Wockhardt
FDA Approved Drugs

Wockhardt

FDA Approved Drugs Database

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

RX Unclassified Discontinued OTC
  • Total Records 120
  • Latest Approval Date May 29, 2026
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
120
View
Unclassified
5
View
Discontinued
83
View
OTC
1
View
RX
31
View
Company Overview

Company

Wockhardt

Country

India

Website

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Company Snapshot

Wockhardt

Wockhardt Towers, Bandra Mumbai 400051 Maharashtra

India

www.wockhardt.com/ View on Map
FDA Approved Drug Records ( 120 records )
2019
27 Feb
RX Application: 208380

Drug Name

ABIRATERONE ACETATE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2019-02-27

208380 / 1

Active Ingredient

ABIRATERONE ACETATE

Application Number

208380

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2019-02-27

Regulatory Status

RX

-
Unclassified Application: 79147

Drug Name

ADENOSINE

Product Number

1

Dosage Form

-

Strength

3MG/ML

Approval Date

-

79147 / 1

Active Ingredient

ADENOSINE

Application Number

79147

Product Number

1

Dosage Form

-

Strength

3MG/ML

Approval Date

-

Regulatory Status

Unclassified

2009
20 Jul
Discontinued Application: 90220

Drug Name

ADENOSINE

Product Number

1

Dosage Form

-

Strength

3MG/ML

Approval Date

2009-07-20

90220 / 1

Active Ingredient

ADENOSINE

Application Number

90220

Product Number

1

Dosage Form

-

Strength

3MG/ML

Approval Date

2009-07-20

Regulatory Status

Discontinued

1999
22 Nov
Discontinued Application: 75394

Drug Name

ALBUTEROL SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 0.083% BASE

Approval Date

1999-11-22

75394 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

75394

Product Number

1

Dosage Form

-

Strength

EQ 0.083% BASE

Approval Date

1999-11-22

Regulatory Status

Discontinued

2012
10 Aug
Discontinued Application: 90221

Drug Name

ALFUZOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2012-08-10

90221 / 1

Active Ingredient

ALFUZOSIN HYDROCHLORIDE

Application Number

90221

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2012-08-10

Regulatory Status

Discontinued

2007
06 Sep
Discontinued Application: 78500

Drug Name

AMLODIPINE BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-09-06

78500 / 1

Active Ingredient

AMLODIPINE BESYLATE

Application Number

78500

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-09-06

Regulatory Status

Discontinued

2007
06 Sep
Discontinued Application: 78500

Drug Name

AMLODIPINE BESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-09-06

78500 / 2

Active Ingredient

AMLODIPINE BESYLATE

Application Number

78500

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-09-06

Regulatory Status

Discontinued

2007
06 Sep
Discontinued Application: 78500

Drug Name

AMLODIPINE BESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-09-06

78500 / 3

Active Ingredient

AMLODIPINE BESYLATE

Application Number

78500

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-09-06

Regulatory Status

Discontinued

2003
29 Sep
Discontinued Application: 40518

Drug Name

BETHANECHOL CHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-09-29

40518 / 1

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

40518

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-09-29

Regulatory Status

Discontinued

2003
29 Sep
Discontinued Application: 40532

Drug Name

BETHANECHOL CHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2003-09-29

40532 / 1

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

40532

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2003-09-29

Regulatory Status

Discontinued

2003
29 Sep
Discontinued Application: 40533

Drug Name

BETHANECHOL CHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2003-09-29

40533 / 1

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

40533

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2003-09-29

Regulatory Status

Discontinued

2003
29 Sep
Discontinued Application: 40534

Drug Name

BETHANECHOL CHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2003-09-29

40534 / 1

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

40534

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2003-09-29

Regulatory Status

Discontinued

1988
22 Dec
Discontinued Application: 89681

Drug Name

BROMFED-DM

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1988-12-22

89681 / 1

Active Ingredient

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

89681

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1988-12-22

Regulatory Status

Discontinued

1984
12 Oct
Discontinued Application: 88626

Drug Name

BROMODIPHENHYDRAMINE HYDROCHLORIDE AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

12.5MG/5ML;10MG/5ML

Approval Date

1984-10-12

88626 / 1

Active Ingredient

BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE

Application Number

88626

Product Number

1

Dosage Form

-

Strength

12.5MG/5ML;10MG/5ML

Approval Date

1984-10-12

Regulatory Status

Discontinued

2012
30 Aug
Discontinued Application: 201331

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2012-08-30

201331 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

201331

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2012-08-30

Regulatory Status

Discontinued

2012
30 Aug
Discontinued Application: 201331

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2012-08-30

201331 / 2

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

201331

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2012-08-30

Regulatory Status

Discontinued

2012
30 Aug
Discontinued Application: 201331

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2012-08-30

201331 / 3

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

201331

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2012-08-30

Regulatory Status

Discontinued

2012
21 Nov
RX Application: 202189

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2012-11-21

202189 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

202189

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2012-11-21

Regulatory Status

RX

2022
28 Jan
RX Application: 202189

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2022-01-28

202189 / 2

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

202189

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2022-01-28

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 85383

Drug Name

BUTABARBITAL SODIUM

Product Number

1

Dosage Form

-

Strength

30MG/5ML

Approval Date

1982-01-01

85383 / 1

Active Ingredient

BUTABARBITAL SODIUM

Application Number

85383

Product Number

1

Dosage Form

-

Strength

30MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1997
28 Mar
RX Application: 74532

Drug Name

CAPTOPRIL

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1997-03-28

74532 / 1

Active Ingredient

CAPTOPRIL

Application Number

74532

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1997-03-28

Regulatory Status

RX

1997
28 Mar
RX Application: 74532

Drug Name

CAPTOPRIL

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1997-03-28

74532 / 2

Active Ingredient

CAPTOPRIL

Application Number

74532

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1997-03-28

Regulatory Status

RX

1997
28 Mar
RX Application: 74532

Drug Name

CAPTOPRIL

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1997-03-28

74532 / 3

Active Ingredient

CAPTOPRIL

Application Number

74532

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1997-03-28

Regulatory Status

RX

1997
28 Mar
RX Application: 74532

Drug Name

CAPTOPRIL

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1997-03-28

74532 / 4

Active Ingredient

CAPTOPRIL

Application Number

74532

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1997-03-28

Regulatory Status

RX

2012
20 Nov
Discontinued Application: 90786

Drug Name

CARBIDOPA, LEVODOPA AND ENTACAPONE

Product Number

1

Dosage Form

-

Strength

12.5MG;200MG;50MG

Approval Date

2012-11-20

90786 / 1

Active Ingredient

CARBIDOPA; ENTACAPONE; LEVODOPA

Application Number

90786

Product Number

1

Dosage Form

-

Strength

12.5MG;200MG;50MG

Approval Date

2012-11-20

Regulatory Status

Discontinued

2012
20 Nov
Discontinued Application: 90833

Drug Name

CARBIDOPA, LEVODOPA AND ENTACAPONE

Product Number

1

Dosage Form

-

Strength

18.75MG;200MG;75MG

Approval Date

2012-11-20

90833 / 1

Active Ingredient

CARBIDOPA; ENTACAPONE; LEVODOPA

Application Number

90833

Product Number

1

Dosage Form

-

Strength

18.75MG;200MG;75MG

Approval Date

2012-11-20

Regulatory Status

Discontinued

2012
20 Nov
Discontinued Application: 90833

Drug Name

CARBIDOPA, LEVODOPA AND ENTACAPONE

Product Number

2

Dosage Form

-

Strength

25MG;200MG;100MG

Approval Date

2012-11-20

90833 / 2

Active Ingredient

CARBIDOPA; ENTACAPONE; LEVODOPA

Application Number

90833

Product Number

2

Dosage Form

-

Strength

25MG;200MG;100MG

Approval Date

2012-11-20

Regulatory Status

Discontinued

2012
20 Nov
Discontinued Application: 90833

Drug Name

CARBIDOPA, LEVODOPA AND ENTACAPONE

Product Number

3

Dosage Form

-

Strength

31.25MG;200MG;125MG

Approval Date

2012-11-20

90833 / 3

Active Ingredient

CARBIDOPA; ENTACAPONE; LEVODOPA

Application Number

90833

Product Number

3

Dosage Form

-

Strength

31.25MG;200MG;125MG

Approval Date

2012-11-20

Regulatory Status

Discontinued

2012
20 Nov
Discontinued Application: 90833

Drug Name

CARBIDOPA, LEVODOPA AND ENTACAPONE

Product Number

4

Dosage Form

-

Strength

37.5MG;200MG;150MG

Approval Date

2012-11-20

90833 / 4

Active Ingredient

CARBIDOPA; ENTACAPONE; LEVODOPA

Application Number

90833

Product Number

4

Dosage Form

-

Strength

37.5MG;200MG;150MG

Approval Date

2012-11-20

Regulatory Status

Discontinued

2012
20 Nov
Discontinued Application: 90833

Drug Name

CARBIDOPA, LEVODOPA AND ENTACAPONE

Product Number

5

Dosage Form

-

Strength

50MG;200MG;200MG

Approval Date

2012-11-20

90833 / 5

Active Ingredient

CARBIDOPA; ENTACAPONE; LEVODOPA

Application Number

90833

Product Number

5

Dosage Form

-

Strength

50MG;200MG;200MG

Approval Date

2012-11-20

Regulatory Status

Discontinued

2006
29 Aug
Discontinued Application: 65197

Drug Name

CEFOTAXIME

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2006-08-29

65197 / 1

Active Ingredient

CEFOTAXIME SODIUM

Application Number

65197

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2006-08-29

Regulatory Status

Discontinued

2008
20 Jun
Discontinued Application: 65197

Drug Name

CEFOTAXIME SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2008-06-20

65197 / 2

Active Ingredient

CEFOTAXIME SODIUM

Application Number

65197

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2008-06-20

Regulatory Status

Discontinued

2008
20 Jun
Discontinued Application: 65197

Drug Name

CEFOTAXIME SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2008-06-20

65197 / 3

Active Ingredient

CEFOTAXIME SODIUM

Application Number

65197

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2008-06-20

Regulatory Status

Discontinued

2007
14 Jun
Discontinued Application: 65428

Drug Name

CEFPROZIL

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2007-06-14

65428 / 1

Active Ingredient

CEFPROZIL

Application Number

65428

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2007-06-14

Regulatory Status

Discontinued

2007
14 Jun
Discontinued Application: 65428

Drug Name

CEFPROZIL

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2007-06-14

65428 / 2

Active Ingredient

CEFPROZIL

Application Number

65428

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2007-06-14

Regulatory Status

Discontinued

2008
15 Oct
Discontinued Application: 65196

Drug Name

CEFTAZIDIME

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2008-10-15

65196 / 1

Active Ingredient

CEFTAZIDIME

Application Number

65196

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2008-10-15

Regulatory Status

Discontinued

2007
12 Apr
RX Application: 65391

Drug Name

CEFTRIAXONE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2007-04-12

65391 / 1

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65391

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2007-04-12

Regulatory Status

RX

2007
12 Apr
RX Application: 65391

Drug Name

CEFTRIAXONE

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2007-04-12

65391 / 2

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65391

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2007-04-12

Regulatory Status

RX

2007
12 Apr
RX Application: 65391

Drug Name

CEFTRIAXONE

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2007-04-12

65391 / 3

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65391

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2007-04-12

Regulatory Status

RX

1982
08 Jul
Discontinued Application: 87032

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

1982-07-08

87032 / 1

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

87032

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

1982-07-08

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87053

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1982-01-01

87053 / 1

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

87053

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2006
31 May
Discontinued Application: 65266

Drug Name

CLARITHROMYCIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2006-05-31

65266 / 1

Active Ingredient

CLARITHROMYCIN

Application Number

65266

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2006-05-31

Regulatory Status

Discontinued

2006
31 May
Discontinued Application: 65266

Drug Name

CLARITHROMYCIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2006-05-31

65266 / 2

Active Ingredient

CLARITHROMYCIN

Application Number

65266

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2006-05-31

Regulatory Status

Discontinued

1998
13 Mar
Discontinued Application: 74863

Drug Name

CLEMASTINE FUMARATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE/5ML

Approval Date

1998-03-13

74863 / 1

Active Ingredient

CLEMASTINE FUMARATE

Application Number

74863

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE/5ML

Approval Date

1998-03-13

Regulatory Status

Discontinued

1998
13 Nov
Discontinued Application: 75205

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1998-11-13

75205 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

75205

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1998-11-13

Regulatory Status

Discontinued

1999
25 Oct
RX Application: 75346

Drug Name

CROMOLYN SODIUM

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1999-10-25

75346 / 1

Active Ingredient

CROMOLYN SODIUM

Application Number

75346

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1999-10-25

Regulatory Status

RX

2019
09 Apr
RX Application: 209056

Drug Name

DECITABINE

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2019-04-09

209056 / 1

Active Ingredient

DECITABINE

Application Number

209056

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2019-04-09

Regulatory Status

RX

2011
31 May
Discontinued Application: 91267

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-05-31

91267 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

91267

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-05-31

Regulatory Status

Discontinued

2011
31 May
Discontinued Application: 91267

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-05-31

91267 / 2

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

91267

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-05-31

Regulatory Status

Discontinued

-
Unclassified Application: 90773

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

-

90773 / 1

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

90773

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 90773

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

-

90773 / 2

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

90773

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 90773

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

-

90773 / 3

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

90773

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

-

Regulatory Status

Unclassified

2012
16 Aug
RX Application: 78941

Drug Name

ENTACAPONE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2012-08-16

78941 / 1

Active Ingredient

ENTACAPONE

Application Number

78941

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2012-08-16

Regulatory Status

RX

2008
30 Jan
Discontinued Application: 40732

Drug Name

EXTENDED PHENYTOIN SODIUM

Product Number

1

Dosage Form

-

Strength

100MG EXTENDED

Approval Date

2008-01-30

40732 / 1

Active Ingredient

PHENYTOIN SODIUM

Application Number

40732

Product Number

1

Dosage Form

-

Strength

100MG EXTENDED

Approval Date

2008-01-30

Regulatory Status

Discontinued

2007
18 Dec
Discontinued Application: 40759

Drug Name

EXTENDED PHENYTOIN SODIUM

Product Number

1

Dosage Form

-

Strength

30MG EXTENDED

Approval Date

2007-12-18

40759 / 1

Active Ingredient

PHENYTOIN SODIUM

Application Number

40759

Product Number

1

Dosage Form

-

Strength

30MG EXTENDED

Approval Date

2007-12-18

Regulatory Status

Discontinued

2012
15 Aug
Discontinued Application: 91484

Drug Name

FELODIPINE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2012-08-15

91484 / 1

Active Ingredient

FELODIPINE

Application Number

91484

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2012-08-15

Regulatory Status

Discontinued

2012
15 Aug
Discontinued Application: 91484

Drug Name

FELODIPINE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2012-08-15

91484 / 2

Active Ingredient

FELODIPINE

Application Number

91484

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2012-08-15

Regulatory Status

Discontinued

2012
15 Aug
Discontinued Application: 91484

Drug Name

FELODIPINE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2012-08-15

91484 / 3

Active Ingredient

FELODIPINE

Application Number

91484

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2012-08-15

Regulatory Status

Discontinued

-
Unclassified Application: 79115

Drug Name

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG; 120MG

Approval Date

-

79115 / 1

Active Ingredient

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

79115

Product Number

1

Dosage Form

-

Strength

60MG; 120MG

Approval Date

-

Regulatory Status

Unclassified

2007
06 Aug
RX Application: 78137

Drug Name

FOSPHENYTOIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 50MG PHENYTOIN NA/ML

Approval Date

2007-08-06

78137 / 1

Active Ingredient

FOSPHENYTOIN SODIUM

Application Number

78137

Product Number

1

Dosage Form

-

Strength

EQ 50MG PHENYTOIN NA/ML

Approval Date

2007-08-06

Regulatory Status

RX

2008
30 Jun
Discontinued Application: 78564

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2008-06-30

78564 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

78564

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2008-06-30

Regulatory Status

Discontinued

2008
30 Jun
Discontinued Application: 78565

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

Approval Date

2008-06-30

78565 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

78565

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

Approval Date

2008-06-30

Regulatory Status

Discontinued

2008
29 Feb
Discontinued Application: 78566

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

Approval Date

2008-02-29

78566 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

78566

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

Approval Date

2008-02-29

Regulatory Status

Discontinued

1996
30 Aug
Discontinued Application: 40168

Drug Name

HYDROCORTISONE AND ACETIC ACID

Product Number

1

Dosage Form

-

Strength

2%;1%

Approval Date

1996-08-30

40168 / 1

Active Ingredient

ACETIC ACID, GLACIAL; HYDROCORTISONE

Application Number

40168

Product Number

1

Dosage Form

-

Strength

2%;1%

Approval Date

1996-08-30

Regulatory Status

Discontinued

2007
27 Mar
Discontinued Application: 77943

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

2007-03-27

77943 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

77943

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

2007-03-27

Regulatory Status

Discontinued

1984
16 Aug
Discontinued Application: 88190

Drug Name

LINDANE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1984-08-16

88190 / 1

Active Ingredient

LINDANE

Application Number

88190

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1984-08-16

Regulatory Status

Discontinued

1984
18 Sep
Discontinued Application: 88191

Drug Name

LINDANE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1984-09-18

88191 / 1

Active Ingredient

LINDANE

Application Number

88191

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1984-09-18

Regulatory Status

Discontinued

2007
19 Apr
RX Application: 78402

Drug Name

LISINOPRIL

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2007-04-19

78402 / 1

Active Ingredient

LISINOPRIL

Application Number

78402

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2007-04-19

Regulatory Status

RX

2007
19 Apr
RX Application: 78402

Drug Name

LISINOPRIL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2007-04-19

78402 / 2

Active Ingredient

LISINOPRIL

Application Number

78402

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2007-04-19

Regulatory Status

RX

2007
19 Apr
RX Application: 78402

Drug Name

LISINOPRIL

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2007-04-19

78402 / 3

Active Ingredient

LISINOPRIL

Application Number

78402

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2007-04-19

Regulatory Status

RX

2007
19 Apr
RX Application: 78402

Drug Name

LISINOPRIL

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2007-04-19

78402 / 4

Active Ingredient

LISINOPRIL

Application Number

78402

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2007-04-19

Regulatory Status

RX

2007
19 Apr
RX Application: 78402

Drug Name

LISINOPRIL

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2007-04-19

78402 / 5

Active Ingredient

LISINOPRIL

Application Number

78402

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2007-04-19

Regulatory Status

RX

2007
19 Apr
RX Application: 78402

Drug Name

LISINOPRIL

Product Number

6

Dosage Form

-

Strength

40MG

Approval Date

2007-04-19

78402 / 6

Active Ingredient

LISINOPRIL

Application Number

78402

Product Number

6

Dosage Form

-

Strength

40MG

Approval Date

2007-04-19

Regulatory Status

RX

1997
28 Aug
Discontinued Application: 74730

Drug Name

LOPERAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG/5ML

Approval Date

1997-08-28

74730 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE

Application Number

74730

Product Number

1

Dosage Form

-

Strength

1MG/5ML

Approval Date

1997-08-28

Regulatory Status

Discontinued

2004
20 Aug
OTC Application: 75815

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2004-08-20

75815 / 1

Active Ingredient

LORATADINE

Application Number

75815

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2004-08-20

Regulatory Status

OTC

1988
07 Jun
Discontinued Application: 72190

Drug Name

METAPROTERENOL SULFATE

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

1988-06-07

72190 / 1

Active Ingredient

METAPROTERENOL SULFATE

Application Number

72190

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

1988-06-07

Regulatory Status

Discontinued

1997
24 Mar
Discontinued Application: 74702

Drug Name

METAPROTERENOL SULFATE

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

1997-03-24

74702 / 1

Active Ingredient

METAPROTERENOL SULFATE

Application Number

74702

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

1997-03-24

Regulatory Status

Discontinued

2002
30 May
Discontinued Application: 75586

Drug Name

METAPROTERENOL SULFATE

Product Number

1

Dosage Form

-

Strength

0.4%

Approval Date

2002-05-30

75586 / 1

Active Ingredient

METAPROTERENOL SULFATE

Application Number

75586

Product Number

1

Dosage Form

-

Strength

0.4%

Approval Date

2002-05-30

Regulatory Status

Discontinued

2002
30 May
Discontinued Application: 75586

Drug Name

METAPROTERENOL SULFATE

Product Number

2

Dosage Form

-

Strength

0.6%

Approval Date

2002-05-30

75586 / 2

Active Ingredient

METAPROTERENOL SULFATE

Application Number

75586

Product Number

2

Dosage Form

-

Strength

0.6%

Approval Date

2002-05-30

Regulatory Status

Discontinued

2010
22 Jul
RX Application: 90615

Drug Name

METOPROLOL SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG TARTRATE

Approval Date

2010-07-22

90615 / 1

Active Ingredient

METOPROLOL SUCCINATE

Application Number

90615

Product Number

1

Dosage Form

-

Strength

EQ 25MG TARTRATE

Approval Date

2010-07-22

Regulatory Status

RX

2010
22 Jul
RX Application: 90615

Drug Name

METOPROLOL SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG TARTRATE

Approval Date

2010-07-22

90615 / 2

Active Ingredient

METOPROLOL SUCCINATE

Application Number

90615

Product Number

2

Dosage Form

-

Strength

EQ 50MG TARTRATE

Approval Date

2010-07-22

Regulatory Status

RX

2010
22 Jul
RX Application: 90615

Drug Name

METOPROLOL SUCCINATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

2010-07-22

90615 / 3

Active Ingredient

METOPROLOL SUCCINATE

Application Number

90615

Product Number

3

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

2010-07-22

Regulatory Status

RX

2010
22 Jul
RX Application: 90615

Drug Name

METOPROLOL SUCCINATE

Product Number

4

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

2010-07-22

90615 / 4

Active Ingredient

METOPROLOL SUCCINATE

Application Number

90615

Product Number

4

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

2010-07-22

Regulatory Status

RX

1992
28 Apr
Discontinued Application: 81134

Drug Name

NIACIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1992-04-28

81134 / 1

Active Ingredient

NIACIN

Application Number

81134

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1992-04-28

Regulatory Status

Discontinued

2011
11 May
Discontinued Application: 90986

Drug Name

OCTREOTIDE ACETATE

Product Number

1

Dosage Form

-

Strength

EQ 0.2MG BASE/ML

Approval Date

2011-05-11

90986 / 1

Active Ingredient

OCTREOTIDE ACETATE

Application Number

90986

Product Number

1

Dosage Form

-

Strength

EQ 0.2MG BASE/ML

Approval Date

2011-05-11

Regulatory Status

Discontinued

2011
11 May
Discontinued Application: 90986

Drug Name

OCTREOTIDE ACETATE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2011-05-11

90986 / 2

Active Ingredient

OCTREOTIDE ACETATE

Application Number

90986

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2011-05-11

Regulatory Status

Discontinued

2011
11 May
Discontinued Application: 90985

Drug Name

OCTREOTIDE ACETATE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

2011-05-11

90985 / 1

Active Ingredient

OCTREOTIDE ACETATE

Application Number

90985

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

2011-05-11

Regulatory Status

Discontinued

2011
11 May
Discontinued Application: 90985

Drug Name

OCTREOTIDE ACETATE PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

EQ 0.1MG BASE/ML

Approval Date

2011-05-11

90985 / 2

Active Ingredient

OCTREOTIDE ACETATE

Application Number

90985

Product Number

2

Dosage Form

-

Strength

EQ 0.1MG BASE/ML

Approval Date

2011-05-11

Regulatory Status

Discontinued

2011
11 May
Discontinued Application: 90985

Drug Name

OCTREOTIDE ACETATE PRESERVATIVE FREE

Product Number

3

Dosage Form

-

Strength

EQ 0.5MG BASE/ML

Approval Date

2011-05-11

90985 / 3

Active Ingredient

OCTREOTIDE ACETATE

Application Number

90985

Product Number

3

Dosage Form

-

Strength

EQ 0.5MG BASE/ML

Approval Date

2011-05-11

Regulatory Status

Discontinued

2006
26 Dec
RX Application: 77577

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

77577 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77577

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

Regulatory Status

RX

2006
26 Dec
RX Application: 77716

Drug Name

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

77716 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77716

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

Regulatory Status

RX

2017
31 Jul
RX Application: 207147

Drug Name

OXACILLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2017-07-31

207147 / 1

Active Ingredient

OXACILLIN SODIUM

Application Number

207147

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2017-07-31

Regulatory Status

RX

2017
31 Jul
RX Application: 207147

Drug Name

OXACILLIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2017-07-31

207147 / 2

Active Ingredient

OXACILLIN SODIUM

Application Number

207147

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2017-07-31

Regulatory Status

RX

2017
24 Nov
RX Application: 207148

Drug Name

OXACILLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2017-11-24

207148 / 1

Active Ingredient

OXACILLIN SODIUM

Application Number

207148

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2017-11-24

Regulatory Status

RX

2008
26 Sep
Discontinued Application: 40785

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2008-09-26

40785 / 1

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40785

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2008-09-26

Regulatory Status

Discontinued

2008
26 Sep
Discontinued Application: 40785

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG/ML

Approval Date

2008-09-26

40785 / 2

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40785

Product Number

2

Dosage Form

-

Strength

50MG/ML

Approval Date

2008-09-26

Regulatory Status

Discontinued

1985
04 Jan
Discontinued Application: 88896

Drug Name

PROMETHAZINE VC W/ CODEINE

Product Number

1

Dosage Form

-

Strength

10MG/5ML;5MG/5ML;6.25MG/5ML

Approval Date

1985-01-04

88896 / 1

Active Ingredient

CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

Application Number

88896

Product Number

1

Dosage Form

-

Strength

10MG/5ML;5MG/5ML;6.25MG/5ML

Approval Date

1985-01-04

Regulatory Status

Discontinued

2007
16 Mar
Discontinued Application: 77677

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;50MG

Approval Date

2007-03-16

77677 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Application Number

77677

Product Number

1

Dosage Form

-

Strength

325MG;50MG

Approval Date

2007-03-16

Regulatory Status

Discontinued

2007
16 Mar
Discontinued Application: 77677

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

650MG;100MG

Approval Date

2007-03-16

77677 / 2

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Application Number

77677

Product Number

2

Dosage Form

-

Strength

650MG;100MG

Approval Date

2007-03-16

Regulatory Status

Discontinued

1998
17 Dec
Discontinued Application: 75208

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1998-12-17

75208 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

75208

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1998-12-17

Regulatory Status

Discontinued

1998
17 Dec
Discontinued Application: 75208

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

1998-12-17

75208 / 2

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

75208

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

1998-12-17

Regulatory Status

Discontinued

2006
24 Feb
Discontinued Application: 76760

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2006-02-24

76760 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

76760

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2006-02-24

Regulatory Status

Discontinued

2007
26 Nov
Discontinued Application: 78653

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2007-11-26

78653 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

78653

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2007-11-26

Regulatory Status

Discontinued

2009
12 Nov
Discontinued Application: 78701

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2009-11-12

78701 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

78701

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2009-11-12

Regulatory Status

Discontinued

2009
11 Dec
Discontinued Application: 78701

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2009-12-11

78701 / 2

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

78701

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2009-12-11

Regulatory Status

Discontinued

2008
31 Jul
Discontinued Application: 78884

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2008-07-31

78884 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

78884

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2008-07-31

Regulatory Status

Discontinued

2009
26 May
Discontinued Application: 79211

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE/ML

Approval Date

2009-05-26

79211 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

79211

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE/ML

Approval Date

2009-05-26

Regulatory Status

Discontinued

2009
23 Feb
Discontinued Application: 79212

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE/ML

Approval Date

2009-02-23

79212 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

79212

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE/ML

Approval Date

2009-02-23

Regulatory Status

Discontinued

2009
08 Oct
Discontinued Application: 78744

Drug Name

RISPERIDONE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2009-10-08

78744 / 1

Active Ingredient

RISPERIDONE

Application Number

78744

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2009-10-08

Regulatory Status

Discontinued

2009
06 Feb
RX Application: 78593

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2009-02-06

78593 / 1

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

78593

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2009-02-06

Regulatory Status

RX

2007
02 Jul
Discontinued Application: 78229

Drug Name

TERBINAFINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2007-07-02

78229 / 1

Active Ingredient

TERBINAFINE HYDROCHLORIDE

Application Number

78229

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2007-07-02

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86748

Drug Name

THEOPHYLLINE

Product Number

1

Dosage Form

-

Strength

80MG/15ML

Approval Date

1982-01-01

86748 / 1

Active Ingredient

THEOPHYLLINE

Application Number

86748

Product Number

1

Dosage Form

-

Strength

80MG/15ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1983
05 Jul
Discontinued Application: 88227

Drug Name

THIORIDAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1983-07-05

88227 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

88227

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1983-07-05

Regulatory Status

Discontinued

1983
25 Jul
Discontinued Application: 88258

Drug Name

THIORIDAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

1983-07-25

88258 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

88258

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

1983-07-25

Regulatory Status

Discontinued

1999
25 Jan
Discontinued Application: 75260

Drug Name

TRETINOIN

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1999-01-25

75260 / 1

Active Ingredient

TRETINOIN

Application Number

75260

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1999-01-25

Regulatory Status

Discontinued

1983
26 Jul
Discontinued Application: 88143

Drug Name

TRIFLUOPERAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1983-07-26

88143 / 1

Active Ingredient

TRIFLUOPERAZINE HYDROCHLORIDE

Application Number

88143

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1983-07-26

Regulatory Status

Discontinued

1984
16 Nov
Discontinued Application: 88833

Drug Name

TRIPROLIDINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

10MG/5ML;30MG/5ML;1.25MG/5ML

Approval Date

1984-11-16

88833 / 1

Active Ingredient

CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

Application Number

88833

Product Number

1

Dosage Form

-

Strength

10MG/5ML;30MG/5ML;1.25MG/5ML

Approval Date

1984-11-16

Regulatory Status

Discontinued

2026
29 May
RX Application: 220787

Drug Name

ZAYNICH

Product Number

1

Dosage Form

-

Strength

EQ 2GM BASE/VIAL;1GM/VIAL

Approval Date

2026-05-29

220787 / 1

Active Ingredient

CEFEPIME HYDROCHLORIDE; ZIDEBACTAM

Application Number

220787

Product Number

1

Dosage Form

-

Strength

EQ 2GM BASE/VIAL;1GM/VIAL

Approval Date

2026-05-29

Regulatory Status

RX

2007
15 May
Discontinued Application: 78426

Drug Name

ZOLPIDEM TARTRATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-05-15

78426 / 1

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

78426

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-05-15

Regulatory Status

Discontinued

2007
15 May
Discontinued Application: 78426

Drug Name

ZOLPIDEM TARTRATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-05-15

78426 / 2

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

78426

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-05-15

Regulatory Status

Discontinued

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Drug Status Breakdown
120 total
  • RX
  • Unclassified
  • Discontinued
  • OTC
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

ABIRATERONE ACETATE

Application Number

208380

Product Number

1

Active Ingredient

ABIRATERONE ACETATE

Dosage Form

-

Strength

250MG

FDA Approved Drug Data

Approved drug product information

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