESOXIMETASONE

Application Number

73210

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1990-11-30

Regulatory Status

RX

1996
07 Jun
Discontinued Application: 74286

Drug Name

TOPICORT

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1996-06-07

74286 / 1

Active Ingredient

DESOXIMETASONE

Application Number

74286

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1996-06-07

Regulatory Status

Discontinued

1998
14 Jul
RX Application: 74904

Drug Name

TOPICORT

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1998-07-14

74904 / 1

Active Ingredient

DESOXIMETASONE

Application Number

74904

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1998-07-14

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 18309

Drug Name

TOPICORT LP

Product Number

1

Dosage Form

-

Strength

0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

18309 / 1

Active Ingredient

DESOXIMETASONE

Application Number

18309

Product Number

1

Dosage Form

-

Strength

0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1997
26 Nov
RX Application: 40039

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1997-11-26

40039 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

40039

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1997-11-26

Regulatory Status

RX

1999
15 Jul
RX Application: 40301

Drug Name

WARFARIN SODIUM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1999-07-15

40301 / 1

Active Ingredient

WARFARIN SODIUM

Application Number

40301

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1999-07-15

Regulatory Status

RX

1999
15 Jul
RX Application: 40301

Drug Name

WARFARIN SODIUM

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

1999-07-15

40301 / 2

Active Ingredient

WARFARIN SODIUM

Application Number

40301

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

1999-07-15

Regulatory Status

RX

1999
15 Jul
RX Application: 40301

Drug Name

WARFARIN SODIUM

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

1999-07-15

40301 / 3

Active Ingredient

WARFARIN SODIUM

Application Number

40301

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

1999-07-15

Regulatory Status

RX

1999
15 Jul
RX Application: 40301

Drug Name

WARFARIN SODIUM

Product Number

4

Dosage Form

-

Strength

2.5MG

Approval Date

1999-07-15

40301 / 4

Active Ingredient

WARFARIN SODIUM

Application Number

40301

Product Number

4

Dosage Form

-

Strength

2.5MG

Approval Date

1999-07-15

Regulatory Status

RX

1999
15 Jul
RX Application: 40301

Drug Name

WARFARIN SODIUM

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

1999-07-15

40301 / 5

Active Ingredient

WARFARIN SODIUM

Application Number

40301

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

1999-07-15

Regulatory Status

RX

1999
15 Jul
RX Application: 40301

Drug Name

WARFARIN SODIUM

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

1999-07-15

40301 / 6

Active Ingredient

WARFARIN SODIUM

Application Number

40301

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

1999-07-15

Regulatory Status

RX

1999
15 Jul
RX Application: 40301

Drug Name

WARFARIN SODIUM

Product Number

7

Dosage Form

-

Strength

5MG

Approval Date

1999-07-15

40301 / 7

Active Ingredient

WARFARIN SODIUM

Application Number

40301

Product Number

7

Dosage Form

-

Strength

5MG

Approval Date

1999-07-15

Regulatory Status

RX

1999
15 Jul
RX Application: 40301

Drug Name

WARFARIN SODIUM

Product Number

8

Dosage Form

-

Strength

6MG

Approval Date

1999-07-15

40301 / 8

Active Ingredient

WARFARIN SODIUM

Application Number

40301

Product Number

8

Dosage Form

-

Strength

6MG

Approval Date

1999-07-15

Regulatory Status

RX

1999
15 Jul
RX Application: 40301

Drug Name

WARFARIN SODIUM

Product Number

9

Dosage Form

-

Strength

7.5MG

Approval Date

1999-07-15

40301 / 9

Active Ingredient

WARFARIN SODIUM

Application Number

40301

Product Number

9

Dosage Form

-

Strength

7.5MG

Approval Date

1999-07-15

Regulatory Status

RX

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

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

A/T/S

Application Number

62405

Product Number

1

Active Ingredient

ERYTHROMYCIN

Dosage Form

-

Strength

2%

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

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