Novartis Pharmaceuticals Corporation Discontinued
FDA Approved Drugs

Novartis Pharmaceuticals Corporation 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 217
  • Latest Approval Date Oct 29, 2015
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
369
View
Unclassified
31
View
Discontinued
217
View
RX
121
View
Company Overview

Company

Novartis Pharmaceuticals Corporation Discontinued

Country

Switzerland

Email

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Company Snapshot

Novartis Pharmaceuticals Corporation Discontinued

Klybeckstrasse 141, CH-4057, Basel

Switzerland

www.novartis.com/ View on Map
FDA Approved Drug Records ( 217 records )
1982
01 Jan
Discontinued Application: 9436

Drug Name

ACYLANID

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

Active Ingredient

ACETYLDIGITOXIN

Application Number

9436

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1993
23 Sep
Discontinued Application: 20191

Drug Name

ALOMIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1993-09-23

20191 / 1

Active Ingredient

LODOXAMIDE TROMETHAMINE

Application Number

20191

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1993-09-23

Regulatory Status

Discontinued

2010
21 Dec
Discontinued Application: 200045

Drug Name

AMTURNIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE;EQ 5MG BASE;12.5MG

Approval Date

2010-12-21

200045 / 1

Active Ingredient

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

Application Number

200045

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE;EQ 5MG BASE;12.5MG

Approval Date

2010-12-21

Regulatory Status

Discontinued

2010
21 Dec
Discontinued Application: 200045

Drug Name

AMTURNIDE

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE;EQ 5MG BASE;12.5MG

Approval Date

2010-12-21

200045 / 2

Active Ingredient

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

Application Number

200045

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE;EQ 5MG BASE;12.5MG

Approval Date

2010-12-21

Regulatory Status

Discontinued

2010
21 Dec
Discontinued Application: 200045

Drug Name

AMTURNIDE

Product Number

3

Dosage Form

-

Strength

EQ 300MG BASE;EQ 5MG BASE;25MG

Approval Date

2010-12-21

200045 / 3

Active Ingredient

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

Application Number

200045

Product Number

3

Dosage Form

-

Strength

EQ 300MG BASE;EQ 5MG BASE;25MG

Approval Date

2010-12-21

Regulatory Status

Discontinued

2010
21 Dec
Discontinued Application: 200045

Drug Name

AMTURNIDE

Product Number

4

Dosage Form

-

Strength

EQ 300MG BASE;EQ 10MG BASE;12.5MG

Approval Date

2010-12-21

200045 / 4

Active Ingredient

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

Application Number

200045

Product Number

4

Dosage Form

-

Strength

EQ 300MG BASE;EQ 10MG BASE;12.5MG

Approval Date

2010-12-21

Regulatory Status

Discontinued

2010
21 Dec
Discontinued Application: 200045

Drug Name

AMTURNIDE

Product Number

5

Dosage Form

-

Strength

EQ 300MG BASE;EQ 10MG BASE;25MG

Approval Date

2010-12-21

200045 / 5

Active Ingredient

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

Application Number

200045

Product Number

5

Dosage Form

-

Strength

EQ 300MG BASE;EQ 10MG BASE;25MG

Approval Date

2010-12-21

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8492

Drug Name

ANTRENYL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Active Ingredient

OXYPHENONIUM BROMIDE

Application Number

8492

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11556

Drug Name

ANTURANE

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11556 / 3

Active Ingredient

SULFINPYRAZONE

Application Number

11556

Product Number

3

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: 11556

Drug Name

ANTURANE

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11556 / 4

Active Ingredient

SULFINPYRAZONE

Application Number

11556

Product Number

4

Dosage Form

-

Strength

200MG **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: 84735

Drug Name

APRESAZIDE

Product Number

1

Dosage Form

-

Strength

25MG;25MG

Approval Date

1982-01-01

84735 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

84735

Product Number

1

Dosage Form

-

Strength

25MG;25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84810

Drug Name

APRESAZIDE

Product Number

1

Dosage Form

-

Strength

50MG;50MG

Approval Date

1982-01-01

84810 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

84810

Product Number

1

Dosage Form

-

Strength

50MG;50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84811

Drug Name

APRESAZIDE

Product Number

1

Dosage Form

-

Strength

100MG;50MG

Approval Date

1982-01-01

84811 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

84811

Product Number

1

Dosage Form

-

Strength

100MG;50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8303

Drug Name

APRESOLINE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

8303

Product Number

1

Dosage Form

-

Strength

25MG **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: 8303

Drug Name

APRESOLINE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

8303

Product Number

2

Dosage Form

-

Strength

50MG **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: 8303

Drug Name

APRESOLINE

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

8303

Product Number

3

Dosage Form

-

Strength

20MG/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: 8303

Drug Name

APRESOLINE

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

8303

Product Number

4

Dosage Form

-

Strength

10MG **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: 8303

Drug Name

APRESOLINE

Product Number

5

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

8303

Product Number

5

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: 12026

Drug Name

APRESOLINE-ESIDRIX

Product Number

2

Dosage Form

-

Strength

25MG;15MG

Approval Date

1982-01-01

12026 / 2

Active Ingredient

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

12026

Product Number

2

Dosage Form

-

Strength

25MG;15MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2011
01 Jul
Discontinued Application: 22383

Drug Name

ARCAPTA NEOHALER

Product Number

1

Dosage Form

-

Strength

EQ 75MCG BASE

Approval Date

2011-07-01

22383 / 1

Active Ingredient

INDACATEROL MALEATE

Application Number

22383

Product Number

1

Dosage Form

-

Strength

EQ 75MCG BASE

Approval Date

2011-07-01

Regulatory Status

Discontinued

1991
31 Oct
Discontinued Application: 20036

Drug Name

AREDIA

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1991-10-31

20036 / 1

Active Ingredient

PAMIDRONATE DISODIUM

Application Number

20036

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1991-10-31

Regulatory Status

Discontinued

1993
06 May
Discontinued Application: 20036

Drug Name

AREDIA

Product Number

3

Dosage Form

-

Strength

60MG/VIAL

Approval Date

1993-05-06

20036 / 3

Active Ingredient

PAMIDRONATE DISODIUM

Application Number

20036

Product Number

3

Dosage Form

-

Strength

60MG/VIAL

Approval Date

1993-05-06

Regulatory Status

Discontinued

1993
06 May
Discontinued Application: 20036

Drug Name

AREDIA

Product Number

4

Dosage Form

-

Strength

90MG/VIAL

Approval Date

1993-05-06

20036 / 4

Active Ingredient

PAMIDRONATE DISODIUM

Application Number

20036

Product Number

4

Dosage Form

-

Strength

90MG/VIAL

Approval Date

1993-05-06

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85148

Drug Name

ASBRON

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1982-01-01

85148 / 1

Active Ingredient

THEOPHYLLINE SODIUM GLYCINATE

Application Number

85148

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
17 Aug
Discontinued Application: 18762

Drug Name

BRETHAIRE

Product Number

1

Dosage Form

-

Strength

0.2MG/INH

Approval Date

1984-08-17

18762 / 1

Active Ingredient

TERBUTALINE SULFATE

Application Number

18762

Product Number

1

Dosage Form

-

Strength

0.2MG/INH

Approval Date

1984-08-17

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8319

Drug Name

BUTAZOLIDIN

Product Number

8

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Active Ingredient

PHENYLBUTAZONE

Application Number

8319

Product Number

8

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8319

Drug Name

BUTAZOLIDIN

Product Number

9

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Active Ingredient

PHENYLBUTAZONE

Application Number

8319

Product Number

9

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 6620

Drug Name

CAFERGOT

Product Number

1

Dosage Form

-

Strength

100MG;1MG

Approval Date

1982-01-01

Active Ingredient

CAFFEINE; ERGOTAMINE TARTRATE

Application Number

6620

Product Number

1

Dosage Form

-

Strength

100MG;1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9000

Drug Name

CAFERGOT

Product Number

2

Dosage Form

-

Strength

100MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Active Ingredient

CAFFEINE; ERGOTAMINE TARTRATE

Application Number

9000

Product Number

2

Dosage Form

-

Strength

100MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1995
28 Apr
Discontinued Application: 73677

Drug Name

CARBASTAT

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1995-04-28

73677 / 1

Active Ingredient

CARBACHOL

Application Number

73677

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1995-04-28

Regulatory Status

Discontinued

1993
24 Nov
Discontinued Application: 20142

Drug Name

CATAFLAM

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1993-11-24

20142 / 1

Active Ingredient

DICLOFENAC POTASSIUM

Application Number

20142

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1993-11-24

Regulatory Status

Discontinued

1993
24 Nov
Discontinued Application: 20142

Drug Name

CATAFLAM

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1993-11-24

20142 / 2

Active Ingredient

DICLOFENAC POTASSIUM

Application Number

20142

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1993-11-24

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9282

Drug Name

CEDILANID-D

Product Number

2

Dosage Form

-

Strength

0.2MG/ML

Approval Date

1982-01-01

Active Ingredient

DESLANOSIDE

Application Number

9282

Product Number

2

Dosage Form

-

Strength

0.2MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1986
31 Oct
Discontinued Application: 18470

Drug Name

CIBACALCIN

Product Number

1

Dosage Form

-

Strength

0.5MG/VIAL

Approval Date

1986-10-31

18470 / 1

Active Ingredient

CALCITONIN HUMAN

Application Number

18470

Product Number

1

Dosage Form

-

Strength

0.5MG/VIAL

Approval Date

1986-10-31

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18202

Drug Name

CYTADREN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

18202 / 1

Active Ingredient

AMINOGLUTETHIMIDE

Application Number

18202

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
29 Oct
Discontinued Application: 62544

Drug Name

DEXACIDIN

Product Number

1

Dosage Form

-

Strength

0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1984-10-29

62544 / 1

Active Ingredient

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

62544

Product Number

1

Dosage Form

-

Strength

0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1984-10-29

Regulatory Status

Discontinued

1985
22 Feb
Discontinued Application: 62566

Drug Name

DEXACIDIN

Product Number

1

Dosage Form

-

Strength

0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Approval Date

1985-02-22

62566 / 1

Active Ingredient

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

62566

Product Number

1

Dosage Form

-

Strength

0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Approval Date

1985-02-22

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16755

Drug Name

DIAPID

Product Number

1

Dosage Form

-

Strength

0.185MG/ML

Approval Date

1982-01-01

16755 / 1

Active Ingredient

LYPRESSIN

Application Number

16755

Product Number

1

Dosage Form

-

Strength

0.185MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996
23 Dec
Discontinued Application: 20665

Drug Name

DIOVAN

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1996-12-23

20665 / 1

Active Ingredient

VALSARTAN

Application Number

20665

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1996-12-23

Regulatory Status

Discontinued

1996
23 Dec
Discontinued Application: 20665

Drug Name

DIOVAN

Product Number

2

Dosage Form

-

Strength

160MG

Approval Date

1996-12-23

20665 / 2

Active Ingredient

VALSARTAN

Application Number

20665

Product Number

2

Dosage Form

-

Strength

160MG

Approval Date

1996-12-23

Regulatory Status

Discontinued

1997
29 Dec
Discontinued Application: 20706

Drug Name

EMADINE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1997-12-29

20706 / 1

Active Ingredient

EMEDASTINE DIFUMARATE

Application Number

20706

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1997-12-29

Regulatory Status

Discontinued

1984
30 Nov
Discontinued Application: 18885

Drug Name

EMBOLEX

Product Number

1

Dosage Form

-

Strength

0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5ML

Approval Date

1984-11-30

18885 / 1

Active Ingredient

DIHYDROERGOTAMINE MESYLATE; HEPARIN SODIUM; LIDOCAINE HYDROCHLORIDE

Application Number

18885

Product Number

1

Dosage Form

-

Strength

0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5ML

Approval Date

1984-11-30

Regulatory Status

Discontinued

1984
30 Nov
Discontinued Application: 18885

Drug Name

EMBOLEX

Product Number

2

Dosage Form

-

Strength

0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7ML

Approval Date

1984-11-30

18885 / 2

Active Ingredient

DIHYDROERGOTAMINE MESYLATE; HEPARIN SODIUM; LIDOCAINE HYDROCHLORIDE

Application Number

18885

Product Number

2

Dosage Form

-

Strength

0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7ML

Approval Date

1984-11-30

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11793

Drug Name

ESIDRIX

Product Number

5

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

11793 / 5

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

11793

Product Number

5

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11793

Drug Name

ESIDRIX

Product Number

8

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

11793 / 8

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

11793

Product Number

8

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11793

Drug Name

ESIDRIX

Product Number

9

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

11793 / 9

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

11793

Product Number

9

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 13553

Drug Name

ESIMIL

Product Number

1

Dosage Form

-

Strength

10MG;25MG

Approval Date

1982-01-01

13553 / 1

Active Ingredient

GUANETHIDINE MONOSULFATE; HYDROCHLOROTHIAZIDE

Application Number

13553

Product Number

1

Dosage Form

-

Strength

10MG;25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1986
10 Sep
Discontinued Application: 19081

Drug Name

ESTRADERM

Product Number

2

Dosage Form

-

Strength

0.05MG/24HR

Approval Date

1986-09-10

19081 / 2

Active Ingredient

ESTRADIOL

Application Number

19081

Product Number

2

Dosage Form

-

Strength

0.05MG/24HR

Approval Date

1986-09-10

Regulatory Status

Discontinued

1986
10 Sep
Discontinued Application: 19081

Drug Name

ESTRADERM

Product Number

3

Dosage Form

-

Strength

0.1MG/24HR

Approval Date

1986-09-10

19081 / 3

Active Ingredient

ESTRADIOL

Application Number

19081

Product Number

3

Dosage Form

-

Strength

0.1MG/24HR

Approval Date

1986-09-10

Regulatory Status

Discontinued

2000
21 Apr
Discontinued Application: 20823

Drug Name

EXELON

Product Number

3

Dosage Form

-

Strength

EQ 1.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-04-21

20823 / 3

Active Ingredient

RIVASTIGMINE TARTRATE

Application Number

20823

Product Number

3

Dosage Form

-

Strength

EQ 1.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-04-21

Regulatory Status

Discontinued

2000
21 Apr
Discontinued Application: 20823

Drug Name

EXELON

Product Number

4

Dosage Form

-

Strength

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

Approval Date

2000-04-21

20823 / 4

Active Ingredient

RIVASTIGMINE TARTRATE

Application Number

20823

Product Number

4

Dosage Form

-

Strength

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

Approval Date

2000-04-21

Regulatory Status

Discontinued

2000
21 Apr
Discontinued Application: 20823

Drug Name

EXELON

Product Number

5

Dosage Form

-

Strength

EQ 4.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-04-21

20823 / 5

Active Ingredient

RIVASTIGMINE TARTRATE

Application Number

20823

Product Number

5

Dosage Form

-

Strength

EQ 4.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-04-21

Regulatory Status

Discontinued

2000
21 Apr
Discontinued Application: 20823

Drug Name

EXELON

Product Number

6

Dosage Form

-

Strength

EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-04-21

20823 / 6

Active Ingredient

RIVASTIGMINE TARTRATE

Application Number

20823

Product Number

6

Dosage Form

-

Strength

EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-04-21

Regulatory Status

Discontinued

2000
21 Apr
Discontinued Application: 21025

Drug Name

EXELON

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2000-04-21

21025 / 1

Active Ingredient

RIVASTIGMINE TARTRATE

Application Number

21025

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2000-04-21

Regulatory Status

Discontinued

1996
26 Apr
Discontinued Application: 20363

Drug Name

FAMVIR

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1996-04-26

20363 / 1

Active Ingredient

FAMCICLOVIR

Application Number

20363

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1996-04-26

Regulatory Status

Discontinued

1994
29 Jun
Discontinued Application: 20363

Drug Name

FAMVIR

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1994-06-29

20363 / 2

Active Ingredient

FAMCICLOVIR

Application Number

20363

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1994-06-29

Regulatory Status

Discontinued

1995
11 Dec
Discontinued Application: 20363

Drug Name

FAMVIR

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1995-12-11

20363 / 3

Active Ingredient

FAMCICLOVIR

Application Number

20363

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1995-12-11

Regulatory Status

Discontinued

1986
27 Feb
Discontinued Application: 70185

Drug Name

FLUOR-OP

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1986-02-27

70185 / 1

Active Ingredient

FLUOROMETHOLONE

Application Number

70185

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1986-02-27

Regulatory Status

Discontinued

1989
28 Jun
Discontinued Application: 72687

Drug Name

FOAMICON

Product Number

1

Dosage Form

-

Strength

80MG;20MG

Approval Date

1989-06-28

72687 / 1

Active Ingredient

ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE

Application Number

72687

Product Number

1

Dosage Form

-

Strength

80MG;20MG

Approval Date

1989-06-28

Regulatory Status

Discontinued

2001
16 Feb
Discontinued Application: 20831

Drug Name

FORADIL

Product Number

1

Dosage Form

-

Strength

0.012MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-02-16

20831 / 1

Active Ingredient

FORMOTEROL FUMARATE

Application Number

20831

Product Number

1

Dosage Form

-

Strength

0.012MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-02-16

Regulatory Status

Discontinued

2006
15 Dec
Discontinued Application: 21592

Drug Name

FORADIL CERTIHALER

Product Number

1

Dosage Form

-

Strength

0.0085MG/INH

Approval Date

2006-12-15

21592 / 1

Active Ingredient

FORMOTEROL FUMARATE

Application Number

21592

Product Number

1

Dosage Form

-

Strength

0.0085MG/INH

Approval Date

2006-12-15

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17869

Drug Name

FUNDUSCEIN-25

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

17869 / 1

Active Ingredient

FLUORESCEIN SODIUM

Application Number

17869

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
30 Mar
Discontinued Application: 62480

Drug Name

GENTACIDIN

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

1984-03-30

62480 / 1

Active Ingredient

GENTAMICIN SULFATE

Application Number

62480

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

1984-03-30

Regulatory Status

Discontinued

1984
26 Jul
Discontinued Application: 62501

Drug Name

GENTACIDIN

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

1984-07-26

62501 / 1

Active Ingredient

GENTAMICIN SULFATE

Application Number

62501

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

1984-07-26

Regulatory Status

Discontinued

2001
10 May
Discontinued Application: 21335

Drug Name

GLEEVEC

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2001-05-10

21335 / 1

Active Ingredient

IMATINIB MESYLATE

Application Number

21335

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2001-05-10

Regulatory Status

Discontinued

2001
10 May
Discontinued Application: 21335

Drug Name

GLEEVEC

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2001-05-10

21335 / 2

Active Ingredient

IMATINIB MESYLATE

Application Number

21335

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2001-05-10

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 6203

Drug Name

HEAVY SOLUTION NUPERCAINE

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1982-01-01

Active Ingredient

DIBUCAINE HYDROCHLORIDE

Application Number

6203

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9087

Drug Name

HYDERGINE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Active Ingredient

ERGOLOID MESYLATES

Application Number

9087

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9087

Drug Name

HYDERGINE

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1982-01-01

Active Ingredient

ERGOLOID MESYLATES

Application Number

9087

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17993

Drug Name

HYDERGINE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

17993 / 1

Active Ingredient

ERGOLOID MESYLATES

Application Number

17993

Product Number

1

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: 17993

Drug Name

HYDERGINE

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

17993 / 3

Active Ingredient

ERGOLOID MESYLATES

Application Number

17993

Product Number

3

Dosage Form

-

Strength

0.5MG **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: 18418

Drug Name

HYDERGINE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1982-01-01

18418 / 1

Active Ingredient

ERGOLOID MESYLATES

Application Number

18418

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1983
18 Jan
Discontinued Application: 18706

Drug Name

HYDERGINE LC

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1983-01-18

18706 / 1

Active Ingredient

ERGOLOID MESYLATES

Application Number

18706

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1983-01-18

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86765

Drug Name

IMIPRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

86765 / 1

Active Ingredient

IMIPRAMINE HYDROCHLORIDE

Application Number

86765

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80751

Drug Name

INFLAMASE FORTE

Product Number

2

Dosage Form

-

Strength

EQ 0.9% PHOSPHATE

Approval Date

1982-01-01

80751 / 2

Active Ingredient

PREDNISOLONE SODIUM PHOSPHATE

Application Number

80751

Product Number

2

Dosage Form

-

Strength

EQ 0.9% PHOSPHATE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80751

Drug Name

INFLAMASE MILD

Product Number

1

Dosage Form

-

Strength

EQ 0.11% PHOSPHATE

Approval Date

1982-01-01

80751 / 1

Active Ingredient

PREDNISOLONE SODIUM PHOSPHATE

Application Number

80751

Product Number

1

Dosage Form

-

Strength

EQ 0.11% PHOSPHATE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80935

Drug Name

INH

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

80935 / 1

Active Ingredient

ISONIAZID

Application Number

80935

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12329

Drug Name

ISMELIN

Product Number

1

Dosage Form

-

Strength

EQ 10MG SULFATE

Approval Date

1982-01-01

12329 / 1

Active Ingredient

GUANETHIDINE MONOSULFATE

Application Number

12329

Product Number

1

Dosage Form

-

Strength

EQ 10MG SULFATE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12329

Drug Name

ISMELIN

Product Number

2

Dosage Form

-

Strength

EQ 25MG SULFATE

Approval Date

1982-01-01

12329 / 2

Active Ingredient

GUANETHIDINE MONOSULFATE

Application Number

12329

Product Number

2

Dosage Form

-

Strength

EQ 25MG SULFATE

Approval Date

1982-01-01

Regulatory Status

Discontinued

2014
15 May
Discontinued Application: 204822

Drug Name

IZBA

Product Number

1

Dosage Form

-

Strength

0.003% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2014-05-15

204822 / 1

Active Ingredient

TRAVOPROST

Application Number

204822

Product Number

1

Dosage Form

-

Strength

0.003% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2014-05-15

Regulatory Status

Discontinued

1992
30 Dec
Discontinued Application: 20192

Drug Name

LAMISIL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1992-12-30

20192 / 1

Active Ingredient

TERBINAFINE HYDROCHLORIDE

Application Number

20192

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1992-12-30

Regulatory Status

Discontinued

1996
10 May
Discontinued Application: 20539

Drug Name

LAMISIL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1996-05-10

20539 / 1

Active Ingredient

TERBINAFINE HYDROCHLORIDE

Application Number

20539

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1996-05-10

Regulatory Status

Discontinued

2007
28 Sep
Discontinued Application: 22071

Drug Name

LAMISIL

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/PACKET

Approval Date

2007-09-28

22071 / 1

Active Ingredient

TERBINAFINE HYDROCHLORIDE

Application Number

22071

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/PACKET

Approval Date

2007-09-28

Regulatory Status

Discontinued

2007
28 Sep
Discontinued Application: 22071

Drug Name

LAMISIL

Product Number

2

Dosage Form

-

Strength

EQ 187.5MG BASE/PACKET

Approval Date

2007-09-28

22071 / 2

Active Ingredient

TERBINAFINE HYDROCHLORIDE

Application Number

22071

Product Number

2

Dosage Form

-

Strength

EQ 187.5MG BASE/PACKET

Approval Date

2007-09-28

Regulatory Status

Discontinued

1986
15 Dec
Discontinued Application: 19500

Drug Name

LAMPRENE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1986-12-15

19500 / 1

Active Ingredient

CLOFAZIMINE

Application Number

19500

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1986-12-15

Regulatory Status

Discontinued

1986
15 Dec
Discontinued Application: 19500

Drug Name

LAMPRENE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1986-12-15

19500 / 2

Active Ingredient

CLOFAZIMINE

Application Number

19500

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1986-12-15

Regulatory Status

Discontinued

1993
31 Dec
Discontinued Application: 20261

Drug Name

LESCOL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1993-12-31

20261 / 1

Active Ingredient

FLUVASTATIN SODIUM

Application Number

20261

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1993-12-31

Regulatory Status

Discontinued

1993
31 Dec
Discontinued Application: 20261

Drug Name

LESCOL

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1993-12-31

20261 / 2

Active Ingredient

FLUVASTATIN SODIUM

Application Number

20261

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1993-12-31

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17851

Drug Name

LIORESAL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

17851 / 1

Active Ingredient

BACLOFEN

Application Number

17851

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
20 Jan
Discontinued Application: 17851

Drug Name

LIORESAL

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-20

17851 / 3

Active Ingredient

BACLOFEN

Application Number

17851

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-20

Regulatory Status

Discontinued

1993
10 Nov
Discontinued Application: 20219

Drug Name

LIVOSTIN

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1993-11-10

20219 / 1

Active Ingredient

LEVOCABASTINE HYDROCHLORIDE

Application Number

20219

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1993-11-10

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16379

Drug Name

LOCORTEN

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

1982-01-01

16379 / 1

Active Ingredient

FLUMETHASONE PIVALATE

Application Number

16379

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1987
31 Dec
Discontinued Application: 19451

Drug Name

LOPRESSIDONE

Product Number

1

Dosage Form

-

Strength

25MG;100MG

Approval Date

1987-12-31

19451 / 1

Active Ingredient

CHLORTHALIDONE; METOPROLOL TARTRATE

Application Number

19451

Product Number

1

Dosage Form

-

Strength

25MG;100MG

Approval Date

1987-12-31

Regulatory Status

Discontinued

1987
31 Dec
Discontinued Application: 19451

Drug Name

LOPRESSIDONE

Product Number

2

Dosage Form

-

Strength

25MG;200MG

Approval Date

1987-12-31

19451 / 2

Active Ingredient

CHLORTHALIDONE; METOPROLOL TARTRATE

Application Number

19451

Product Number

2

Dosage Form

-

Strength

25MG;200MG

Approval Date

1987-12-31

Regulatory Status

Discontinued

1984
30 Mar
Discontinued Application: 18704

Drug Name

LOPRESSOR

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1984-03-30

18704 / 1

Active Ingredient

METOPROLOL TARTRATE

Application Number

18704

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1984-03-30

Regulatory Status

Discontinued

1989
27 Dec
Discontinued Application: 19786

Drug Name

LOPRESSOR

Product Number

1

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

1989-12-27

19786 / 1

Active Ingredient

METOPROLOL FUMARATE

Application Number

19786

Product Number

1

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

1989-12-27

Regulatory Status

Discontinued

1989
27 Dec
Discontinued Application: 19786

Drug Name

LOPRESSOR

Product Number

2

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

1989-12-27

19786 / 2

Active Ingredient

METOPROLOL FUMARATE

Application Number

19786

Product Number

2

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

1989-12-27

Regulatory Status

Discontinued

1989
27 Dec
Discontinued Application: 19786

Drug Name

LOPRESSOR

Product Number

3

Dosage Form

-

Strength

EQ 300MG TARTRATE

Approval Date

1989-12-27

19786 / 3

Active Ingredient

METOPROLOL FUMARATE

Application Number

19786

Product Number

3

Dosage Form

-

Strength

EQ 300MG TARTRATE

Approval Date

1989-12-27

Regulatory Status

Discontinued

1989
27 Dec
Discontinued Application: 19786

Drug Name

LOPRESSOR

Product Number

4

Dosage Form

-

Strength

EQ 400MG TARTRATE

Approval Date

1989-12-27

19786 / 4

Active Ingredient

METOPROLOL FUMARATE

Application Number

19786

Product Number

4

Dosage Form

-

Strength

EQ 400MG TARTRATE

Approval Date

1989-12-27

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17543

Drug Name

LUDIOMIL

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

17543 / 1

Active Ingredient

MAPROTILINE HYDROCHLORIDE

Application Number

17543

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17543

Drug Name

LUDIOMIL

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

17543 / 2

Active Ingredient

MAPROTILINE HYDROCHLORIDE

Application Number

17543

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
30 Sep
Discontinued Application: 17543

Drug Name

LUDIOMIL

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1982-09-30

17543 / 3

Active Ingredient

MAPROTILINE HYDROCHLORIDE

Application Number

17543

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1982-09-30

Regulatory Status

Discontinued

2013
29 May
Discontinued Application: 204114

Drug Name

MEKINIST

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2013-05-29

204114 / 2

Active Ingredient

TRAMETINIB DIMETHYL SULFOXIDE

Application Number

204114

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2013-05-29

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11808

Drug Name

MELLARIL

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11808 / 3

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

11808

Product Number

3

Dosage Form

-

Strength

10MG **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: 11808

Drug Name

MELLARIL

Product Number

6

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11808 / 6

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

11808

Product Number

6

Dosage Form

-

Strength

25MG **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: 11808

Drug Name

MELLARIL

Product Number

9

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11808 / 9

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

11808

Product Number

9

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: 11808

Drug Name

MELLARIL

Product Number

11

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11808 / 11

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

11808

Product Number

11

Dosage Form

-

Strength

50MG **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: 11808

Drug Name

MELLARIL

Product Number

12

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11808 / 12

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

11808

Product Number

12

Dosage Form

-

Strength

30MG/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: 11808

Drug Name

MELLARIL

Product Number

15

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11808 / 15

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

11808

Product Number

15

Dosage Form

-

Strength

200MG **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: 11808

Drug Name

MELLARIL

Product Number

16

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11808 / 16

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

11808

Product Number

16

Dosage Form

-

Strength

15MG **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: 11808

Drug Name

MELLARIL

Product Number

17

Dosage Form

-

Strength

150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

11808 / 17

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

11808

Product Number

17

Dosage Form

-

Strength

150MG **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: 11808

Drug Name

MELLARIL

Product Number

18

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11808 / 18

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

11808

Product Number

18

Dosage Form

-

Strength

100MG/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: 17923

Drug Name

MELLARIL-S

Product Number

1

Dosage Form

-

Strength

EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17923 / 1

Active Ingredient

THIORIDAZINE

Application Number

17923

Product Number

1

Dosage Form

-

Strength

EQ 25MG HYDROCHLORIDE/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: 17923

Drug Name

MELLARIL-S

Product Number

2

Dosage Form

-

Strength

EQ 100MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17923 / 2

Active Ingredient

THIORIDAZINE

Application Number

17923

Product Number

2

Dosage Form

-

Strength

EQ 100MG HYDROCHLORIDE/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: 6008

Drug Name

MESANTOIN

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

Active Ingredient

MEPHENYTOIN

Application Number

6008

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: 3240

Drug Name

METANDREN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Active Ingredient

METHYLTESTOSTERONE

Application Number

3240

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 3240

Drug Name

METANDREN

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Active Ingredient

METHYLTESTOSTERONE

Application Number

3240

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 3240

Drug Name

METANDREN

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Active Ingredient

METHYLTESTOSTERONE

Application Number

3240

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 3240

Drug Name

METANDREN

Product Number

5

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Active Ingredient

METHYLTESTOSTERONE

Application Number

3240

Product Number

5

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16211

Drug Name

MIOCHOL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

16211 / 1

Active Ingredient

ACETYLCHOLINE CHLORIDE

Application Number

16211

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1995
14 Jul
Discontinued Application: 50715

Drug Name

NEORAL

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1995-07-14

50715 / 3

Active Ingredient

CYCLOSPORINE

Application Number

50715

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1995-07-14

Regulatory Status

Discontinued

2009
25 Nov
Discontinued Application: 22470

Drug Name

NEXCEDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2009-11-25

22470 / 1

Active Ingredient

KETOPROFEN

Application Number

22470

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2009-11-25

Regulatory Status

Discontinued

1990
23 May
Discontinued Application: 19972

Drug Name

OCUPRESS

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1990-05-23

19972 / 1

Active Ingredient

CARTEOLOL HYDROCHLORIDE

Application Number

19972

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1990-05-23

Regulatory Status

Discontinued

2008
15 Apr
Discontinued Application: 21861

Drug Name

PATANASE

Product Number

1

Dosage Form

-

Strength

0.665MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-04-15

21861 / 1

Active Ingredient

OLOPATADINE HYDROCHLORIDE

Application Number

21861

Product Number

1

Dosage Form

-

Strength

0.665MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-04-15

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 5914

Drug Name

PBZ

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Active Ingredient

TRIPELENNAMINE HYDROCHLORIDE

Application Number

5914

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 5914

Drug Name

PBZ

Product Number

4

Dosage Form

-

Strength

EQ 25MG HYDROCHLORIDE/5ML

Approval Date

1982-01-01

Active Ingredient

TRIPELENNAMINE CITRATE

Application Number

5914

Product Number

4

Dosage Form

-

Strength

EQ 25MG HYDROCHLORIDE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83149

Drug Name

PBZ

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

83149 / 1

Active Ingredient

TRIPELENNAMINE HYDROCHLORIDE

Application Number

83149

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10533

Drug Name

PBZ-SR

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

10533 / 1

Active Ingredient

TRIPELENNAMINE HYDROCHLORIDE

Application Number

10533

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10533

Drug Name

PBZ-SR

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

10533 / 2

Active Ingredient

TRIPELENNAMINE HYDROCHLORIDE

Application Number

10533

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 5151

Drug Name

PERCORTEN

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1982-01-01

Active Ingredient

DESOXYCORTICOSTERONE ACETATE

Application Number

5151

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8822

Drug Name

PERCORTEN

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

Active Ingredient

DESOXYCORTICOSTERONE PIVALATE

Application Number

8822

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985
22 Feb
Discontinued Application: 6403

Drug Name

PRISCOLINE

Product Number

5

Dosage Form

-

Strength

25MG/ML

Approval Date

1985-02-22

Active Ingredient

TOLAZOLINE HYDROCHLORIDE

Application Number

6403

Product Number

5

Dosage Form

-

Strength

25MG/ML

Approval Date

1985-02-22

Regulatory Status

Discontinued

2012
16 Nov
Discontinued Application: 22291

Drug Name

PROMACTA

Product Number

5

Dosage Form

-

Strength

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

Approval Date

2012-11-16

22291 / 5

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

22291

Product Number

5

Dosage Form

-

Strength

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

Approval Date

2012-11-16

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9215

Drug Name

RAUTENSIN

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

Active Ingredient

ALSEROXYLON

Application Number

9215

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8278

Drug Name

REGITINE

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Active Ingredient

PHENTOLAMINE MESYLATE

Application Number

8278

Product Number

3

Dosage Form

-

Strength

5MG/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
30 Mar
Discontinued Application: 18029

Drug Name

RITALIN-SR

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-03-30

18029 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

18029

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-03-30

Regulatory Status

Discontinued

1991
12 Jun
Discontinued Application: 19667

Drug Name

SANDOSTATIN

Product Number

4

Dosage Form

-

Strength

EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-06-12

19667 / 4

Active Ingredient

OCTREOTIDE ACETATE

Application Number

19667

Product Number

4

Dosage Form

-

Strength

EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-06-12

Regulatory Status

Discontinued

1991
12 Jun
Discontinued Application: 19667

Drug Name

SANDOSTATIN

Product Number

5

Dosage Form

-

Strength

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

Approval Date

1991-06-12

19667 / 5

Active Ingredient

OCTREOTIDE ACETATE

Application Number

19667

Product Number

5

Dosage Form

-

Strength

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

Approval Date

1991-06-12

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17247

Drug Name

SANOREX

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

17247 / 1

Active Ingredient

MAZINDOL

Application Number

17247

Product Number

1

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: 17247

Drug Name

SANOREX

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

17247 / 2

Active Ingredient

MAZINDOL

Application Number

17247

Product Number

2

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: 12516

Drug Name

SANSERT

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

12516 / 1

Active Ingredient

METHYSERGIDE MALEATE

Application Number

12516

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2015
29 Oct
Discontinued Application: 207923

Drug Name

SEEBRI NEOHALER

Product Number

1

Dosage Form

-

Strength

15.6MCG/INH

Approval Date

2015-10-29

207923 / 1

Active Ingredient

GLYCOPYRROLATE

Application Number

207923

Product Number

1

Dosage Form

-

Strength

15.6MCG/INH

Approval Date

2015-10-29

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12193

Drug Name

SER-AP-ES

Product Number

5

Dosage Form

-

Strength

25MG;15MG;0.1MG

Approval Date

1982-01-01

12193 / 5

Active Ingredient

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE

Application Number

12193

Product Number

5

Dosage Form

-

Strength

25MG;15MG;0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16774

Drug Name

SERENTIL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

16774 / 1

Active Ingredient

MESORIDAZINE BESYLATE

Application Number

16774

Product Number

1

Dosage Form

-

Strength

EQ 10MG 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: 16774

Drug Name

SERENTIL

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

16774 / 2

Active Ingredient

MESORIDAZINE BESYLATE

Application Number

16774

Product Number

2

Dosage Form

-

Strength

EQ 25MG 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: 16774

Drug Name

SERENTIL

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

16774 / 3

Active Ingredient

MESORIDAZINE BESYLATE

Application Number

16774

Product Number

3

Dosage Form

-

Strength

EQ 50MG 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: 16774

Drug Name

SERENTIL

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1982-01-01

16774 / 4

Active Ingredient

MESORIDAZINE BESYLATE

Application Number

16774

Product Number

4

Dosage Form

-

Strength

EQ 100MG 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: 16775

Drug Name

SERENTIL

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/ML

Approval Date

1982-01-01

16775 / 1

Active Ingredient

MESORIDAZINE BESYLATE

Application Number

16775

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16997

Drug Name

SERENTIL

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/ML

Approval Date

1982-01-01

16997 / 1

Active Ingredient

MESORIDAZINE BESYLATE

Application Number

16997

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9115

Drug Name

SERPASIL

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

Active Ingredient

RESERPINE

Application Number

9115

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9115

Drug Name

SERPASIL

Product Number

3

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

Active Ingredient

RESERPINE

Application Number

9115

Product Number

3

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9115

Drug Name

SERPASIL

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Active Ingredient

RESERPINE

Application Number

9115

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9115

Drug Name

SERPASIL

Product Number

5

Dosage Form

-

Strength

0.2MG/4ML

Approval Date

1982-01-01

Active Ingredient

RESERPINE

Application Number

9115

Product Number

5

Dosage Form

-

Strength

0.2MG/4ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9434

Drug Name

SERPASIL

Product Number

2

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1982-01-01

Active Ingredient

RESERPINE

Application Number

9434

Product Number

2

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9296

Drug Name

SERPASIL-APRESOLINE

Product Number

2

Dosage Form

-

Strength

50MG;0.2MG

Approval Date

1982-01-01

Active Ingredient

HYDRALAZINE HYDROCHLORIDE; RESERPINE

Application Number

9296

Product Number

2

Dosage Form

-

Strength

50MG;0.2MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9296

Drug Name

SERPASIL-APRESOLINE

Product Number

4

Dosage Form

-

Strength

25MG;0.1MG

Approval Date

1982-01-01

Active Ingredient

HYDRALAZINE HYDROCHLORIDE; RESERPINE

Application Number

9296

Product Number

4

Dosage Form

-

Strength

25MG;0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11878

Drug Name

SERPASIL-ESIDRIX #1

Product Number

3

Dosage Form

-

Strength

25MG;0.1MG

Approval Date

1982-01-01

11878 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; RESERPINE

Application Number

11878

Product Number

3

Dosage Form

-

Strength

25MG;0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11878

Drug Name

SERPASIL-ESIDRIX #2

Product Number

5

Dosage Form

-

Strength

50MG;0.1MG

Approval Date

1982-01-01

11878 / 5

Active Ingredient

HYDROCHLOROTHIAZIDE; RESERPINE

Application Number

11878

Product Number

5

Dosage Form

-

Strength

50MG;0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17476

Drug Name

SLOW-K

Product Number

2

Dosage Form

-

Strength

8MEQ

Approval Date

1982-01-01

17476 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

17476

Product Number

2

Dosage Form

-

Strength

8MEQ

Approval Date

1982-01-01

Regulatory Status

Discontinued

2000
22 Dec
Discontinued Application: 21204

Drug Name

STARLIX

Product Number

1

Dosage Form

-

Strength

60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-12-22

21204 / 1

Active Ingredient

NATEGLINIDE

Application Number

21204

Product Number

1

Dosage Form

-

Strength

60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-12-22

Regulatory Status

Discontinued

2000
22 Dec
Discontinued Application: 21204

Drug Name

STARLIX

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2000-12-22

21204 / 2

Active Ingredient

NATEGLINIDE

Application Number

21204

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2000-12-22

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80025

Drug Name

SULF-10

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1982-01-01

80025 / 1

Active Ingredient

SULFACETAMIDE SODIUM

Application Number

80025

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1995
31 Oct
Discontinued Application: 89047

Drug Name

SULF-15

Product Number

1

Dosage Form

-

Strength

15%

Approval Date

1995-10-31

89047 / 1

Active Ingredient

SULFACETAMIDE SODIUM

Application Number

89047

Product Number

1

Dosage Form

-

Strength

15%

Approval Date

1995-10-31

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18245

Drug Name

SYNTOCINON

Product Number

1

Dosage Form

-

Strength

10USP UNITS/ML

Approval Date

1982-01-01

18245 / 1

Active Ingredient

OXYTOCIN

Application Number

18245

Product Number

1

Dosage Form

-

Strength

10USP UNITS/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
03 Sep
Discontinued Application: 12542

Drug Name

TANDEARIL

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1982-09-03

12542 / 4

Active Ingredient

OXYPHENBUTAZONE

Application Number

12542

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1982-09-03

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17661

Drug Name

TAVIST

Product Number

1

Dosage Form

-

Strength

2.68MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17661 / 1

Active Ingredient

CLEMASTINE FUMARATE

Application Number

17661

Product Number

1

Dosage Form

-

Strength

2.68MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985
28 Jun
Discontinued Application: 18675

Drug Name

TAVIST

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-06-28

18675 / 1

Active Ingredient

CLEMASTINE FUMARATE

Application Number

18675

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-06-28

Regulatory Status

Discontinued

2001
01 Mar
Discontinued Application: 21082

Drug Name

TAVIST ALLERGY/SINUS/HEADACHE

Product Number

1

Dosage Form

-

Strength

500MG;EQ 0.25MG BASE;30MG

Approval Date

2001-03-01

21082 / 1

Active Ingredient

ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

21082

Product Number

1

Dosage Form

-

Strength

500MG;EQ 0.25MG BASE;30MG

Approval Date

2001-03-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17661

Drug Name

TAVIST-1

Product Number

2

Dosage Form

-

Strength

1.34MG

Approval Date

1982-01-01

17661 / 2

Active Ingredient

CLEMASTINE FUMARATE

Application Number

17661

Product Number

2

Dosage Form

-

Strength

1.34MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1992
21 Aug
Discontinued Application: 17661

Drug Name

TAVIST-1

Product Number

3

Dosage Form

-

Strength

1.34MG

Approval Date

1992-08-21

17661 / 3

Active Ingredient

CLEMASTINE FUMARATE

Application Number

17661

Product Number

3

Dosage Form

-

Strength

1.34MG

Approval Date

1992-08-21

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18281

Drug Name

TEGRETOL

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

18281 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

18281

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

2010
26 Aug
Discontinued Application: 22545

Drug Name

TEKAMLO

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE;EQ 5MG BASE

Approval Date

2010-08-26

22545 / 1

Active Ingredient

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

Application Number

22545

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE;EQ 5MG BASE

Approval Date

2010-08-26

Regulatory Status

Discontinued

2010
26 Aug
Discontinued Application: 22545

Drug Name

TEKAMLO

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE;EQ 10MG BASE

Approval Date

2010-08-26

22545 / 2

Active Ingredient

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

Application Number

22545

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE;EQ 10MG BASE

Approval Date

2010-08-26

Regulatory Status

Discontinued

2010
26 Aug
Discontinued Application: 22545

Drug Name

TEKAMLO

Product Number

3

Dosage Form

-

Strength

EQ 300MG BASE;EQ 5MG BASE

Approval Date

2010-08-26

22545 / 3

Active Ingredient

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

Application Number

22545

Product Number

3

Dosage Form

-

Strength

EQ 300MG BASE;EQ 5MG BASE

Approval Date

2010-08-26

Regulatory Status

Discontinued

2010
26 Aug
Discontinued Application: 22545

Drug Name

TEKAMLO

Product Number

4

Dosage Form

-

Strength

EQ 300MG BASE;EQ 10MG BASE

Approval Date

2010-08-26

22545 / 4

Active Ingredient

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

Application Number

22545

Product Number

4

Dosage Form

-

Strength

EQ 300MG BASE;EQ 10MG BASE

Approval Date

2010-08-26

Regulatory Status

Discontinued

1986
16 Apr
Discontinued Application: 19381

Drug Name

TEN-K

Product Number

1

Dosage Form

-

Strength

10MEQ

Approval Date

1986-04-16

19381 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

19381

Product Number

1

Dosage Form

-

Strength

10MEQ

Approval Date

1986-04-16

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50541

Drug Name

TOBREX

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

50541 / 1

Active Ingredient

TOBRAMYCIN

Application Number

50541

Product Number

1

Dosage Form

-

Strength

0.3% **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: 11838

Drug Name

TOFRANIL

Product Number

2

Dosage Form

-

Strength

12.5MG/ML

Approval Date

1982-01-01

11838 / 2

Active Ingredient

IMIPRAMINE HYDROCHLORIDE

Application Number

11838

Product Number

2

Dosage Form

-

Strength

12.5MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12753

Drug Name

TORECAN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

12753 / 1

Active Ingredient

THIETHYLPERAZINE MALEATE

Application Number

12753

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12754

Drug Name

TORECAN

Product Number

2

Dosage Form

-

Strength

5MG/ML

Approval Date

1982-01-01

12754 / 2

Active Ingredient

THIETHYLPERAZINE MALATE

Application Number

12754

Product Number

2

Dosage Form

-

Strength

5MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 13247

Drug Name

TORECAN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

13247 / 1

Active Ingredient

THIETHYLPERAZINE MALEATE

Application Number

13247

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996
27 Feb
Discontinued Application: 20144

Drug Name

TRANSDERM-NITRO

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1996-02-27

20144 / 1

Active Ingredient

NITROGLYCERIN

Application Number

20144

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1996-02-27

Regulatory Status

Discontinued

1996
27 Feb
Discontinued Application: 20144

Drug Name

TRANSDERM-NITRO

Product Number

2

Dosage Form

-

Strength

0.2MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-02-27

20144 / 2

Active Ingredient

NITROGLYCERIN

Application Number

20144

Product Number

2

Dosage Form

-

Strength

0.2MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-02-27

Regulatory Status

Discontinued

1996
27 Feb
Discontinued Application: 20144

Drug Name

TRANSDERM-NITRO

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1996-02-27

20144 / 3

Active Ingredient

NITROGLYCERIN

Application Number

20144

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1996-02-27

Regulatory Status

Discontinued

1996
27 Feb
Discontinued Application: 20144

Drug Name

TRANSDERM-NITRO

Product Number

4

Dosage Form

-

Strength

0.6MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-02-27

20144 / 4

Active Ingredient

NITROGLYCERIN

Application Number

20144

Product Number

4

Dosage Form

-

Strength

0.6MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-02-27

Regulatory Status

Discontinued

1996
27 Feb
Discontinued Application: 20144

Drug Name

TRANSDERM-NITRO

Product Number

5

Dosage Form

-

Strength

0.8MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-02-27

20144 / 5

Active Ingredient

NITROGLYCERIN

Application Number

20144

Product Number

5

Dosage Form

-

Strength

0.8MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-02-27

Regulatory Status

Discontinued

1983
28 Dec
Discontinued Application: 18166

Drug Name

TRASICOR

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1983-12-28

18166 / 1

Active Ingredient

OXPRENOLOL HYDROCHLORIDE

Application Number

18166

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1983-12-28

Regulatory Status

Discontinued

1983
28 Dec
Discontinued Application: 18166

Drug Name

TRASICOR

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

1983-12-28

18166 / 2

Active Ingredient

OXPRENOLOL HYDROCHLORIDE

Application Number

18166

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

1983-12-28

Regulatory Status

Discontinued

1983
28 Dec
Discontinued Application: 18166

Drug Name

TRASICOR

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

1983-12-28

18166 / 3

Active Ingredient

OXPRENOLOL HYDROCHLORIDE

Application Number

18166

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

1983-12-28

Regulatory Status

Discontinued

1983
28 Dec
Discontinued Application: 18166

Drug Name

TRASICOR

Product Number

4

Dosage Form

-

Strength

160MG

Approval Date

1983-12-28

18166 / 4

Active Ingredient

OXPRENOLOL HYDROCHLORIDE

Application Number

18166

Product Number

4

Dosage Form

-

Strength

160MG

Approval Date

1983-12-28

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 13420

Drug Name

TREST

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

13420 / 1

Active Ingredient

METHIXENE HYDROCHLORIDE

Application Number

13420

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18115

Drug Name

TRIAMINIC-12

Product Number

1

Dosage Form

-

Strength

12MG;75MG

Approval Date

1982-01-01

18115 / 1

Active Ingredient

CHLORPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE

Application Number

18115

Product Number

1

Dosage Form

-

Strength

12MG;75MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1997
09 Sep
Discontinued Application: 74857

Drug Name

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG;37.5MG

Approval Date

1997-09-09

74857 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; TRIAMTERENE

Application Number

74857

Product Number

1

Dosage Form

-

Strength

25MG;37.5MG

Approval Date

1997-09-09

Regulatory Status

Discontinued

2006
25 Oct
Discontinued Application: 22011

Drug Name

TYZEKA

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2006-10-25

22011 / 1

Active Ingredient

TELBIVUDINE

Application Number

22011

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2006-10-25

Regulatory Status

Discontinued

2009
28 Apr
Discontinued Application: 22154

Drug Name

TYZEKA

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2009-04-28

22154 / 1

Active Ingredient

TELBIVUDINE

Application Number

22154

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2009-04-28

Regulatory Status

Discontinued

2015
29 Oct
Discontinued Application: 207930

Drug Name

UTIBRON NEOHALER

Product Number

1

Dosage Form

-

Strength

15.6MCG/INH;27.5MCG/INH

Approval Date

2015-10-29

207930 / 1

Active Ingredient

GLYCOPYRROLATE; INDACATEROL MALEATE

Application Number

207930

Product Number

1

Dosage Form

-

Strength

15.6MCG/INH;27.5MCG/INH

Approval Date

2015-10-29

Regulatory Status

Discontinued

2009
16 Sep
Discontinued Application: 22217

Drug Name

VALTURNA

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE;160MG

Approval Date

2009-09-16

22217 / 1

Active Ingredient

ALISKIREN HEMIFUMARATE; VALSARTAN

Application Number

22217

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE;160MG

Approval Date

2009-09-16

Regulatory Status

Discontinued

2009
16 Sep
Discontinued Application: 22217

Drug Name

VALTURNA

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE;320MG

Approval Date

2009-09-16

22217 / 2

Active Ingredient

ALISKIREN HEMIFUMARATE; VALSARTAN

Application Number

22217

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE;320MG

Approval Date

2009-09-16

Regulatory Status

Discontinued

1988
26 Aug
Discontinued Application: 18988

Drug Name

VASOCIDIN

Product Number

1

Dosage Form

-

Strength

EQ 0.23% PHOSPHATE;10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1988-08-26

18988 / 1

Active Ingredient

PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM

Application Number

18988

Product Number

1

Dosage Form

-

Strength

EQ 0.23% PHOSPHATE;10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1988-08-26

Regulatory Status

Discontinued

1984
05 Oct
Discontinued Application: 88791

Drug Name

VASOCIDIN

Product Number

1

Dosage Form

-

Strength

0.5%;10%

Approval Date

1984-10-05

88791 / 1

Active Ingredient

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

Application Number

88791

Product Number

1

Dosage Form

-

Strength

0.5%;10%

Approval Date

1984-10-05

Regulatory Status

Discontinued

1983
24 Mar
Discontinued Application: 80235

Drug Name

VASOCON

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

1983-03-24

80235 / 2

Active Ingredient

NAPHAZOLINE HYDROCHLORIDE

Application Number

80235

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

1983-03-24

Regulatory Status

Discontinued

1994
11 Jul
Discontinued Application: 18746

Drug Name

VASOCON-A

Product Number

2

Dosage Form

-

Strength

0.5%;0.05%

Approval Date

1994-07-11

18746 / 2

Active Ingredient

ANTAZOLINE PHOSPHATE; NAPHAZOLINE HYDROCHLORIDE

Application Number

18746

Product Number

2

Dosage Form

-

Strength

0.5%;0.05%

Approval Date

1994-07-11

Regulatory Status

Discontinued

1987
22 Jul
Discontinued Application: 18872

Drug Name

VISKAZIDE

Product Number

1

Dosage Form

-

Strength

25MG;5MG

Approval Date

1987-07-22

18872 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; PINDOLOL

Application Number

18872

Product Number

1

Dosage Form

-

Strength

25MG;5MG

Approval Date

1987-07-22

Regulatory Status

Discontinued

1987
22 Jul
Discontinued Application: 18872

Drug Name

VISKAZIDE

Product Number

2

Dosage Form

-

Strength

25MG;10MG

Approval Date

1987-07-22

18872 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; PINDOLOL

Application Number

18872

Product Number

2

Dosage Form

-

Strength

25MG;10MG

Approval Date

1987-07-22

Regulatory Status

Discontinued

1982
03 Sep
Discontinued Application: 18285

Drug Name

VISKEN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-09-03

18285 / 1

Active Ingredient

PINDOLOL

Application Number

18285

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-09-03

Regulatory Status

Discontinued

1982
03 Sep
Discontinued Application: 18285

Drug Name

VISKEN

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-09-03

18285 / 2

Active Ingredient

PINDOLOL

Application Number

18285

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-09-03

Regulatory Status

Discontinued

1998
26 Aug
Discontinued Application: 20961

Drug Name

VITRAVENE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

6.6MG/ML

Approval Date

1998-08-26

20961 / 1

Active Ingredient

FOMIVIRSEN SODIUM

Application Number

20961

Product Number

1

Dosage Form

-

Strength

6.6MG/ML

Approval Date

1998-08-26

Regulatory Status

Discontinued

1988
28 Jul
Discontinued Application: 19201

Drug Name

VOLTAREN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1988-07-28

19201 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

19201

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1988-07-28

Regulatory Status

Discontinued

1988
28 Jul
Discontinued Application: 19201

Drug Name

VOLTAREN

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1988-07-28

19201 / 2

Active Ingredient

DICLOFENAC SODIUM

Application Number

19201

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1988-07-28

Regulatory Status

Discontinued

1988
28 Jul
Discontinued Application: 19201

Drug Name

VOLTAREN

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1988-07-28

19201 / 3

Active Ingredient

DICLOFENAC SODIUM

Application Number

19201

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1988-07-28

Regulatory Status

Discontinued

1991
28 Mar
Discontinued Application: 20037

Drug Name

VOLTAREN

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1991-03-28

20037 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

20037

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1991-03-28

Regulatory Status

Discontinued

1996
08 Mar
Discontinued Application: 20254

Drug Name

VOLTAREN-XR

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1996-03-08

20254 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

20254

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1996-03-08

Regulatory Status

Discontinued

2009
19 Oct
Discontinued Application: 22465

Drug Name

VOTRIENT

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2009-10-19

22465 / 2

Active Ingredient

PAZOPANIB HYDROCHLORIDE

Application Number

22465

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2009-10-19

Regulatory Status

Discontinued

2001
20 Aug
Discontinued Application: 21223

Drug Name

ZOMETA

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2001-08-20

21223 / 1

Active Ingredient

ZOLEDRONIC ACID

Application Number

21223

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2001-08-20

Regulatory Status

Discontinued

2003
07 Mar
Discontinued Application: 21223

Drug Name

ZOMETA

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-03-07

21223 / 2

Active Ingredient

ZOLEDRONIC ACID

Application Number

21223

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-03-07

Regulatory Status

Discontinued

2011
17 Jun
Discontinued Application: 21223

Drug Name

ZOMETA

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2011-06-17

21223 / 3

Active Ingredient

ZOLEDRONIC ACID

Application Number

21223

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2011-06-17

Regulatory Status

Discontinued

2014
29 Apr
Discontinued Application: 205755

Drug Name

ZYKADIA

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2014-04-29

205755 / 1

Active Ingredient

CERITINIB

Application Number

205755

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2014-04-29

Regulatory Status

Discontinued

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Drug Status Breakdown
217 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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FDA Approved Drug Record Details Preview

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

Drug Name

ACYLANID

Application Number

9436

Product Number

1

Active Ingredient

ACETYLDIGITOXIN

Dosage Form

-

Strength

0.1MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

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