AbbVie Inc Discontinued
FDA Approved Drugs

AbbVie Inc Discontinued

FDA Approved Drugs Database

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

Discontinued
  • Total Records 158
  • Latest Approval Date Oct 28, 2021
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
301
View
Unclassified
19
View
Discontinued
158
View
OTC
2
View
RX
122
View
Company Overview

Company

AbbVie Inc Discontinued

Country

U.S.A

Social Profiles

LinkedIn X / Twitter
Company Snapshot

AbbVie Inc Discontinued

1 North Waukegan Road North Chicago, IL 60064

U.S.A

www.abbvie.com/ abbviecontractmfg@abbvie.com View on Map
FDA Approved Drug Records ( 158 records )
1999
26 Jul
Discontinued Application: 75114

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1999-07-26

75114 / 1

Active Ingredient

ACYCLOVIR SODIUM

Application Number

75114

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1999-07-26

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12003

Drug Name

AKINETON

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

12003 / 1

Active Ingredient

BIPERIDEN HYDROCHLORIDE

Application Number

12003

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12418

Drug Name

AKINETON

Product Number

2

Dosage Form

-

Strength

5MG/ML

Approval Date

1982-01-01

12418 / 2

Active Ingredient

BIPERIDEN LACTATE

Application Number

12418

Product Number

2

Dosage Form

-

Strength

5MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996
20 Dec
Discontinued Application: 20655

Drug Name

ALORA

Product Number

1

Dosage Form

-

Strength

0.05MG/24HR

Approval Date

1996-12-20

20655 / 1

Active Ingredient

ESTRADIOL

Application Number

20655

Product Number

1

Dosage Form

-

Strength

0.05MG/24HR

Approval Date

1996-12-20

Regulatory Status

Discontinued

1996
20 Dec
Discontinued Application: 20655

Drug Name

ALORA

Product Number

2

Dosage Form

-

Strength

0.075MG/24HR

Approval Date

1996-12-20

20655 / 2

Active Ingredient

ESTRADIOL

Application Number

20655

Product Number

2

Dosage Form

-

Strength

0.075MG/24HR

Approval Date

1996-12-20

Regulatory Status

Discontinued

1996
20 Dec
Discontinued Application: 20655

Drug Name

ALORA

Product Number

3

Dosage Form

-

Strength

0.1MG/24HR

Approval Date

1996-12-20

20655 / 3

Active Ingredient

ESTRADIOL

Application Number

20655

Product Number

3

Dosage Form

-

Strength

0.1MG/24HR

Approval Date

1996-12-20

Regulatory Status

Discontinued

2002
05 Apr
Discontinued Application: 20655

Drug Name

ALORA

Product Number

4

Dosage Form

-

Strength

0.025MG/24HR

Approval Date

2002-04-05

20655 / 4

Active Ingredient

ESTRADIOL

Application Number

20655

Product Number

4

Dosage Form

-

Strength

0.025MG/24HR

Approval Date

2002-04-05

Regulatory Status

Discontinued

1985
31 Jan
Discontinued Application: 5932

Drug Name

AMINOSOL 5%

Product Number

12

Dosage Form

-

Strength

5%

Approval Date

1985-01-31

5932 / 12

Active Ingredient

PROTEIN HYDROLYSATE

Application Number

5932

Product Number

12

Dosage Form

-

Strength

5%

Approval Date

1985-01-31

Regulatory Status

Discontinued

1995
29 Sep
Discontinued Application: 20489

Drug Name

ANDRODERM

Product Number

1

Dosage Form

-

Strength

2.5MG/24HR

Approval Date

1995-09-29

20489 / 1

Active Ingredient

TESTOSTERONE

Application Number

20489

Product Number

1

Dosage Form

-

Strength

2.5MG/24HR

Approval Date

1995-09-29

Regulatory Status

Discontinued

1997
02 May
Discontinued Application: 20489

Drug Name

ANDRODERM

Product Number

2

Dosage Form

-

Strength

5MG/24HR

Approval Date

1997-05-02

20489 / 2

Active Ingredient

TESTOSTERONE

Application Number

20489

Product Number

2

Dosage Form

-

Strength

5MG/24HR

Approval Date

1997-05-02

Regulatory Status

Discontinued

2011
20 Oct
Discontinued Application: 20489

Drug Name

ANDRODERM

Product Number

3

Dosage Form

-

Strength

2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2011-10-20

20489 / 3

Active Ingredient

TESTOSTERONE

Application Number

20489

Product Number

3

Dosage Form

-

Strength

2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2011-10-20

Regulatory Status

Discontinued

2011
20 Oct
Discontinued Application: 20489

Drug Name

ANDRODERM

Product Number

4

Dosage Form

-

Strength

4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2011-10-20

20489 / 4

Active Ingredient

TESTOSTERONE

Application Number

20489

Product Number

4

Dosage Form

-

Strength

4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2011-10-20

Regulatory Status

Discontinued

2008
29 May
Discontinued Application: 21830

Drug Name

ASACOL HD

Product Number

1

Dosage Form

-

Strength

800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-05-29

21830 / 1

Active Ingredient

MESALAMINE

Application Number

21830

Product Number

1

Dosage Form

-

Strength

800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-05-29

Regulatory Status

Discontinued

1987
30 Jan
Discontinued Application: 71295

Drug Name

ATROPINE

Product Number

1

Dosage Form

-

Strength

EQ 2MG SULFATE/0.7ML

Approval Date

1987-01-30

71295 / 1

Active Ingredient

ATROPINE

Application Number

71295

Product Number

1

Dosage Form

-

Strength

EQ 2MG SULFATE/0.7ML

Approval Date

1987-01-30

Regulatory Status

Discontinued

1982
26 Nov
Discontinued Application: 87847

Drug Name

ATROPINE AND DEMEROL

Product Number

1

Dosage Form

-

Strength

0.4MG/ML;75MG/ML

Approval Date

1982-11-26

87847 / 1

Active Ingredient

ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE

Application Number

87847

Product Number

1

Dosage Form

-

Strength

0.4MG/ML;75MG/ML

Approval Date

1982-11-26

Regulatory Status

Discontinued

1982
26 Nov
Discontinued Application: 87848

Drug Name

ATROPINE AND DEMEROL

Product Number

1

Dosage Form

-

Strength

0.4MG/ML;100MG/ML

Approval Date

1982-11-26

87848 / 1

Active Ingredient

ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE

Application Number

87848

Product Number

1

Dosage Form

-

Strength

0.4MG/ML;100MG/ML

Approval Date

1982-11-26

Regulatory Status

Discontinued

1982
26 Nov
Discontinued Application: 87853

Drug Name

ATROPINE AND DEMEROL

Product Number

1

Dosage Form

-

Strength

0.4MG/ML;50MG/ML

Approval Date

1982-11-26

87853 / 1

Active Ingredient

ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE

Application Number

87853

Product Number

1

Dosage Form

-

Strength

0.4MG/ML;50MG/ML

Approval Date

1982-11-26

Regulatory Status

Discontinued

1982
23 Apr
Discontinued Application: 18117

Drug Name

AZMACORT

Product Number

1

Dosage Form

-

Strength

0.1MG/INH

Approval Date

1982-04-23

18117 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

18117

Product Number

1

Dosage Form

-

Strength

0.1MG/INH

Approval Date

1982-04-23

Regulatory Status

Discontinued

1984
15 Oct
Discontinued Application: 8370

Drug Name

BENTYL

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1984-10-15

Active Ingredient

DICYCLOMINE HYDROCHLORIDE

Application Number

8370

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1984-10-15

Regulatory Status

Discontinued

1984
15 Oct
Discontinued Application: 8370

Drug Name

BENTYL PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1984-10-15

Active Ingredient

DICYCLOMINE HYDROCHLORIDE

Application Number

8370

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1984-10-15

Regulatory Status

Discontinued

1991
31 Oct
Discontinued Application: 50662

Drug Name

BIAXIN

Product Number

1

Dosage Form

-

Strength

250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-10-31

50662 / 1

Active Ingredient

CLARITHROMYCIN

Application Number

50662

Product Number

1

Dosage Form

-

Strength

250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-10-31

Regulatory Status

Discontinued

1991
31 Oct
Discontinued Application: 50662

Drug Name

BIAXIN

Product Number

2

Dosage Form

-

Strength

500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-10-31

50662 / 2

Active Ingredient

CLARITHROMYCIN

Application Number

50662

Product Number

2

Dosage Form

-

Strength

500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-10-31

Regulatory Status

Discontinued

1993
23 Dec
Discontinued Application: 50698

Drug Name

BIAXIN

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

1993-12-23

50698 / 1

Active Ingredient

CLARITHROMYCIN

Application Number

50698

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

1993-12-23

Regulatory Status

Discontinued

1993
23 Dec
Discontinued Application: 50698

Drug Name

BIAXIN

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

1993-12-23

50698 / 2

Active Ingredient

CLARITHROMYCIN

Application Number

50698

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

1993-12-23

Regulatory Status

Discontinued

1998
30 Sep
Discontinued Application: 50698

Drug Name

BIAXIN

Product Number

3

Dosage Form

-

Strength

187MG/5ML

Approval Date

1998-09-30

50698 / 3

Active Ingredient

CLARITHROMYCIN

Application Number

50698

Product Number

3

Dosage Form

-

Strength

187MG/5ML

Approval Date

1998-09-30

Regulatory Status

Discontinued

2000
03 Mar
Discontinued Application: 50775

Drug Name

BIAXIN XL

Product Number

1

Dosage Form

-

Strength

500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-03-03

50775 / 1

Active Ingredient

CLARITHROMYCIN

Application Number

50775

Product Number

1

Dosage Form

-

Strength

500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-03-03

Regulatory Status

Discontinued

2016
03 Jun
Discontinued Application: 206302

Drug Name

BYVALSON

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;80MG

Approval Date

2016-06-03

206302 / 1

Active Ingredient

NEBIVOLOL HYDROCHLORIDE; VALSARTAN

Application Number

206302

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;80MG

Approval Date

2016-06-03

Regulatory Status

Discontinued

1986
25 Sep
Discontinued Application: 18874

Drug Name

CALCIJEX

Product Number

1

Dosage Form

-

Strength

0.001MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1986-09-25

18874 / 1

Active Ingredient

CALCITRIOL

Application Number

18874

Product Number

1

Dosage Form

-

Strength

0.001MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1986-09-25

Regulatory Status

Discontinued

1986
25 Sep
Discontinued Application: 18874

Drug Name

CALCIJEX

Product Number

2

Dosage Form

-

Strength

0.002MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1986-09-25

18874 / 2

Active Ingredient

CALCITRIOL

Application Number

18874

Product Number

2

Dosage Form

-

Strength

0.002MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1986-09-25

Regulatory Status

Discontinued

2001
05 Jan
Discontinued Application: 21252

Drug Name

CANASA

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2001-01-05

21252 / 1

Active Ingredient

MESALAMINE

Application Number

21252

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2001-01-05

Regulatory Status

Discontinued

1993
16 Dec
Discontinued Application: 19183

Drug Name

CARAFATE

Product Number

1

Dosage Form

-

Strength

1GM/10ML

Approval Date

1993-12-16

19183 / 1

Active Ingredient

SUCRALFATE

Application Number

19183

Product Number

1

Dosage Form

-

Strength

1GM/10ML

Approval Date

1993-12-16

Regulatory Status

Discontinued

1988
28 Dec
Discontinued Application: 19204

Drug Name

CARTROL

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1988-12-28

19204 / 1

Active Ingredient

CARTEOLOL HYDROCHLORIDE

Application Number

19204

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1988-12-28

Regulatory Status

Discontinued

1988
28 Dec
Discontinued Application: 19204

Drug Name

CARTROL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1988-12-28

19204 / 2

Active Ingredient

CARTEOLOL HYDROCHLORIDE

Application Number

19204

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1988-12-28

Regulatory Status

Discontinued

1988
28 Dec
Discontinued Application: 19204

Drug Name

CARTROL

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

1988-12-28

19204 / 3

Active Ingredient

CARTEOLOL HYDROCHLORIDE

Application Number

19204

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

1988-12-28

Regulatory Status

Discontinued

1998
17 Jul
Discontinued Application: 20822

Drug Name

CELEXA

Product Number

4

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

1998-07-17

20822 / 4

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

20822

Product Number

4

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

1998-07-17

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12302

Drug Name

CHOLOXIN

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

12302 / 2

Active Ingredient

DEXTROTHYROXINE SODIUM

Application Number

12302

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12302

Drug Name

CHOLOXIN

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

12302 / 4

Active Ingredient

DEXTROTHYROXINE SODIUM

Application Number

12302

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12302

Drug Name

CHOLOXIN

Product Number

5

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

12302 / 5

Active Ingredient

DEXTROTHYROXINE SODIUM

Application Number

12302

Product Number

5

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12302

Drug Name

CHOLOXIN

Product Number

6

Dosage Form

-

Strength

6MG

Approval Date

1982-01-01

12302 / 6

Active Ingredient

DEXTROTHYROXINE SODIUM

Application Number

12302

Product Number

6

Dosage Form

-

Strength

6MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1997
31 Jul
Discontinued Application: 20701

Drug Name

CRINONE

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1997-07-31

20701 / 1

Active Ingredient

PROGESTERONE

Application Number

20701

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1997-07-31

Regulatory Status

Discontinued

2000
03 Mar
Discontinued Application: 65025

Drug Name

CYCLOSPORINE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2000-03-03

65025 / 1

Active Ingredient

CYCLOSPORINE

Application Number

65025

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2000-03-03

Regulatory Status

Discontinued

2013
01 Feb
Discontinued Application: 204412

Drug Name

DELZICOL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2013-02-01

204412 / 1

Active Ingredient

MESALAMINE

Application Number

204412

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2013-02-01

Regulatory Status

Discontinued

1996
30 Dec
Discontinued Application: 20593

Drug Name

DEPACON

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1996-12-30

20593 / 1

Active Ingredient

VALPROATE SODIUM

Application Number

20593

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1996-12-30

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18081

Drug Name

DEPAKENE

Product Number

1

Dosage Form

-

Strength

250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

18081 / 1

Active Ingredient

VALPROIC ACID

Application Number

18081

Product Number

1

Dosage Form

-

Strength

250MG **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: 18082

Drug Name

DEPAKENE

Product Number

1

Dosage Form

-

Strength

250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

18082 / 1

Active Ingredient

VALPROIC ACID

Application Number

18082

Product Number

1

Dosage Form

-

Strength

250MG/5ML **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: 6044

Drug Name

DIASONE SODIUM

Product Number

3

Dosage Form

-

Strength

165MG

Approval Date

1982-01-01

Active Ingredient

SULFOXONE SODIUM

Application Number

6044

Product Number

3

Dosage Form

-

Strength

165MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 5545

Drug Name

DICUMAROL

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Active Ingredient

DICUMAROL

Application Number

5545

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 5545

Drug Name

DICUMAROL

Product Number

4

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Active Ingredient

DICUMAROL

Application Number

5545

Product Number

4

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 5545

Drug Name

DICUMAROL

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Active Ingredient

DICUMAROL

Application Number

5545

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2004
22 Dec
Discontinued Application: 21513

Drug Name

ENABLEX

Product Number

1

Dosage Form

-

Strength

EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-12-22

21513 / 1

Active Ingredient

DARIFENACIN HYDROBROMIDE

Application Number

21513

Product Number

1

Dosage Form

-

Strength

EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-12-22

Regulatory Status

Discontinued

2004
22 Dec
Discontinued Application: 21513

Drug Name

ENABLEX

Product Number

2

Dosage Form

-

Strength

EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-12-22

21513 / 2

Active Ingredient

DARIFENACIN HYDROBROMIDE

Application Number

21513

Product Number

2

Dosage Form

-

Strength

EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-12-22

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12524

Drug Name

ENDURON

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

12524 / 1

Active Ingredient

METHYCLOTHIAZIDE

Application Number

12524

Product Number

1

Dosage Form

-

Strength

2.5MG **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: 12524

Drug Name

ENDURON

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1982-01-01

12524 / 4

Active Ingredient

METHYCLOTHIAZIDE

Application Number

12524

Product Number

4

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

2001
17 Dec
Discontinued Application: 75729

Drug Name

FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

2001-12-17

75729 / 1

Active Ingredient

FAMOTIDINE

Application Number

75729

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

2001-12-17

Regulatory Status

Discontinued

2009
27 Jan
Discontinued Application: 22204

Drug Name

GELNIQUE

Product Number

1

Dosage Form

-

Strength

10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2009-01-27

22204 / 1

Active Ingredient

OXYBUTYNIN CHLORIDE

Application Number

22204

Product Number

1

Dosage Form

-

Strength

10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2009-01-27

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8322

Drug Name

GEMONIL

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Active Ingredient

METHARBITAL

Application Number

8322

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2000
12 May
Discontinued Application: 65003

Drug Name

GENGRAF

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2000-05-12

65003 / 2

Active Ingredient

CYCLOSPORINE

Application Number

65003

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2000-05-12

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10796

Drug Name

HARMONYL

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

10796 / 1

Active Ingredient

DESERPIDINE

Application Number

10796

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10796

Drug Name

HARMONYL

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

10796 / 2

Active Ingredient

DESERPIDINE

Application Number

10796

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1997
30 Apr
Discontinued Application: 74638

Drug Name

IOPAMIDOL-300

Product Number

1

Dosage Form

-

Strength

61%

Approval Date

1997-04-30

74638 / 1

Active Ingredient

IOPAMIDOL

Application Number

74638

Product Number

1

Dosage Form

-

Strength

61%

Approval Date

1997-04-30

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18279

Drug Name

K-TAB

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

18279 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

18279

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1988
01 Aug
Discontinued Application: 18279

Drug Name

K-TAB

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1988-08-01

18279 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

18279

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1988-08-01

Regulatory Status

Discontinued

2013
25 Nov
Discontinued Application: 18279

Drug Name

K-TAB

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2013-11-25

18279 / 3

Active Ingredient

POTASSIUM CHLORIDE

Application Number

18279

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2013-11-25

Regulatory Status

Discontinued

2000
15 Sep
Discontinued Application: 21226

Drug Name

KALETRA

Product Number

1

Dosage Form

-

Strength

133.3MG;33.3MG

Approval Date

2000-09-15

21226 / 1

Active Ingredient

LOPINAVIR; RITONAVIR

Application Number

21226

Product Number

1

Dosage Form

-

Strength

133.3MG;33.3MG

Approval Date

2000-09-15

Regulatory Status

Discontinued

2002
27 Nov
Discontinued Application: 21365

Drug Name

LEXAPRO

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2002-11-27

21365 / 1

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

21365

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2002-11-27

Regulatory Status

Discontinued

1993
31 Dec
Discontinued Application: 19304

Drug Name

LIPIDIL

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1993-12-31

19304 / 1

Active Ingredient

FENOFIBRATE

Application Number

19304

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1993-12-31

Regulatory Status

Discontinued

2001
16 Mar
Discontinued Application: 21275

Drug Name

LUMIGAN

Product Number

1

Dosage Form

-

Strength

0.03% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-03-16

21275 / 1

Active Ingredient

BIMATOPROST

Application Number

21275

Product Number

1

Dosage Form

-

Strength

0.03% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-03-16

Regulatory Status

Discontinued

2012
14 Dec
Discontinued Application: 203696

Drug Name

LUPANETA PACK

Product Number

1

Dosage Form

-

Strength

3.75MG/VIAL,N/A;N/A,5MG

Approval Date

2012-12-14

203696 / 1

Active Ingredient

LEUPROLIDE ACETATE; NORETHINDRONE ACETATE

Application Number

203696

Product Number

1

Dosage Form

-

Strength

3.75MG/VIAL,N/A;N/A,5MG

Approval Date

2012-12-14

Regulatory Status

Discontinued

2012
14 Dec
Discontinued Application: 203696

Drug Name

LUPANETA PACK

Product Number

2

Dosage Form

-

Strength

11.25MG/VIAL,N/A;N/A,5MG

Approval Date

2012-12-14

203696 / 2

Active Ingredient

LEUPROLIDE ACETATE; NORETHINDRONE ACETATE

Application Number

203696

Product Number

2

Dosage Form

-

Strength

11.25MG/VIAL,N/A;N/A,5MG

Approval Date

2012-12-14

Regulatory Status

Discontinued

1985
09 Apr
Discontinued Application: 19010

Drug Name

LUPRON

Product Number

1

Dosage Form

-

Strength

14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-04-09

19010 / 1

Active Ingredient

LEUPROLIDE ACETATE

Application Number

19010

Product Number

1

Dosage Form

-

Strength

14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-04-09

Regulatory Status

Discontinued

1990
22 Oct
Discontinued Application: 20011

Drug Name

LUPRON DEPOT

Product Number

1

Dosage Form

-

Strength

3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-10-22

20011 / 1

Active Ingredient

LEUPROLIDE ACETATE

Application Number

20011

Product Number

1

Dosage Form

-

Strength

3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-10-22

Regulatory Status

Discontinued

1993
16 Apr
Discontinued Application: 20263

Drug Name

LUPRON DEPOT-PED KIT

Product Number

3

Dosage Form

-

Strength

3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-04-16

20263 / 3

Active Ingredient

LEUPROLIDE ACETATE

Application Number

20263

Product Number

3

Dosage Form

-

Strength

3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-04-16

Regulatory Status

Discontinued

1993
16 Apr
Discontinued Application: 20263

Drug Name

LUPRON DEPOT-PED KIT

Product Number

4

Dosage Form

-

Strength

7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-04-16

20263 / 4

Active Ingredient

LEUPROLIDE ACETATE

Application Number

20263

Product Number

4

Dosage Form

-

Strength

7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-04-16

Regulatory Status

Discontinued

1996
26 Apr
Discontinued Application: 20528

Drug Name

MAVIK

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1996-04-26

20528 / 1

Active Ingredient

TRANDOLAPRIL

Application Number

20528

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1996-04-26

Regulatory Status

Discontinued

1996
26 Apr
Discontinued Application: 20528

Drug Name

MAVIK

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1996-04-26

20528 / 2

Active Ingredient

TRANDOLAPRIL

Application Number

20528

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1996-04-26

Regulatory Status

Discontinued

1996
26 Apr
Discontinued Application: 20528

Drug Name

MAVIK

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1996-04-26

20528 / 3

Active Ingredient

TRANDOLAPRIL

Application Number

20528

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1996-04-26

Regulatory Status

Discontinued

1992
22 Jan
Discontinued Application: 20098

Drug Name

MIVACRON

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1992-01-22

20098 / 1

Active Ingredient

MIVACURIUM CHLORIDE

Application Number

20098

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1992-01-22

Regulatory Status

Discontinued

1992
22 Jan
Discontinued Application: 20098

Drug Name

MIVACRON

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE/5ML (EQ 2MG BASE/ML)

Approval Date

1992-01-22

20098 / 4

Active Ingredient

MIVACURIUM CHLORIDE

Application Number

20098

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE/5ML (EQ 2MG BASE/ML)

Approval Date

1992-01-22

Regulatory Status

Discontinued

1992
22 Jan
Discontinued Application: 20098

Drug Name

MIVACRON

Product Number

5

Dosage Form

-

Strength

EQ 20MG BASE/10ML (EQ 2MG BASE/ML)

Approval Date

1992-01-22

20098 / 5

Active Ingredient

MIVACURIUM CHLORIDE

Application Number

20098

Product Number

5

Dosage Form

-

Strength

EQ 20MG BASE/10ML (EQ 2MG BASE/ML)

Approval Date

1992-01-22

Regulatory Status

Discontinued

1992
22 Jan
Discontinued Application: 20098

Drug Name

MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 0.5MG BASE/ML

Approval Date

1992-01-22

20098 / 2

Active Ingredient

MIVACURIUM CHLORIDE

Application Number

20098

Product Number

2

Dosage Form

-

Strength

EQ 0.5MG BASE/ML

Approval Date

1992-01-22

Regulatory Status

Discontinued

1992
22 Jan
Discontinued Application: 20098

Drug Name

MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE/100ML

Approval Date

1992-01-22

20098 / 3

Active Ingredient

MIVACURIUM CHLORIDE

Application Number

20098

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE/100ML

Approval Date

1992-01-22

Regulatory Status

Discontinued

1993
12 Mar
Discontinued Application: 20200

Drug Name

NALBUPHINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1.5MG/ML

Approval Date

1993-03-12

20200 / 1

Active Ingredient

NALBUPHINE HYDROCHLORIDE

Application Number

20200

Product Number

1

Dosage Form

-

Strength

1.5MG/ML

Approval Date

1993-03-12

Regulatory Status

Discontinued

2003
16 Oct
Discontinued Application: 21487

Drug Name

NAMENDA

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2003-10-16

21487 / 1

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

21487

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2003-10-16

Regulatory Status

Discontinued

2003
16 Oct
Discontinued Application: 21487

Drug Name

NAMENDA

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2003-10-16

21487 / 2

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

21487

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2003-10-16

Regulatory Status

Discontinued

2010
21 Jun
Discontinued Application: 22525

Drug Name

NAMENDA XR

Product Number

1

Dosage Form

-

Strength

7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2010-06-21

22525 / 1

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

22525

Product Number

1

Dosage Form

-

Strength

7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2010-06-21

Regulatory Status

Discontinued

2010
21 Jun
Discontinued Application: 22525

Drug Name

NAMENDA XR

Product Number

2

Dosage Form

-

Strength

14MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2010-06-21

22525 / 2

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

22525

Product Number

2

Dosage Form

-

Strength

14MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2010-06-21

Regulatory Status

Discontinued

2010
21 Jun
Discontinued Application: 22525

Drug Name

NAMENDA XR

Product Number

3

Dosage Form

-

Strength

21MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2010-06-21

22525 / 3

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

22525

Product Number

3

Dosage Form

-

Strength

21MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2010-06-21

Regulatory Status

Discontinued

2010
21 Jun
Discontinued Application: 22525

Drug Name

NAMENDA XR

Product Number

4

Dosage Form

-

Strength

28MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2010-06-21

22525 / 4

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

22525

Product Number

4

Dosage Form

-

Strength

28MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2010-06-21

Regulatory Status

Discontinued

1997
28 Jul
Discontinued Application: 20381

Drug Name

NIASPAN

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

1997-07-28

20381 / 1

Active Ingredient

NIACIN

Application Number

20381

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

1997-07-28

Regulatory Status

Discontinued

1997
28 Jul
Discontinued Application: 20381

Drug Name

NIASPAN

Product Number

2

Dosage Form

-

Strength

500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-07-28

20381 / 2

Active Ingredient

NIACIN

Application Number

20381

Product Number

2

Dosage Form

-

Strength

500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-07-28

Regulatory Status

Discontinued

1997
28 Jul
Discontinued Application: 20381

Drug Name

NIASPAN

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1997-07-28

20381 / 3

Active Ingredient

NIACIN

Application Number

20381

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1997-07-28

Regulatory Status

Discontinued

1997
28 Jul
Discontinued Application: 20381

Drug Name

NIASPAN

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1997-07-28

20381 / 4

Active Ingredient

NIACIN

Application Number

20381

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1997-07-28

Regulatory Status

Discontinued

1997
28 Jul
Discontinued Application: 20381

Drug Name

NIASPAN TITRATION STARTER PACK

Product Number

5

Dosage Form

-

Strength

375MG;500MG;750MG

Approval Date

1997-07-28

20381 / 5

Active Ingredient

NIACIN

Application Number

20381

Product Number

5

Dosage Form

-

Strength

375MG;500MG;750MG

Approval Date

1997-07-28

Regulatory Status

Discontinued

1995
15 Dec
Discontinued Application: 20551

Drug Name

NIMBEX

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

1995-12-15

20551 / 1

Active Ingredient

CISATRACURIUM BESYLATE

Application Number

20551

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

1995-12-15

Regulatory Status

Discontinued

1995
15 Dec
Discontinued Application: 20551

Drug Name

NIMBEX PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1995-12-15

20551 / 2

Active Ingredient

CISATRACURIUM BESYLATE

Application Number

20551

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1995-12-15

Regulatory Status

Discontinued

1995
15 Dec
Discontinued Application: 20551

Drug Name

NIMBEX PRESERVATIVE FREE

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1995-12-15

20551 / 3

Active Ingredient

CISATRACURIUM BESYLATE

Application Number

20551

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1995-12-15

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18450

Drug Name

NITROPRESS

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

18450 / 1

Active Ingredient

SODIUM NITROPRUSSIDE

Application Number

18450

Product Number

1

Dosage Form

-

Strength

50MG/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: 6905

Drug Name

NORISODRINE

Product Number

2

Dosage Form

-

Strength

25%

Approval Date

1982-01-01

Active Ingredient

ISOPROTERENOL SULFATE

Application Number

6905

Product Number

2

Dosage Form

-

Strength

25%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 6905

Drug Name

NORISODRINE

Product Number

3

Dosage Form

-

Strength

10%

Approval Date

1982-01-01

Active Ingredient

ISOPROTERENOL SULFATE

Application Number

6905

Product Number

3

Dosage Form

-

Strength

10%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996
01 Mar
Discontinued Application: 20659

Drug Name

NORVIR

Product Number

1

Dosage Form

-

Strength

80MG/ML

Approval Date

1996-03-01

20659 / 1

Active Ingredient

RITONAVIR

Application Number

20659

Product Number

1

Dosage Form

-

Strength

80MG/ML

Approval Date

1996-03-01

Regulatory Status

Discontinued

1999
29 Jun
Discontinued Application: 20945

Drug Name

NORVIR

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1999-06-29

20945 / 1

Active Ingredient

RITONAVIR

Application Number

20945

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1999-06-29

Regulatory Status

Discontinued

1991
07 Mar
Discontinued Application: 19946

Drug Name

NUROMAX

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

1991-03-07

19946 / 1

Active Ingredient

DOXACURIUM CHLORIDE

Application Number

19946

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

1991-03-07

Regulatory Status

Discontinued

1997
04 Dec
Discontinued Application: 50739

Drug Name

OMNICEF

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1997-12-04

50739 / 1

Active Ingredient

CEFDINIR

Application Number

50739

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1997-12-04

Regulatory Status

Discontinued

1997
04 Dec
Discontinued Application: 50749

Drug Name

OMNICEF

Product Number

1

Dosage Form

-

Strength

125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-12-04

50749 / 1

Active Ingredient

CEFDINIR

Application Number

50749

Product Number

1

Dosage Form

-

Strength

125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-12-04

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 50749

Drug Name

OMNICEF

Product Number

2

Dosage Form

-

Strength

250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-07-29

50749 / 2

Active Ingredient

CEFDINIR

Application Number

50749

Product Number

2

Dosage Form

-

Strength

250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-07-29

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11971

Drug Name

ORETIC

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

11971 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

11971

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11971

Drug Name

ORETIC

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

11971 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

11971

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12148

Drug Name

ORETICYL 25

Product Number

1

Dosage Form

-

Strength

0.125MG;25MG

Approval Date

1982-01-01

12148 / 1

Active Ingredient

DESERPIDINE; HYDROCHLOROTHIAZIDE

Application Number

12148

Product Number

1

Dosage Form

-

Strength

0.125MG;25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12148

Drug Name

ORETICYL 50

Product Number

3

Dosage Form

-

Strength

0.125MG;50MG

Approval Date

1982-01-01

12148 / 3

Active Ingredient

DESERPIDINE; HYDROCHLOROTHIAZIDE

Application Number

12148

Product Number

3

Dosage Form

-

Strength

0.125MG;50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12148

Drug Name

ORETICYL FORTE

Product Number

2

Dosage Form

-

Strength

0.25MG;25MG

Approval Date

1982-01-01

12148 / 2

Active Ingredient

DESERPIDINE; HYDROCHLOROTHIAZIDE

Application Number

12148

Product Number

2

Dosage Form

-

Strength

0.25MG;25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 6800

Drug Name

PARADIONE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

Active Ingredient

PARAMETHADIONE

Application Number

6800

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 6800

Drug Name

PARADIONE

Product Number

2

Dosage Form

-

Strength

300MG/ML

Approval Date

1982-01-01

Active Ingredient

PARAMETHADIONE

Application Number

6800

Product Number

2

Dosage Form

-

Strength

300MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 6800

Drug Name

PARADIONE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

1982-01-01

Active Ingredient

PARAMETHADIONE

Application Number

6800

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 7707

Drug Name

PHENURONE

Product Number

1

Dosage Form

-

Strength

500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Active Ingredient

PHENACEMIDE

Application Number

7707

Product Number

1

Dosage Form

-

Strength

500MG **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: 10021

Drug Name

PLACIDYL

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

10021 / 2

Active Ingredient

ETHCHLORVYNOL

Application Number

10021

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10021

Drug Name

PLACIDYL

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

10021 / 4

Active Ingredient

ETHCHLORVYNOL

Application Number

10021

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10021

Drug Name

PLACIDYL

Product Number

7

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

10021 / 7

Active Ingredient

ETHCHLORVYNOL

Application Number

10021

Product Number

7

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10021

Drug Name

PLACIDYL

Product Number

10

Dosage Form

-

Strength

750MG

Approval Date

1982-01-01

10021 / 10

Active Ingredient

ETHCHLORVYNOL

Application Number

10021

Product Number

10

Dosage Form

-

Strength

750MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2008
08 Oct
Discontinued Application: 22206

Drug Name

RAPAFLO

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2008-10-08

22206 / 1

Active Ingredient

SILODOSIN

Application Number

22206

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2008-10-08

Regulatory Status

Discontinued

2008
08 Oct
Discontinued Application: 22206

Drug Name

RAPAFLO

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2008-10-08

22206 / 2

Active Ingredient

SILODOSIN

Application Number

22206

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2008-10-08

Regulatory Status

Discontinued

2011
21 Jun
Discontinued Application: 21359

Drug Name

RECTIV

Product Number

1

Dosage Form

-

Strength

0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2011-06-21

21359 / 1

Active Ingredient

NITROGLYCERIN

Application Number

21359

Product Number

1

Dosage Form

-

Strength

0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2011-06-21

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 4125

Drug Name

SULFADIAZINE

Product Number

5

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

Active Ingredient

SULFADIAZINE

Application Number

4125

Product Number

5

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996
22 Oct
Discontinued Application: 20591

Drug Name

TARKA

Product Number

1

Dosage Form

-

Strength

2MG;180MG

Approval Date

1996-10-22

20591 / 1

Active Ingredient

TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

Application Number

20591

Product Number

1

Dosage Form

-

Strength

2MG;180MG

Approval Date

1996-10-22

Regulatory Status

Discontinued

1996
22 Oct
Discontinued Application: 20591

Drug Name

TARKA

Product Number

2

Dosage Form

-

Strength

4MG;240MG

Approval Date

1996-10-22

20591 / 2

Active Ingredient

TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

Application Number

20591

Product Number

2

Dosage Form

-

Strength

4MG;240MG

Approval Date

1996-10-22

Regulatory Status

Discontinued

1996
22 Oct
Discontinued Application: 20591

Drug Name

TARKA

Product Number

3

Dosage Form

-

Strength

1MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-10-22

20591 / 3

Active Ingredient

TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

Application Number

20591

Product Number

3

Dosage Form

-

Strength

1MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-10-22

Regulatory Status

Discontinued

1996
22 Oct
Discontinued Application: 20591

Drug Name

TARKA

Product Number

4

Dosage Form

-

Strength

2MG;240MG

Approval Date

1996-10-22

20591 / 4

Active Ingredient

TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

Application Number

20591

Product Number

4

Dosage Form

-

Strength

2MG;240MG

Approval Date

1996-10-22

Regulatory Status

Discontinued

2015
24 Jul
Discontinued Application: 207931

Drug Name

TECHNIVIE

Product Number

1

Dosage Form

-

Strength

12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2015-07-24

207931 / 1

Active Ingredient

OMBITASVIR; PARITAPREVIR; RITONAVIR

Application Number

207931

Product Number

1

Dosage Form

-

Strength

12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2015-07-24

Regulatory Status

Discontinued

1997
22 Dec
Discontinued Application: 20738

Drug Name

TEVETEN

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1997-12-22

20738 / 4

Active Ingredient

EPROSARTAN MESYLATE

Application Number

20738

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1997-12-22

Regulatory Status

Discontinued

1997
22 Dec
Discontinued Application: 20738

Drug Name

TEVETEN

Product Number

5

Dosage Form

-

Strength

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

Approval Date

1997-12-22

20738 / 5

Active Ingredient

EPROSARTAN MESYLATE

Application Number

20738

Product Number

5

Dosage Form

-

Strength

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

Approval Date

1997-12-22

Regulatory Status

Discontinued

1999
27 May
Discontinued Application: 20738

Drug Name

TEVETEN

Product Number

6

Dosage Form

-

Strength

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

Approval Date

1999-05-27

20738 / 6

Active Ingredient

EPROSARTAN MESYLATE

Application Number

20738

Product Number

6

Dosage Form

-

Strength

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

Approval Date

1999-05-27

Regulatory Status

Discontinued

2001
01 Nov
Discontinued Application: 21268

Drug Name

TEVETEN HCT

Product Number

1

Dosage Form

-

Strength

600MG;12.5MG

Approval Date

2001-11-01

21268 / 1

Active Ingredient

EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE

Application Number

21268

Product Number

1

Dosage Form

-

Strength

600MG;12.5MG

Approval Date

2001-11-01

Regulatory Status

Discontinued

2001
01 Nov
Discontinued Application: 21268

Drug Name

TEVETEN HCT

Product Number

2

Dosage Form

-

Strength

600MG;25MG

Approval Date

2001-11-01

21268 / 2

Active Ingredient

EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE

Application Number

21268

Product Number

2

Dosage Form

-

Strength

600MG;25MG

Approval Date

2001-11-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10599

Drug Name

TRAL

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

10599 / 1

Active Ingredient

HEXOCYCLIUM METHYLSULFATE

Application Number

10599

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2001
04 Sep
Discontinued Application: 21203

Drug Name

TRICOR

Product Number

1

Dosage Form

-

Strength

54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-09-04

21203 / 1

Active Ingredient

FENOFIBRATE

Application Number

21203

Product Number

1

Dosage Form

-

Strength

54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-09-04

Regulatory Status

Discontinued

2001
04 Sep
Discontinued Application: 21203

Drug Name

TRICOR

Product Number

3

Dosage Form

-

Strength

160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-09-04

21203 / 3

Active Ingredient

FENOFIBRATE

Application Number

21203

Product Number

3

Dosage Form

-

Strength

160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-09-04

Regulatory Status

Discontinued

2004
05 Nov
Discontinued Application: 21656

Drug Name

TRICOR

Product Number

1

Dosage Form

-

Strength

48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-11-05

21656 / 1

Active Ingredient

FENOFIBRATE

Application Number

21656

Product Number

1

Dosage Form

-

Strength

48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-11-05

Regulatory Status

Discontinued

2004
05 Nov
Discontinued Application: 21656

Drug Name

TRICOR

Product Number

2

Dosage Form

-

Strength

145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-11-05

21656 / 2

Active Ingredient

FENOFIBRATE

Application Number

21656

Product Number

2

Dosage Form

-

Strength

145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-11-05

Regulatory Status

Discontinued

1998
09 Feb
Discontinued Application: 19304

Drug Name

TRICOR (MICRONIZED)

Product Number

2

Dosage Form

-

Strength

67MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-02-09

19304 / 2

Active Ingredient

FENOFIBRATE

Application Number

19304

Product Number

2

Dosage Form

-

Strength

67MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-02-09

Regulatory Status

Discontinued

1999
30 Jun
Discontinued Application: 19304

Drug Name

TRICOR (MICRONIZED)

Product Number

3

Dosage Form

-

Strength

134MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-06-30

19304 / 3

Active Ingredient

FENOFIBRATE

Application Number

19304

Product Number

3

Dosage Form

-

Strength

134MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-06-30

Regulatory Status

Discontinued

1999
30 Jun
Discontinued Application: 19304

Drug Name

TRICOR (MICRONIZED)

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1999-06-30

19304 / 4

Active Ingredient

FENOFIBRATE

Application Number

19304

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1999-06-30

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 5856

Drug Name

TRIDIONE

Product Number

2

Dosage Form

-

Strength

200MG/5ML

Approval Date

1982-01-01

Active Ingredient

TRIMETHADIONE

Application Number

5856

Product Number

2

Dosage Form

-

Strength

200MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 5856

Drug Name

TRIDIONE

Product Number

5

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

Active Ingredient

TRIMETHADIONE

Application Number

5856

Product Number

5

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 5856

Drug Name

TRIDIONE

Product Number

9

Dosage Form

-

Strength

150MG

Approval Date

1982-01-01

Active Ingredient

TRIMETHADIONE

Application Number

5856

Product Number

9

Dosage Form

-

Strength

150MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2008
15 Dec
Discontinued Application: 22224

Drug Name

TRILIPIX

Product Number

1

Dosage Form

-

Strength

EQ 45MG FENOFIBRIC ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-12-15

22224 / 1

Active Ingredient

CHOLINE FENOFIBRATE

Application Number

22224

Product Number

1

Dosage Form

-

Strength

EQ 45MG FENOFIBRIC ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-12-15

Regulatory Status

Discontinued

2008
15 Dec
Discontinued Application: 22224

Drug Name

TRILIPIX

Product Number

2

Dosage Form

-

Strength

EQ 135MG FENOFIBRIC ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-12-15

22224 / 2

Active Ingredient

CHOLINE FENOFIBRATE

Application Number

22224

Product Number

2

Dosage Form

-

Strength

EQ 135MG FENOFIBRIC ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-12-15

Regulatory Status

Discontinued

1997
10 Dec
Discontinued Application: 20675

Drug Name

URSO 250

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1997-12-10

20675 / 1

Active Ingredient

URSODIOL

Application Number

20675

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1997-12-10

Regulatory Status

Discontinued

2004
21 Jul
Discontinued Application: 20675

Drug Name

URSO FORTE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2004-07-21

20675 / 2

Active Ingredient

URSODIOL

Application Number

20675

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2004-07-21

Regulatory Status

Discontinued

2000
27 Jul
Discontinued Application: 21145

Drug Name

VANIQA

Product Number

1

Dosage Form

-

Strength

13.9%

Approval Date

2000-07-27

21145 / 1

Active Ingredient

EFLORNITHINE HYDROCHLORIDE

Application Number

21145

Product Number

1

Dosage Form

-

Strength

13.9%

Approval Date

2000-07-27

Regulatory Status

Discontinued

1983
07 Jan
Discontinued Application: 88058

Drug Name

VICODIN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1983-01-07

88058 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

88058

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1983-01-07

Regulatory Status

Discontinued

1988
09 Dec
Discontinued Application: 89736

Drug Name

VICODIN ES

Product Number

1

Dosage Form

-

Strength

750MG;7.5MG

Approval Date

1988-12-09

89736 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

89736

Product Number

1

Dosage Form

-

Strength

750MG;7.5MG

Approval Date

1988-12-09

Regulatory Status

Discontinued

1996
23 Sep
Discontinued Application: 40117

Drug Name

VICODIN HP

Product Number

1

Dosage Form

-

Strength

660MG;10MG

Approval Date

1996-09-23

40117 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40117

Product Number

1

Dosage Form

-

Strength

660MG;10MG

Approval Date

1996-09-23

Regulatory Status

Discontinued

1997
23 Sep
Discontinued Application: 20716

Drug Name

VICOPROFEN

Product Number

1

Dosage Form

-

Strength

7.5MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-09-23

20716 / 1

Active Ingredient

HYDROCODONE BITARTRATE; IBUPROFEN

Application Number

20716

Product Number

1

Dosage Form

-

Strength

7.5MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-09-23

Regulatory Status

Discontinued

2014
19 Dec
Discontinued Application: 206619

Drug Name

VIEKIRA PAK (COPACKAGED)

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE;12.5MG, 75MG, 50MG

Approval Date

2014-12-19

206619 / 1

Active Ingredient

DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR

Application Number

206619

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE;12.5MG, 75MG, 50MG

Approval Date

2014-12-19

Regulatory Status

Discontinued

2016
22 Jul
Discontinued Application: 208624

Drug Name

VIEKIRA XR

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2016-07-22

208624 / 1

Active Ingredient

DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

Application Number

208624

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2016-07-22

Regulatory Status

Discontinued

2021
28 Oct
Discontinued Application: 214028

Drug Name

VUITY

Product Number

1

Dosage Form

-

Strength

1.25%

Approval Date

2021-10-28

214028 / 1

Active Ingredient

PILOCARPINE HYDROCHLORIDE

Application Number

214028

Product Number

1

Dosage Form

-

Strength

1.25%

Approval Date

2021-10-28

Regulatory Status

Discontinued

2005
26 May
Discontinued Application: 21606

Drug Name

ZEMPLAR

Product Number

1

Dosage Form

-

Strength

1MCG

Approval Date

2005-05-26

21606 / 1

Active Ingredient

PARICALCITOL

Application Number

21606

Product Number

1

Dosage Form

-

Strength

1MCG

Approval Date

2005-05-26

Regulatory Status

Discontinued

2005
26 May
Discontinued Application: 21606

Drug Name

ZEMPLAR

Product Number

2

Dosage Form

-

Strength

2MCG

Approval Date

2005-05-26

21606 / 2

Active Ingredient

PARICALCITOL

Application Number

21606

Product Number

2

Dosage Form

-

Strength

2MCG

Approval Date

2005-05-26

Regulatory Status

Discontinued

2005
26 May
Discontinued Application: 21606

Drug Name

ZEMPLAR

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2005-05-26

21606 / 3

Active Ingredient

PARICALCITOL

Application Number

21606

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2005-05-26

Regulatory Status

Discontinued

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Drug Status Breakdown
158 total
  • Discontinued
Official Source

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

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Drug Name

ACYCLOVIR

Application Number

75114

Product Number

1

Active Ingredient

ACYCLOVIR SODIUM

Dosage Form

-

Strength

EQ 50MG BASE/ML

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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