Bayer AG Discontinued

1982

01 Jan

Discontinued Application: 16030

Drug Name

8-HOUR BAYER

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

1982-01-01

16030 / 1 View Details

Active Ingredient

ASPIRIN

Application Number

16030

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1995

06 Oct

Discontinued Application: 20499

Drug Name

ACTRON

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1995-10-06

20499 / 1 View Details

Active Ingredient

KETOPROFEN

Application Number

20499

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1995-10-06

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12470

Drug Name

AKRINOL

Product Number

1

Dosage Form

-

Strength

2MG/GM

Approval Date

1982-01-01

12470 / 1 View Details

Active Ingredient

ACRISORCIN

Application Number

12470

Product Number

1

Dosage Form

-

Strength

2MG/GM

Approval Date

1982-01-01

Regulatory Status

Discontinued

1999

29 Nov

Discontinued Application: 21076

Drug Name

ALEVE-D SINUS & COLD

Product Number

1

Dosage Form

-

Strength

220MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-11-29

21076 / 1 View Details

Active Ingredient

NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

21076

Product Number

1

Dosage Form

-

Strength

220MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-11-29

Regulatory Status

Discontinued

2017

14 Sep

Discontinued Application: 209936

Drug Name

ALIQOPA

Product Number

1

Dosage Form

-

Strength

60MG/VIAL

Approval Date

2017-09-14

209936 / 1 View Details

Active Ingredient

COPANLISIB DIHYDROCHLORIDE

Application Number

209936

Product Number

1

Dosage Form

-

Strength

60MG/VIAL

Approval Date

2017-09-14

Regulatory Status

Discontinued

1982

23 Sep

Discontinued Application: 87726

Drug Name

ANGIOVIST 282

Product Number

1

Dosage Form

-

Strength

60%

Approval Date

1982-09-23

87726 / 1 View Details

Active Ingredient

DIATRIZOATE MEGLUMINE

Application Number

87726

Product Number

1

Dosage Form

-

Strength

60%

Approval Date

1982-09-23

Regulatory Status

Discontinued

1982

23 Sep

Discontinued Application: 87724

Drug Name

ANGIOVIST 292

Product Number

1

Dosage Form

-

Strength

52%;8%

Approval Date

1982-09-23

87724 / 1 View Details

Active Ingredient

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

Application Number

87724

Product Number

1

Dosage Form

-

Strength

52%;8%

Approval Date

1982-09-23

Regulatory Status

Discontinued

1982

23 Sep

Discontinued Application: 87723

Drug Name

ANGIOVIST 370

Product Number

1

Dosage Form

-

Strength

66%;10%

Approval Date

1982-09-23

87723 / 1 View Details

Active Ingredient

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

Application Number

87723

Product Number

1

Dosage Form

-

Strength

66%;10%

Approval Date

1982-09-23

Regulatory Status

Discontinued

1999

10 Dec

Discontinued Application: 21085

Drug Name

AVELOX

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-12-10

21085 / 1 View Details

Active Ingredient

MOXIFLOXACIN HYDROCHLORIDE

Application Number

21085

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-12-10

Regulatory Status

Discontinued

2001

30 Nov

Discontinued Application: 21277

Drug Name

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-11-30

21277 / 1 View Details

Active Ingredient

MOXIFLOXACIN HYDROCHLORIDE

Application Number

21277

Product Number

1

Dosage Form

-

Strength

400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-11-30

Regulatory Status

Discontinued

2001

18 Oct

Discontinued Application: 21317

Drug Name

BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2001-10-18

21317 / 1 View Details

Active Ingredient

ASPIRIN

Application Number

21317

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2001-10-18

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 16053

Drug Name

BETAPAR

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

16053 / 2 View Details

Active Ingredient

MEPREDNISONE

Application Number

16053

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

11 Aug

Discontinued Application: 87768

Drug Name

BILIVIST

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-08-11

87768 / 1 View Details

Active Ingredient

IPODATE SODIUM

Application Number

87768

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-08-11

Regulatory Status

Discontinued

1982

29 Dec

Discontinued Application: 18714

Drug Name

BILTRICIDE

Product Number

1

Dosage Form

-

Strength

600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-12-29

18714 / 1 View Details

Active Ingredient

PRAZIQUANTEL

Application Number

18714

Product Number

1

Dosage Form

-

Strength

600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-12-29

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12657

Drug Name

CELESTONE

Product Number

3

Dosage Form

-

Strength

0.6MG

Approval Date

1982-01-01

12657 / 3 View Details

Active Ingredient

BETAMETHASONE

Application Number

12657

Product Number

3

Dosage Form

-

Strength

0.6MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 14762

Drug Name

CELESTONE

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

1982-01-01

14762 / 1 View Details

Active Ingredient

BETAMETHASONE

Application Number

14762

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17561

Drug Name

CELESTONE

Product Number

1

Dosage Form

-

Strength

EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17561 / 1 View Details

Active Ingredient

BETAMETHASONE SODIUM PHOSPHATE

Application Number

17561

Product Number

1

Dosage Form

-

Strength

EQ 3MG BASE/ML **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

Discontinued Application: 6921

Drug Name

CHLOR-TRIMETON

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

6921 / 2 View Details

Active Ingredient

CHLORPHENIRAMINE MALEATE

Application Number

6921

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 6921

Drug Name

CHLOR-TRIMETON

Product Number

6

Dosage Form

-

Strength

2MG/5ML

Approval Date

1982-01-01

6921 / 6 View Details

Active Ingredient

CHLORPHENIRAMINE MALEATE

Application Number

6921

Product Number

6

Dosage Form

-

Strength

2MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1987

22 Oct

Discontinued Application: 19537

Drug Name

CIPRO

Product Number

4

Dosage Form

-

Strength

EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-10-22

19537 / 4 View Details

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

19537

Product Number

4

Dosage Form

-

Strength

EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-10-22

Regulatory Status

Discontinued

1990

26 Dec

Discontinued Application: 19847

Drug Name

CIPRO

Product Number

1

Dosage Form

-

Strength

400MG/40ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-12-26

19847 / 1 View Details

Active Ingredient

CIPROFLOXACIN

Application Number

19847

Product Number

1

Dosage Form

-

Strength

400MG/40ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-12-26

Regulatory Status

Discontinued

1990

26 Dec

Discontinued Application: 19847

Drug Name

CIPRO

Product Number

2

Dosage Form

-

Strength

200MG/20ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-12-26

19847 / 2 View Details

Active Ingredient

CIPROFLOXACIN

Application Number

19847

Product Number

2

Dosage Form

-

Strength

200MG/20ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-12-26

Regulatory Status

Discontinued

1990

26 Dec

Discontinued Application: 19847

Drug Name

CIPRO

Product Number

3

Dosage Form

-

Strength

1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-12-26

19847 / 3 View Details

Active Ingredient

CIPROFLOXACIN

Application Number

19847

Product Number

3

Dosage Form

-

Strength

1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-12-26

Regulatory Status

Discontinued

1990

26 Dec

Discontinued Application: 19857

Drug Name

CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-12-26

19857 / 1 View Details

Active Ingredient

CIPROFLOXACIN

Application Number

19857

Product Number

1

Dosage Form

-

Strength

200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-12-26

Regulatory Status

Discontinued

1990

26 Dec

Discontinued Application: 19857

Drug Name

CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-12-26

19857 / 2 View Details

Active Ingredient

CIPROFLOXACIN

Application Number

19857

Product Number

2

Dosage Form

-

Strength

400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-12-26

Regulatory Status

Discontinued

2002

13 Dec

Discontinued Application: 21473

Drug Name

CIPRO XR

Product Number

1

Dosage Form

-

Strength

212.6MG;EQ 287.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-12-13

21473 / 1 View Details

Active Ingredient

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

Application Number

21473

Product Number

1

Dosage Form

-

Strength

212.6MG;EQ 287.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-12-13

Regulatory Status

Discontinued

2003

28 Aug

Discontinued Application: 21473

Drug Name

CIPRO XR

Product Number

2

Dosage Form

-

Strength

425.2MG;EQ 574.9MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-08-28

21473 / 2 View Details

Active Ingredient

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

Application Number

21473

Product Number

2

Dosage Form

-

Strength

425.2MG;EQ 574.9MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-08-28

Regulatory Status

Discontinued

1986

31 Jan

Discontinued Application: 19408

Drug Name

DIPROLENE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1986-01-31

19408 / 1 View Details

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

19408

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1986-01-31

Regulatory Status

Discontinued

1991

22 Nov

Discontinued Application: 19408

Drug Name

DIPROLENE

Product Number

2

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1991-11-22

19408 / 2 View Details

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

19408

Product Number

2

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1991-11-22

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17536

Drug Name

DIPROSONE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1982-01-01

17536 / 1 View Details

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

17536

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17691

Drug Name

DIPROSONE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1982-01-01

17691 / 1 View Details

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

17691

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17781

Drug Name

DIPROSONE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

17781 / 1 View Details

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

17781

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE **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

Discontinued Application: 17829

Drug Name

DIPROSONE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1982-01-01

17829 / 1 View Details

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

17829

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 11814

Drug Name

DISOMER

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

11814 / 1 View Details

Active Ingredient

DEXBROMPHENIRAMINE MALEATE

Application Number

11814

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 11814

Drug Name

DISOMER

Product Number

2

Dosage Form

-

Strength

2MG/5ML

Approval Date

1982-01-01

11814 / 2 View Details

Active Ingredient

DEXBROMPHENIRAMINE MALEATE

Application Number

11814

Product Number

2

Dosage Form

-

Strength

2MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12394

Drug Name

DISOPHROL

Product Number

2

Dosage Form

-

Strength

2MG;60MG

Approval Date

1982-01-01

12394 / 2 View Details

Active Ingredient

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

Application Number

12394

Product Number

2

Dosage Form

-

Strength

2MG;60MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17575

Drug Name

DTIC-DOME

Product Number

1

Dosage Form

-

Strength

100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17575 / 1 View Details

Active Ingredient

DACARBAZINE

Application Number

17575

Product Number

1

Dosage Form

-

Strength

100MG/VIAL **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

Discontinued Application: 17575

Drug Name

DTIC-DOME

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

17575 / 2 View Details

Active Ingredient

DACARBAZINE

Application Number

17575

Product Number

2

Dosage Form

-

Strength

200MG/VIAL **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

Discontinued Application: 5292

Drug Name

ESTINYL

Product Number

1

Dosage Form

-

Strength

0.02MG

Approval Date

1982-01-01

5292 / 1 View Details

Active Ingredient

ETHINYL ESTRADIOL

Application Number

5292

Product Number

1

Dosage Form

-

Strength

0.02MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 5292

Drug Name

ESTINYL

Product Number

2

Dosage Form

-

Strength

0.05MG

Approval Date

1982-01-01

5292 / 2 View Details

Active Ingredient

ETHINYL ESTRADIOL

Application Number

5292

Product Number

2

Dosage Form

-

Strength

0.05MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 5292

Drug Name

ESTINYL

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

1982-01-01

5292 / 3 View Details

Active Ingredient

ETHINYL ESTRADIOL

Application Number

5292

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 14713

Drug Name

ETRAFON 2-10

Product Number

7

Dosage Form

-

Strength

10MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

14713 / 7 View Details

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

Application Number

14713

Product Number

7

Dosage Form

-

Strength

10MG;2MG **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

Discontinued Application: 14713

Drug Name

ETRAFON 2-25

Product Number

4

Dosage Form

-

Strength

25MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

14713 / 4 View Details

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

Application Number

14713

Product Number

4

Dosage Form

-

Strength

25MG;2MG **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

Discontinued Application: 14713

Drug Name

ETRAFON-A

Product Number

2

Dosage Form

-

Strength

10MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

14713 / 2 View Details

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

Application Number

14713

Product Number

2

Dosage Form

-

Strength

10MG;4MG **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

Discontinued Application: 14713

Drug Name

ETRAFON-FORTE

Product Number

6

Dosage Form

-

Strength

25MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

14713 / 6 View Details

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

Application Number

14713

Product Number

6

Dosage Form

-

Strength

25MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1989

27 Jan

Discontinued Application: 18554

Drug Name

EULEXIN

Product Number

1

Dosage Form

-

Strength

125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1989-01-27

18554 / 1 View Details

Active Ingredient

FLUTAMIDE

Application Number

18554

Product Number

1

Dosage Form

-

Strength

125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1989-01-27

Regulatory Status

Discontinued

1995

21 Dec

Discontinued Application: 20421

Drug Name

FEMSTAT 3

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1995-12-21

20421 / 1 View Details

Active Ingredient

BUTOCONAZOLE NITRATE

Application Number

20421

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1995-12-21

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 50039

Drug Name

GARAMYCIN

Product Number

2

Dosage Form

-

Strength

EQ 0.3% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

50039 / 2 View Details

Active Ingredient

GENTAMICIN SULFATE

Application Number

50039

Product Number

2

Dosage Form

-

Strength

EQ 0.3% BASE **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

Discontinued Application: 50425

Drug Name

GARAMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

1982-01-01

50425 / 1 View Details

Active Ingredient

GENTAMICIN SULFATE

Application Number

50425

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 50505

Drug Name

GARAMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

50505 / 1 View Details

Active Ingredient

GENTAMICIN SULFATE

Application Number

50505

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML **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

Discontinued Application: 60462

Drug Name

GARAMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

60462 / 1 View Details

Active Ingredient

GENTAMICIN SULFATE

Application Number

60462

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE **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

Discontinued Application: 60463

Drug Name

GARAMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

60463 / 1 View Details

Active Ingredient

GENTAMICIN SULFATE

Application Number

60463

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE **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

Discontinued Application: 61716

Drug Name

GARAMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

61716 / 1 View Details

Active Ingredient

GENTAMICIN SULFATE

Application Number

61716

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML **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

Discontinued Application: 61716

Drug Name

GARAMYCIN

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

61716 / 2 View Details

Active Ingredient

GENTAMICIN SULFATE

Application Number

61716

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE/ML **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

Discontinued Application: 61739

Drug Name

GARAMYCIN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

61739 / 1 View Details

Active Ingredient

GENTAMICIN SULFATE

Application Number

61739

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

23 Sep

Discontinued Application: 87728

Drug Name

GASTROVIST

Product Number

1

Dosage Form

-

Strength

66%;10%

Approval Date

1982-09-23

87728 / 1 View Details

Active Ingredient

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

Application Number

87728

Product Number

1

Dosage Form

-

Strength

66%;10%

Approval Date

1982-09-23

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 16996

Drug Name

HYPERSTAT

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

1982-01-01

16996 / 1 View Details

Active Ingredient

DIAZOXIDE

Application Number

16996

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2003

19 Aug

Discontinued Application: 21400

Drug Name

LEVITRA

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-08-19

21400 / 1 View Details

Active Ingredient

VARDENAFIL HYDROCHLORIDE

Application Number

21400

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-08-19

Regulatory Status

Discontinued

2003

19 Aug

Discontinued Application: 21400

Drug Name

LEVITRA

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2003-08-19

21400 / 2 View Details

Active Ingredient

VARDENAFIL HYDROCHLORIDE

Application Number

21400

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2003-08-19

Regulatory Status

Discontinued

2003

19 Aug

Discontinued Application: 21400

Drug Name

LEVITRA

Product Number

3

Dosage Form

-

Strength

EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-08-19

21400 / 3 View Details

Active Ingredient

VARDENAFIL HYDROCHLORIDE

Application Number

21400

Product Number

3

Dosage Form

-

Strength

EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-08-19

Regulatory Status

Discontinued

2003

19 Aug

Discontinued Application: 21400

Drug Name

LEVITRA

Product Number

4

Dosage Form

-

Strength

EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-08-19

21400 / 4 View Details

Active Ingredient

VARDENAFIL HYDROCHLORIDE

Application Number

21400

Product Number

4

Dosage Form

-

Strength

EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-08-19

Regulatory Status

Discontinued

1998

13 Jul

Discontinued Application: 20860

Drug Name

LEVLITE

Product Number

1

Dosage Form

-

Strength

0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-07-13

20860 / 1 View Details

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

20860

Product Number

1

Dosage Form

-

Strength

0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-07-13

Regulatory Status

Discontinued

1998

13 Jul

Discontinued Application: 20860

Drug Name

LEVLITE

Product Number

2

Dosage Form

-

Strength

0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-07-13

20860 / 2 View Details

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

20860

Product Number

2

Dosage Form

-

Strength

0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-07-13

Regulatory Status

Discontinued

1984

17 Feb

Discontinued Application: 18813

Drug Name

LOTRIMIN

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1984-02-17

18813 / 1 View Details

Active Ingredient

CLOTRIMAZOLE

Application Number

18813

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1984-02-17

Regulatory Status

Discontinued

1988

02 Jun

Discontinued Application: 19596

Drug Name

MAGNEVIST

Product Number

1

Dosage Form

-

Strength

469.01MG/ML

Approval Date

1988-06-02

19596 / 1 View Details

Active Ingredient

GADOPENTETATE DIMEGLUMINE

Application Number

19596

Product Number

1

Dosage Form

-

Strength

469.01MG/ML

Approval Date

1988-06-02

Regulatory Status

Discontinued

2000

10 Mar

Discontinued Application: 21037

Drug Name

MAGNEVIST

Product Number

1

Dosage Form

-

Strength

469.01MG/ML

Approval Date

2000-03-10

21037 / 1 View Details

Active Ingredient

GADOPENTETATE DIMEGLUMINE

Application Number

21037

Product Number

1

Dosage Form

-

Strength

469.01MG/ML

Approval Date

2000-03-10

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 16030

Drug Name

MEASURIN

Product Number

2

Dosage Form

-

Strength

650MG

Approval Date

1982-01-01

16030 / 2 View Details

Active Ingredient

ASPIRIN

Application Number

16030

Product Number

2

Dosage Form

-

Strength

650MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 10209

Drug Name

METI-DERM

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

10209 / 2 View Details

Active Ingredient

PREDNISOLONE

Application Number

10209

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 10255

Drug Name

METICORTELONE

Product Number

2

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

10255 / 2 View Details

Active Ingredient

PREDNISOLONE ACETATE

Application Number

10255

Product Number

2

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 9766

Drug Name

METICORTEN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

9766 / 1 View Details

Active Ingredient

PREDNISONE

Application Number

9766

Product Number

1

Dosage Form

-

Strength

5MG **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

Discontinued Application: 9766

Drug Name

METICORTEN

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

9766 / 2 View Details

Active Ingredient

PREDNISONE

Application Number

9766

Product Number

2

Dosage Form

-

Strength

1MG **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

Discontinued Application: 10210

Drug Name

METIMYD

Product Number

1

Dosage Form

-

Strength

0.5%;10%

Approval Date

1982-01-01

10210 / 1 View Details

Active Ingredient

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

Application Number

10210

Product Number

1

Dosage Form

-

Strength

0.5%;10%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984

09 Sep

Discontinued Application: 10210

Drug Name

METIMYD

Product Number

2

Dosage Form

-

Strength

0.5%;10%

Approval Date

1984-09-09

10210 / 2 View Details

Active Ingredient

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

Application Number

10210

Product Number

2

Dosage Form

-

Strength

0.5%;10%

Approval Date

1984-09-09

Regulatory Status

Discontinued

1987

02 Feb

Discontinued Application: 70598

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1987-02-02

70598 / 1 View Details

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

70598

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1987-02-02

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 83834

Drug Name

METRETON

Product Number

1

Dosage Form

-

Strength

EQ 0.5% PHOSPHATE

Approval Date

1982-01-01

83834 / 1 View Details

Active Ingredient

PREDNISOLONE SODIUM PHOSPHATE

Application Number

83834

Product Number

1

Dosage Form

-

Strength

EQ 0.5% PHOSPHATE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1987

02 Sep

Discontinued Application: 70591

Drug Name

MIDOL

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1987-09-02

70591 / 1 View Details

Active Ingredient

IBUPROFEN

Application Number

70591

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1987-09-02

Regulatory Status

Discontinued

1987

02 Sep

Discontinued Application: 70626

Drug Name

MIDOL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1987-09-02

70626 / 1 View Details

Active Ingredient

IBUPROFEN

Application Number

70626

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1987-09-02

Regulatory Status

Discontinued

1987

02 Sep

Discontinued Application: 71001

Drug Name

MIDOL

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1987-09-02

71001 / 1 View Details

Active Ingredient

IBUPROFEN

Application Number

71001

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1987-09-02

Regulatory Status

Discontinued

1987

02 Sep

Discontinued Application: 71002

Drug Name

MIDOL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1987-09-02

71002 / 1 View Details

Active Ingredient

IBUPROFEN

Application Number

71002

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1987-09-02

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 10909

Drug Name

MIRADON

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

10909 / 3 View Details

Active Ingredient

ANISINDIONE

Application Number

10909

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 18181

Drug Name

MYCELEX

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

18181 / 1 View Details

Active Ingredient

CLOTRIMAZOLE

Application Number

18181

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1983

17 Jun

Discontinued Application: 18713

Drug Name

MYCELEX

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1983-06-17

18713 / 1 View Details

Active Ingredient

CLOTRIMAZOLE

Application Number

18713

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1983-06-17

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12265

Drug Name

NAQUA

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

12265 / 1 View Details

Active Ingredient

TRICHLORMETHIAZIDE

Application Number

12265

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12265

Drug Name

NAQUA

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

12265 / 2 View Details

Active Ingredient

TRICHLORMETHIAZIDE

Application Number

12265

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12265

Drug Name

NAQUIVAL

Product Number

3

Dosage Form

-

Strength

0.1MG;4MG

Approval Date

1982-01-01

12265 / 3 View Details

Active Ingredient

RESERPINE; TRICHLORMETHIAZIDE

Application Number

12265

Product Number

3

Dosage Form

-

Strength

0.1MG;4MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1983

28 Feb

Discontinued Application: 50544

Drug Name

NETROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1983-02-28

50544 / 1 View Details

Active Ingredient

NETILMICIN SULFATE

Application Number

50544

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1983-02-28

Regulatory Status

Discontinued

1983

28 Feb

Discontinued Application: 50544

Drug Name

NETROMYCIN

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE/ML

Approval Date

1983-02-28

50544 / 2 View Details

Active Ingredient

NETILMICIN SULFATE

Application Number

50544

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE/ML

Approval Date

1983-02-28

Regulatory Status

Discontinued

1983

28 Feb

Discontinued Application: 50544

Drug Name

NETROMYCIN

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

1983-02-28

50544 / 3 View Details

Active Ingredient

NETILMICIN SULFATE

Application Number

50544

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

1983-02-28

Regulatory Status

Discontinued

1984

01 Aug

Discontinued Application: 18686

Drug Name

NORMODYNE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1984-08-01

18686 / 1 View Details

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

18686

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1984-08-01

Regulatory Status

Discontinued

1987

31 Aug

Discontinued Application: 18687

Drug Name

NORMODYNE

Product Number

1

Dosage Form

-

Strength

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-08-31

18687 / 1 View Details

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

18687

Product Number

1

Dosage Form

-

Strength

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-08-31

Regulatory Status

Discontinued

1984

01 Aug

Discontinued Application: 18687

Drug Name

NORMODYNE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1984-08-01

18687 / 2 View Details

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

18687

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1984-08-01

Regulatory Status

Discontinued

1984

01 Aug

Discontinued Application: 18687

Drug Name

NORMODYNE

Product Number

3

Dosage Form

-

Strength

300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-08-01

18687 / 3 View Details

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

18687

Product Number

3

Dosage Form

-

Strength

300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-08-01

Regulatory Status

Discontinued

1984

01 Aug

Discontinued Application: 18687

Drug Name

NORMODYNE

Product Number

4

Dosage Form

-

Strength

400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-08-01

18687 / 4 View Details

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

18687

Product Number

4

Dosage Form

-

Strength

400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-08-01

Regulatory Status

Discontinued

1987

06 Apr

Discontinued Application: 19046

Drug Name

NORMOZIDE

Product Number

1

Dosage Form

-

Strength

25MG;100MG

Approval Date

1987-04-06

19046 / 1 View Details

Active Ingredient

HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

Application Number

19046

Product Number

1

Dosage Form

-

Strength

25MG;100MG

Approval Date

1987-04-06

Regulatory Status

Discontinued

1987

06 Apr

Discontinued Application: 19046

Drug Name

NORMOZIDE

Product Number

2

Dosage Form

-

Strength

25MG;200MG

Approval Date

1987-04-06

19046 / 2 View Details

Active Ingredient

HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

Application Number

19046

Product Number

2

Dosage Form

-

Strength

25MG;200MG

Approval Date

1987-04-06

Regulatory Status

Discontinued

1987

06 Apr

Discontinued Application: 19046

Drug Name

NORMOZIDE

Product Number

3

Dosage Form

-

Strength

25MG;300MG

Approval Date

1987-04-06

19046 / 3 View Details

Active Ingredient

HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

Application Number

19046

Product Number

3

Dosage Form

-

Strength

25MG;300MG

Approval Date

1987-04-06

Regulatory Status

Discontinued

1987

06 Apr

Discontinued Application: 19046

Drug Name

NORMOZIDE

Product Number

4

Dosage Form

-

Strength

25MG;400MG

Approval Date

1987-04-06

19046 / 4 View Details

Active Ingredient

HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

Application Number

19046

Product Number

4

Dosage Form

-

Strength

25MG;400MG

Approval Date

1987-04-06

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17601

Drug Name

OPTIMINE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

17601 / 1 View Details

Active Ingredient

AZATADINE MALEATE

Application Number

17601

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 80281

Drug Name

ORETON

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

80281 / 1 View Details

Active Ingredient

METHYLTESTOSTERONE

Application Number

80281

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 3158

Drug Name

ORETON METHYL

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

3158 / 1 View Details

Active Ingredient

METHYLTESTOSTERONE

Application Number

3158

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 3158

Drug Name

ORETON METHYL

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

3158 / 2 View Details

Active Ingredient

METHYLTESTOSTERONE

Application Number

3158

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1989

07 Dec

Discontinued Application: 19580

Drug Name

OSMOVIST 190

Product Number

1

Dosage Form

-

Strength

40.6%

Approval Date

1989-12-07

19580 / 1 View Details

Active Ingredient

IOTROLAN

Application Number

19580

Product Number

1

Dosage Form

-

Strength

40.6%

Approval Date

1989-12-07

Regulatory Status

Discontinued

1989

07 Dec

Discontinued Application: 19580

Drug Name

OSMOVIST 240

Product Number

2

Dosage Form

-

Strength

51.3%

Approval Date

1989-12-07

19580 / 2 View Details

Active Ingredient

IOTROLAN

Application Number

19580

Product Number

2

Dosage Form

-

Strength

51.3%

Approval Date

1989-12-07

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 61816

Drug Name

OTOBIONE

Product Number

1

Dosage Form

-

Strength

1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1982-01-01

61816 / 1 View Details

Active Ingredient

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

61816

Product Number

1

Dosage Form

-

Strength

1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 62302

Drug Name

OTOBIOTIC

Product Number

1

Dosage Form

-

Strength

5MG/ML;EQ 10,000 UNITS BASE/ML

Approval Date

1982-01-01

62302 / 1 View Details

Active Ingredient

HYDROCORTISONE; POLYMYXIN B SULFATE

Application Number

62302

Product Number

1

Dosage Form

-

Strength

5MG/ML;EQ 10,000 UNITS BASE/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17736

Drug Name

PAXIPAM

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

17736 / 3 View Details

Active Ingredient

HALAZEPAM

Application Number

17736

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17736

Drug Name

PAXIPAM

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

1982-01-01

17736 / 4 View Details

Active Ingredient

HALAZEPAM

Application Number

17736

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12034

Drug Name

PERMITIL

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

12034 / 1 View Details

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

12034

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12034

Drug Name

PERMITIL

Product Number

4

Dosage Form

-

Strength

2.5MG

Approval Date

1982-01-01

12034 / 4 View Details

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

12034

Product Number

4

Dosage Form

-

Strength

2.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12034

Drug Name

PERMITIL

Product Number

5

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

12034 / 5 View Details

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

12034

Product Number

5

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12034

Drug Name

PERMITIL

Product Number

6

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

12034 / 6 View Details

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

12034

Product Number

6

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12419

Drug Name

PERMITIL

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

12419 / 4 View Details

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

12419

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 16008

Drug Name

PERMITIL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

16008 / 1 View Details

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

16008

Product Number

1

Dosage Form

-

Strength

5MG/ML **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

Discontinued Application: 86835

Drug Name

POLARAMINE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

86835 / 1 View Details

Active Ingredient

DEXCHLORPHENIRAMINE MALEATE

Application Number

86835

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

19 Jul

Discontinued Application: 86837

Drug Name

POLARAMINE

Product Number

1

Dosage Form

-

Strength

2MG/5ML

Approval Date

1982-07-19

86837 / 1 View Details

Active Ingredient

DEXCHLORPHENIRAMINE MALEATE

Application Number

86837

Product Number

1

Dosage Form

-

Strength

2MG/5ML

Approval Date

1982-07-19

Regulatory Status

Discontinued

1986

13 Jun

Discontinued Application: 19439

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1986-06-13

19439 / 1 View Details

Active Ingredient

POTASSIUM CHLORIDE

Application Number

19439

Product Number

1

Dosage Form

-

Strength

20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1986-06-13

Regulatory Status

Discontinued

1986

13 Jun

Discontinued Application: 19439

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1986-06-13

19439 / 2 View Details

Active Ingredient

POTASSIUM CHLORIDE

Application Number

19439

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1986-06-13

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 8114

Drug Name

PRANTAL

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

8114 / 4 View Details

Active Ingredient

DIPHEMANIL METHYLSULFATE

Application Number

8114

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1995

06 Sep

Discontinued Application: 20482

Drug Name

PRECOSE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1995-09-06

20482 / 1 View Details

Active Ingredient

ACARBOSE

Application Number

20482

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1995-09-06

Regulatory Status

Discontinued

1995

06 Sep

Discontinued Application: 20482

Drug Name

PRECOSE

Product Number

2

Dosage Form

-

Strength

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-09-06

20482 / 2 View Details

Active Ingredient

ACARBOSE

Application Number

20482

Product Number

2

Dosage Form

-

Strength

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-09-06

Regulatory Status

Discontinued

1997

29 May

Discontinued Application: 20482

Drug Name

PRECOSE

Product Number

4

Dosage Form

-

Strength

25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-05-29

20482 / 4 View Details

Active Ingredient

ACARBOSE

Application Number

20482

Product Number

4

Dosage Form

-

Strength

25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-05-29

Regulatory Status

Discontinued

1985

06 Aug

Discontinued Application: 70120

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1985-08-06

70120 / 1 View Details

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

70120

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1985-08-06

Regulatory Status

Discontinued

1985

06 Aug

Discontinued Application: 70121

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1985-08-06

70121 / 1 View Details

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

70121

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1985-08-06

Regulatory Status

Discontinued

1985

06 Aug

Discontinued Application: 70122

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1985-08-06

70122 / 1 View Details

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

70122

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1985-08-06

Regulatory Status

Discontinued

1986

29 Oct

Discontinued Application: 70123

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

1986-10-29

70123 / 1 View Details

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

70123

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

1986-10-29

Regulatory Status

Discontinued

1985

06 Aug

Discontinued Application: 70124

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1985-08-06

70124 / 1 View Details

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

70124

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1985-08-06

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17559

Drug Name

PROVENTIL

Product Number

1

Dosage Form

-

Strength

0.09MG/INH

Approval Date

1982-01-01

17559 / 1 View Details

Active Ingredient

ALBUTEROL

Application Number

17559

Product Number

1

Dosage Form

-

Strength

0.09MG/INH

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

07 May

Discontinued Application: 17853

Drug Name

PROVENTIL

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-05-07

17853 / 1 View Details

Active Ingredient

ALBUTEROL SULFATE

Application Number

17853

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-05-07

Regulatory Status

Discontinued

1982

07 May

Discontinued Application: 17853

Drug Name

PROVENTIL

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-05-07

17853 / 2 View Details

Active Ingredient

ALBUTEROL SULFATE

Application Number

17853

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-05-07

Regulatory Status

Discontinued

1983

19 Jan

Discontinued Application: 18062

Drug Name

PROVENTIL

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1983-01-19

18062 / 1 View Details

Active Ingredient

ALBUTEROL SULFATE

Application Number

18062

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1983-01-19

Regulatory Status

Discontinued

1987

14 Jan

Discontinued Application: 19243

Drug Name

PROVENTIL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1987-01-14

19243 / 1 View Details

Active Ingredient

ALBUTEROL SULFATE

Application Number

19243

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1987-01-14

Regulatory Status

Discontinued

1987

14 Jan

Discontinued Application: 19243

Drug Name

PROVENTIL

Product Number

2

Dosage Form

-

Strength

EQ 0.083% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-01-14

19243 / 2 View Details

Active Ingredient

ALBUTEROL SULFATE

Application Number

19243

Product Number

2

Dosage Form

-

Strength

EQ 0.083% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-01-14

Regulatory Status

Discontinued

1987

13 Jul

Discontinued Application: 19383

Drug Name

PROVENTIL

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

1987-07-13

19383 / 1 View Details

Active Ingredient

ALBUTEROL SULFATE

Application Number

19383

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

1987-07-13

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 85978

Drug Name

QUINACT

Product Number

1

Dosage Form

-

Strength

266MG

Approval Date

1982-01-01

85978 / 1 View Details

Active Ingredient

QUINIDINE GLUCONATE

Application Number

85978

Product Number

1

Dosage Form

-

Strength

266MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 86099

Drug Name

QUINACT

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1982-01-01

86099 / 1 View Details

Active Ingredient

QUINIDINE GLUCONATE

Application Number

86099

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 16647

Drug Name

QUINAGLUTE

Product Number

1

Dosage Form

-

Strength

324MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

16647 / 1 View Details

Active Ingredient

QUINIDINE GLUCONATE

Application Number

16647

Product Number

1

Dosage Form

-

Strength

324MG **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

Discontinued Application: 85222

Drug Name

QUINORA

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

85222 / 1 View Details

Active Ingredient

QUINIDINE SULFATE

Application Number

85222

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2003

29 Jul

Discontinued Application: 21546

Drug Name

REBETOL

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2003-07-29

21546 / 1 View Details

Active Ingredient

RIBAVIRIN

Application Number

21546

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2003-07-29

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12155

Drug Name

RELA

Product Number

1

Dosage Form

-

Strength

350MG

Approval Date

1982-01-01

12155 / 1 View Details

Active Ingredient

CARISOPRODOL

Application Number

12155

Product Number

1

Dosage Form

-

Strength

350MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1994

29 Dec

Discontinued Application: 20240

Drug Name

RENORMAX

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

1994-12-29

20240 / 1 View Details

Active Ingredient

SPIRAPRIL HYDROCHLORIDE

Application Number

20240

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

1994-12-29

Regulatory Status

Discontinued

1994

29 Dec

Discontinued Application: 20240

Drug Name

RENORMAX

Product Number

2

Dosage Form

-

Strength

6MG

Approval Date

1994-12-29

20240 / 2 View Details

Active Ingredient

SPIRAPRIL HYDROCHLORIDE

Application Number

20240

Product Number

2

Dosage Form

-

Strength

6MG

Approval Date

1994-12-29

Regulatory Status

Discontinued

1994

29 Dec

Discontinued Application: 20240

Drug Name

RENORMAX

Product Number

3

Dosage Form

-

Strength

12MG

Approval Date

1994-12-29

20240 / 3 View Details

Active Ingredient

SPIRAPRIL HYDROCHLORIDE

Application Number

20240

Product Number

3

Dosage Form

-

Strength

12MG

Approval Date

1994-12-29

Regulatory Status

Discontinued

1994

29 Dec

Discontinued Application: 20240

Drug Name

RENORMAX

Product Number

4

Dosage Form

-

Strength

24MG

Approval Date

1994-12-29

20240 / 4 View Details

Active Ingredient

SPIRAPRIL HYDROCHLORIDE

Application Number

20240

Product Number

4

Dosage Form

-

Strength

24MG

Approval Date

1994-12-29

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 5963

Drug Name

SODIUM SULAMYD

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

5963 / 1 View Details

Active Ingredient

SULFACETAMIDE SODIUM

Application Number

5963

Product Number

1

Dosage Form

-

Strength

10% **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

Discontinued Application: 5963

Drug Name

SODIUM SULAMYD

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

5963 / 2 View Details

Active Ingredient

SULFACETAMIDE SODIUM

Application Number

5963

Product Number

2

Dosage Form

-

Strength

10% **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

Discontinued Application: 5963

Drug Name

SODIUM SULAMYD

Product Number

3

Dosage Form

-

Strength

30% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

5963 / 3 View Details

Active Ingredient

SULFACETAMIDE SODIUM

Application Number

5963

Product Number

3

Dosage Form

-

Strength

30% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

2010

17 Jun

Discontinued Application: 200179

Drug Name

STAXYN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2010-06-17

200179 / 1 View Details

Active Ingredient

VARDENAFIL HYDROCHLORIDE

Application Number

200179

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2010-06-17

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 16000

Drug Name

SULLA

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

16000 / 2 View Details

Active Ingredient

SULFAMETER

Application Number

16000

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 85328

Drug Name

THEO-DUR

Product Number

1

Dosage Form

-

Strength

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

85328 / 1 View Details

Active Ingredient

THEOPHYLLINE

Application Number

85328

Product Number

1

Dosage Form

-

Strength

100MG **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

Discontinued Application: 85328

Drug Name

THEO-DUR

Product Number

2

Dosage Form

-

Strength

300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

85328 / 2 View Details

Active Ingredient

THEOPHYLLINE

Application Number

85328

Product Number

2

Dosage Form

-

Strength

300MG **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

Discontinued Application: 86998

Drug Name

THEO-DUR

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

86998 / 1 View Details

Active Ingredient

THEOPHYLLINE

Application Number

86998

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985

10 Sep

Discontinued Application: 87995

Drug Name

THEO-DUR

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1985-09-10

87995 / 1 View Details

Active Ingredient

THEOPHYLLINE

Application Number

87995

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1985-09-10

Regulatory Status

Discontinued

1985

10 Sep

Discontinued Application: 88015

Drug Name

THEO-DUR

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

1985-09-10

88015 / 1 View Details

Active Ingredient

THEOPHYLLINE

Application Number

88015

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

1985-09-10

Regulatory Status

Discontinued

1985

10 Sep

Discontinued Application: 88016

Drug Name

THEO-DUR

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1985-09-10

88016 / 1 View Details

Active Ingredient

THEOPHYLLINE

Application Number

88016

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1985-09-10

Regulatory Status

Discontinued

1985

10 Sep

Discontinued Application: 88022

Drug Name

THEO-DUR

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1985-09-10

88022 / 1 View Details

Active Ingredient

THEOPHYLLINE

Application Number

88022

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1985-09-10

Regulatory Status

Discontinued

1986

25 Jun

Discontinued Application: 89131

Drug Name

THEO-DUR

Product Number

1

Dosage Form

-

Strength

450MG

Approval Date

1986-06-25

89131 / 1 View Details

Active Ingredient

THEOPHYLLINE

Application Number

89131

Product Number

1

Dosage Form

-

Strength

450MG

Approval Date

1986-06-25

Regulatory Status

Discontinued

1985

31 Jan

Discontinued Application: 87010

Drug Name

THEOVENT

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1985-01-31

87010 / 1 View Details

Active Ingredient

THEOPHYLLINE

Application Number

87010

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1985-01-31

Regulatory Status

Discontinued

1985

31 Jan

Discontinued Application: 87910

Drug Name

THEOVENT

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1985-01-31

87910 / 1 View Details

Active Ingredient

THEOPHYLLINE

Application Number

87910

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1985-01-31

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12254

Drug Name

TINDAL

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

12254 / 2 View Details

Active Ingredient

ACETOPHENAZINE MALEATE

Application Number

12254

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 80381

Drug Name

TREMIN

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

80381 / 1 View Details

Active Ingredient

TRIHEXYPHENIDYL HYDROCHLORIDE

Application Number

80381

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 80381

Drug Name

TREMIN

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

80381 / 3 View Details

Active Ingredient

TRIHEXYPHENIDYL HYDROCHLORIDE

Application Number

80381

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 10775

Drug Name

TRILAFON

Product Number

1

Dosage Form

-

Strength

2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

10775 / 1 View Details

Active Ingredient

PERPHENAZINE

Application Number

10775

Product Number

1

Dosage Form

-

Strength

2MG **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

Discontinued Application: 10775

Drug Name

TRILAFON

Product Number

2

Dosage Form

-

Strength

4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

10775 / 2 View Details

Active Ingredient

PERPHENAZINE

Application Number

10775

Product Number

2

Dosage Form

-

Strength

4MG **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

Discontinued Application: 10775

Drug Name

TRILAFON

Product Number

3

Dosage Form

-

Strength

8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

10775 / 3 View Details

Active Ingredient

PERPHENAZINE

Application Number

10775

Product Number

3

Dosage Form

-

Strength

8MG **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

Discontinued Application: 10775

Drug Name

TRILAFON

Product Number

4

Dosage Form

-

Strength

16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

10775 / 4 View Details

Active Ingredient

PERPHENAZINE

Application Number

10775

Product Number

4

Dosage Form

-

Strength

16MG **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

Discontinued Application: 11213

Drug Name

TRILAFON

Product Number

2

Dosage Form

-

Strength

5MG/ML

Approval Date

1982-01-01

11213 / 2 View Details

Active Ingredient

PERPHENAZINE

Application Number

11213

Product Number

2

Dosage Form

-

Strength

5MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 11294

Drug Name

TRILAFON

Product Number

2

Dosage Form

-

Strength

2MG/5ML

Approval Date

1982-01-01

11294 / 2 View Details

Active Ingredient

PERPHENAZINE

Application Number

11294

Product Number

2

Dosage Form

-

Strength

2MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 11361

Drug Name

TRILAFON

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

1982-01-01

11361 / 2 View Details

Active Ingredient

PERPHENAZINE

Application Number

11361

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 11557

Drug Name

TRILAFON

Product Number

1

Dosage Form

-

Strength

16MG/5ML

Approval Date

1982-01-01

11557 / 1 View Details

Active Ingredient

PERPHENAZINE

Application Number

11557

Product Number

1

Dosage Form

-

Strength

16MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

23 Mar

Discontinued Application: 18506

Drug Name

TRINALIN

Product Number

1

Dosage Form

-

Strength

1MG;120MG

Approval Date

1982-03-23

18506 / 1 View Details

Active Ingredient

AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE

Application Number

18506

Product Number

1

Dosage Form

-

Strength

1MG;120MG

Approval Date

1982-03-23

Regulatory Status

Discontinued

2004

12 Mar

Discontinued Application: 21425

Drug Name

ULTRAVIST (PHARMACY BULK)

Product Number

3

Dosage Form

-

Strength

49.9%

Approval Date

2004-03-12

21425 / 3 View Details

Active Ingredient

IOPROMIDE

Application Number

21425

Product Number

3

Dosage Form

-

Strength

49.9%

Approval Date

2004-03-12

Regulatory Status

Discontinued

1995

10 May

Discontinued Application: 20220

Drug Name

ULTRAVIST 150

Product Number

4

Dosage Form

-

Strength

31.2%

Approval Date

1995-05-10

20220 / 4 View Details

Active Ingredient

IOPROMIDE

Application Number

20220

Product Number

4

Dosage Form

-

Strength

31.2%

Approval Date

1995-05-10

Regulatory Status

Discontinued

1995

10 May

Discontinued Application: 20220

Drug Name

ULTRAVIST 240

Product Number

3

Dosage Form

-

Strength

49.9%

Approval Date

1995-05-10

20220 / 3 View Details

Active Ingredient

IOPROMIDE

Application Number

20220

Product Number

3

Dosage Form

-

Strength

49.9%

Approval Date

1995-05-10

Regulatory Status

Discontinued

2008

18 Nov

Discontinued Application: 20220

Drug Name

ULTRAVIST 300 IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

62.3%

Approval Date

2008-11-18

20220 / 5 View Details

Active Ingredient

IOPROMIDE

Application Number

20220

Product Number

5

Dosage Form

-

Strength

62.3%

Approval Date

2008-11-18

Regulatory Status

Discontinued

1995

04 Jan

Discontinued Application: 89822

Drug Name

UNI-DUR

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1995-01-04

89822 / 1 View Details

Active Ingredient

THEOPHYLLINE

Application Number

89822

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1995-01-04

Regulatory Status

Discontinued

1995

04 Jan

Discontinued Application: 89823

Drug Name

UNI-DUR

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1995-01-04

89823 / 1 View Details

Active Ingredient

THEOPHYLLINE

Application Number

89823

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1995-01-04

Regulatory Status

Discontinued

1982

23 Sep

Discontinued Application: 87729

Drug Name

UROVIST CYSTO

Product Number

1

Dosage Form

-

Strength

30%

Approval Date

1982-09-23

87729 / 1 View Details

Active Ingredient

DIATRIZOATE MEGLUMINE

Application Number

87729

Product Number

1

Dosage Form

-

Strength

30%

Approval Date

1982-09-23

Regulatory Status

Discontinued

1982

23 Sep

Discontinued Application: 87731

Drug Name

UROVIST CYSTO PEDIATRIC

Product Number

1

Dosage Form

-

Strength

30%

Approval Date

1982-09-23

87731 / 1 View Details

Active Ingredient

DIATRIZOATE MEGLUMINE

Application Number

87731

Product Number

1

Dosage Form

-

Strength

30%

Approval Date

1982-09-23

Regulatory Status

Discontinued

1982

23 Sep

Discontinued Application: 87739

Drug Name

UROVIST MEGLUMINE DIU/CT

Product Number

1

Dosage Form

-

Strength

30%

Approval Date

1982-09-23

87739 / 1 View Details

Active Ingredient

DIATRIZOATE MEGLUMINE

Application Number

87739

Product Number

1

Dosage Form

-

Strength

30%

Approval Date

1982-09-23

Regulatory Status

Discontinued

1982

23 Sep

Discontinued Application: 87725

Drug Name

UROVIST SODIUM 300

Product Number

1

Dosage Form

-

Strength

50%

Approval Date

1982-09-23

87725 / 1 View Details

Active Ingredient

DIATRIZOATE SODIUM

Application Number

87725

Product Number

1

Dosage Form

-

Strength

50%

Approval Date

1982-09-23

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 16322

Drug Name

VALISONE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1982-01-01

16322 / 1 View Details

Active Ingredient

BETAMETHASONE VALERATE

Application Number

16322

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 16322

Drug Name

VALISONE

Product Number

2

Dosage Form

-

Strength

EQ 0.01% BASE

Approval Date

1982-01-01

16322 / 2 View Details

Active Ingredient

BETAMETHASONE VALERATE

Application Number

16322

Product Number

2

Dosage Form

-

Strength

EQ 0.01% BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 16740

Drug Name

VALISONE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1982-01-01

16740 / 1 View Details

Active Ingredient

BETAMETHASONE VALERATE

Application Number

16740

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 16932

Drug Name

VALISONE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1982-01-01

16932 / 1 View Details

Active Ingredient

BETAMETHASONE VALERATE

Application Number

16932

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 18521

Drug Name

VANCENASE

Product Number

1

Dosage Form

-

Strength

0.042MG/INH

Approval Date

1982-01-01

18521 / 1 View Details

Active Ingredient

BECLOMETHASONE DIPROPIONATE

Application Number

18521

Product Number

1

Dosage Form

-

Strength

0.042MG/INH

Approval Date

1982-01-01

Regulatory Status

Discontinued

1987

23 Dec

Discontinued Application: 19589

Drug Name

VANCENASE AQ

Product Number

1

Dosage Form

-

Strength

EQ 0.042MG DIPROP/SPRAY

Approval Date

1987-12-23

19589 / 1 View Details

Active Ingredient

BECLOMETHASONE DIPROPIONATE MONOHYDRATE

Application Number

19589

Product Number

1

Dosage Form

-

Strength

EQ 0.042MG DIPROP/SPRAY

Approval Date

1987-12-23

Regulatory Status

Discontinued

1996

26 Jun

Discontinued Application: 20469

Drug Name

VANCENASE AQ

Product Number

1

Dosage Form

-

Strength

EQ 0.084MG DIPROP/SPRAY

Approval Date

1996-06-26

20469 / 1 View Details

Active Ingredient

BECLOMETHASONE DIPROPIONATE MONOHYDRATE

Application Number

20469

Product Number

1

Dosage Form

-

Strength

EQ 0.084MG DIPROP/SPRAY

Approval Date

1996-06-26

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17573

Drug Name

VANCERIL

Product Number

1

Dosage Form

-

Strength

0.042MG/INH

Approval Date

1982-01-01

17573 / 1 View Details

Active Ingredient

BECLOMETHASONE DIPROPIONATE

Application Number

17573

Product Number

1

Dosage Form

-

Strength

0.042MG/INH

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996

24 Dec

Discontinued Application: 20486

Drug Name

VANCERIL DOUBLE STRENGTH

Product Number

1

Dosage Form

-

Strength

0.084MG/INH

Approval Date

1996-12-24

20486 / 1 View Details

Active Ingredient

BECLOMETHASONE DIPROPIONATE

Application Number

20486

Product Number

1

Dosage Form

-

Strength

0.084MG/INH

Approval Date

1996-12-24

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 7012

Drug Name

VI-TWEL

Product Number

2

Dosage Form

-

Strength

1MG/ML

Approval Date

1982-01-01

7012 / 2 View Details

Active Ingredient

CYANOCOBALAMIN

Application Number

7012

Product Number

2

Dosage Form

-

Strength

1MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

Bayer AG Discontinued
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