F. Hoffmann-La Roche Discontinued
FDA Approved Drugs

F. Hoffmann-La Roche 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 131
  • Latest Approval Date Jul 02, 2007
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
139
View
Unclassified
1
View
Discontinued
131
View
RX
7
View
Company Overview

Company

F. Hoffmann-La Roche Discontinued

Country

Switzerland

Social Profiles

Company Snapshot

F. Hoffmann-La Roche Discontinued

Konzern-Hauptsitz Grenzacherstrasse 124 CH-4070 Basel

Switzerland

www.roche.com/ rocheirna@gene.com View on Map
FDA Approved Drug Records ( 131 records )
1982
07 May
Discontinued Application: 18662

Drug Name

ACCUTANE

Product Number

2

Dosage Form

-

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-05-07

18662 / 2

Active Ingredient

ISOTRETINOIN

Application Number

18662

Product Number

2

Dosage Form

-

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-05-07

Regulatory Status

Discontinued

1982
07 May
Discontinued Application: 18662

Drug Name

ACCUTANE

Product Number

3

Dosage Form

-

Strength

40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-05-07

18662 / 3

Active Ingredient

ISOTRETINOIN

Application Number

18662

Product Number

3

Dosage Form

-

Strength

40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-05-07

Regulatory Status

Discontinued

1983
28 Mar
Discontinued Application: 18662

Drug Name

ACCUTANE

Product Number

4

Dosage Form

-

Strength

20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1983-03-28

18662 / 4

Active Ingredient

ISOTRETINOIN

Application Number

18662

Product Number

4

Dosage Form

-

Strength

20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1983-03-28

Regulatory Status

Discontinued

1984
17 Aug
Discontinued Application: 18340

Drug Name

AEROBID

Product Number

1

Dosage Form

-

Strength

0.25MG/INH

Approval Date

1984-08-17

18340 / 1

Active Ingredient

FLUNISOLIDE

Application Number

18340

Product Number

1

Dosage Form

-

Strength

0.25MG/INH

Approval Date

1984-08-17

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8983

Drug Name

ARFONAD

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

Active Ingredient

TRIMETHAPHAN CAMSYLATE

Application Number

8983

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1987
10 Sep
Discontinued Application: 13294

Drug Name

AZO GANTANOL

Product Number

1

Dosage Form

-

Strength

100MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-09-10

13294 / 1

Active Ingredient

PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE

Application Number

13294

Product Number

1

Dosage Form

-

Strength

100MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-09-10

Regulatory Status

Discontinued

1990
31 Aug
Discontinued Application: 19358

Drug Name

AZO GANTRISIN

Product Number

1

Dosage Form

-

Strength

50MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-08-31

19358 / 1

Active Ingredient

PHENAZOPYRIDINE HYDROCHLORIDE; SULFISOXAZOLE

Application Number

19358

Product Number

1

Dosage Form

-

Strength

50MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-08-31

Regulatory Status

Discontinued

1985
10 Oct
Discontinued Application: 6071

Drug Name

BEROCCA PN

Product Number

3

Dosage Form

-

Strength

50MG/ML;0.03MG/ML;0.0025MG/ML;7.5MG/ML;100 IU/ML;0.2MG/ML;20MG/ML;2MG/ML;1.8MG/ML;1.5MG/ML;1,650 IU/ML;5 IU/ML

Approval Date

1985-10-10

Active Ingredient

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN E

Application Number

6071

Product Number

3

Dosage Form

-

Strength

50MG/ML;0.03MG/ML;0.0025MG/ML;7.5MG/ML;100 IU/ML;0.2MG/ML;20MG/ML;2MG/ML;1.8MG/ML;1.5MG/ML;1,650 IU/ML;5 IU/ML

Approval Date

1985-10-10

Regulatory Status

Discontinued

2003
16 May
Discontinued Application: 21455

Drug Name

BONIVA

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2003-05-16

21455 / 1

Active Ingredient

IBANDRONATE SODIUM

Application Number

21455

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2003-05-16

Regulatory Status

Discontinued

2005
24 Mar
Discontinued Application: 21455

Drug Name

BONIVA

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2005-03-24

21455 / 2

Active Ingredient

IBANDRONATE SODIUM

Application Number

21455

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2005-03-24

Regulatory Status

Discontinued

2006
06 Jan
Discontinued Application: 21858

Drug Name

BONIVA

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2006-01-06

21858 / 1

Active Ingredient

IBANDRONATE SODIUM

Application Number

21858

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2006-01-06

Regulatory Status

Discontinued

1984
21 Dec
Discontinued Application: 50565

Drug Name

COACTIN

Product Number

1

Dosage Form

-

Strength

250MG/VIAL

Approval Date

1984-12-21

50565 / 1

Active Ingredient

AMDINOCILLIN

Application Number

50565

Product Number

1

Dosage Form

-

Strength

250MG/VIAL

Approval Date

1984-12-21

Regulatory Status

Discontinued

1984
21 Dec
Discontinued Application: 50565

Drug Name

COACTIN

Product Number

2

Dosage Form

-

Strength

500MG/VIAL

Approval Date

1984-12-21

50565 / 2

Active Ingredient

AMDINOCILLIN

Application Number

50565

Product Number

2

Dosage Form

-

Strength

500MG/VIAL

Approval Date

1984-12-21

Regulatory Status

Discontinued

1984
21 Dec
Discontinued Application: 50565

Drug Name

COACTIN

Product Number

3

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1984-12-21

50565 / 3

Active Ingredient

AMDINOCILLIN

Application Number

50565

Product Number

3

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1984-12-21

Regulatory Status

Discontinued

2002
03 Dec
Discontinued Application: 21511

Drug Name

COPEGUS

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2002-12-03

21511 / 1

Active Ingredient

RIBAVIRIN

Application Number

21511

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2002-12-03

Regulatory Status

Discontinued

2005
21 Jun
Discontinued Application: 21511

Drug Name

COPEGUS

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2005-06-21

21511 / 2

Active Ingredient

RIBAVIRIN

Application Number

21511

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2005-06-21

Regulatory Status

Discontinued

1994
22 Dec
Discontinued Application: 20460

Drug Name

CYTOVENE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1994-12-22

20460 / 1

Active Ingredient

GANCICLOVIR

Application Number

20460

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1994-12-22

Regulatory Status

Discontinued

1997
12 Dec
Discontinued Application: 20460

Drug Name

CYTOVENE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1997-12-12

20460 / 2

Active Ingredient

GANCICLOVIR

Application Number

20460

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1997-12-12

Regulatory Status

Discontinued

1993
23 Aug
Discontinued Application: 20137

Drug Name

DEMADEX

Product Number

1

Dosage Form

-

Strength

20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-08-23

20137 / 1

Active Ingredient

TORSEMIDE

Application Number

20137

Product Number

1

Dosage Form

-

Strength

20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-08-23

Regulatory Status

Discontinued

1993
23 Aug
Discontinued Application: 20137

Drug Name

DEMADEX

Product Number

2

Dosage Form

-

Strength

50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-08-23

20137 / 2

Active Ingredient

TORSEMIDE

Application Number

20137

Product Number

2

Dosage Form

-

Strength

50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-08-23

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83639

Drug Name

ENDEP

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

83639 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

83639

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83639

Drug Name

ENDEP

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

83639 / 2

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

83639

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83639

Drug Name

ENDEP

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

83639 / 3

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

83639

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83639

Drug Name

ENDEP

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

1982-01-01

83639 / 4

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

83639

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83639

Drug Name

ENDEP

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

83639 / 5

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

83639

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85303

Drug Name

ENDEP

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1982-01-01

85303 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

85303

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85749

Drug Name

ENDEP

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

85749 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

85749

Product Number

1

Dosage Form

-

Strength

40MG/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: 83376

Drug Name

EVEX

Product Number

2

Dosage Form

-

Strength

1.25MG

Approval Date

1982-01-01

83376 / 2

Active Ingredient

ESTROGENS, ESTERIFIED

Application Number

83376

Product Number

2

Dosage Form

-

Strength

1.25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84215

Drug Name

EVEX

Product Number

1

Dosage Form

-

Strength

0.625MG

Approval Date

1982-01-01

84215 / 1

Active Ingredient

ESTROGENS, ESTERIFIED

Application Number

84215

Product Number

1

Dosage Form

-

Strength

0.625MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18557

Drug Name

FANSIDAR

Product Number

1

Dosage Form

-

Strength

25MG;500MG

Approval Date

1982-01-01

18557 / 1

Active Ingredient

PYRIMETHAMINE; SULFADOXINE

Application Number

18557

Product Number

1

Dosage Form

-

Strength

25MG;500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985
25 Nov
Discontinued Application: 19215

Drug Name

FEMSTAT

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1985-11-25

19215 / 1

Active Ingredient

BUTOCONAZOLE NITRATE

Application Number

19215

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1985-11-25

Regulatory Status

Discontinued

1985
25 Nov
Discontinued Application: 19359

Drug Name

FEMSTAT

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1985-11-25

19359 / 1

Active Ingredient

BUTOCONAZOLE NITRATE

Application Number

19359

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1985-11-25

Regulatory Status

Discontinued

1997
07 Nov
Discontinued Application: 20828

Drug Name

FORTOVASE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1997-11-07

20828 / 1

Active Ingredient

SAQUINAVIR

Application Number

20828

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1997-11-07

Regulatory Status

Discontinued

2003
13 Mar
Discontinued Application: 21481

Drug Name

FUZEON

Product Number

1

Dosage Form

-

Strength

90MG/VIAL

Approval Date

2003-03-13

21481 / 1

Active Ingredient

ENFUVIRTIDE

Application Number

21481

Product Number

1

Dosage Form

-

Strength

90MG/VIAL

Approval Date

2003-03-13

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12715

Drug Name

GANTANOL

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

12715 / 2

Active Ingredient

SULFAMETHOXAZOLE

Application Number

12715

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 13664

Drug Name

GANTANOL

Product Number

2

Dosage Form

-

Strength

500MG/5ML

Approval Date

1982-01-01

13664 / 2

Active Ingredient

SULFAMETHOXAZOLE

Application Number

13664

Product Number

2

Dosage Form

-

Strength

500MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12715

Drug Name

GANTANOL-DS

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

1982-01-01

12715 / 3

Active Ingredient

SULFAMETHOXAZOLE

Application Number

12715

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 6525

Drug Name

GANTRISIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Active Ingredient

SULFISOXAZOLE

Application Number

6525

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 6917

Drug Name

GANTRISIN

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE/ML

Approval Date

1982-01-01

Active Ingredient

SULFISOXAZOLE DIOLAMINE

Application Number

6917

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 7757

Drug Name

GANTRISIN

Product Number

2

Dosage Form

-

Strength

EQ 4% BASE

Approval Date

1982-01-01

Active Ingredient

SULFISOXAZOLE DIOLAMINE

Application Number

7757

Product Number

2

Dosage Form

-

Strength

EQ 4% BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8414

Drug Name

GANTRISIN

Product Number

2

Dosage Form

-

Strength

EQ 4% BASE

Approval Date

1982-01-01

Active Ingredient

SULFISOXAZOLE DIOLAMINE

Application Number

8414

Product Number

2

Dosage Form

-

Strength

EQ 4% BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9182

Drug Name

GANTRISIN

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/5ML

Approval Date

1982-01-01

Active Ingredient

SULFISOXAZOLE ACETYL

Application Number

9182

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9182

Drug Name

GANTRISIN PEDIATRIC

Product Number

4

Dosage Form

-

Strength

EQ 500MG BASE/5ML

Approval Date

1982-01-01

Active Ingredient

SULFISOXAZOLE ACETYL

Application Number

9182

Product Number

4

Dosage Form

-

Strength

EQ 500MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1992
19 Jun
Discontinued Application: 20199

Drug Name

HIVID

Product Number

1

Dosage Form

-

Strength

0.375MG

Approval Date

1992-06-19

20199 / 1

Active Ingredient

ZALCITABINE

Application Number

20199

Product Number

1

Dosage Form

-

Strength

0.375MG

Approval Date

1992-06-19

Regulatory Status

Discontinued

1992
19 Jun
Discontinued Application: 20199

Drug Name

HIVID

Product Number

2

Dosage Form

-

Strength

0.75MG

Approval Date

1992-06-19

20199 / 2

Active Ingredient

ZALCITABINE

Application Number

20199

Product Number

2

Dosage Form

-

Strength

0.75MG

Approval Date

1992-06-19

Regulatory Status

Discontinued

1995
06 Dec
Discontinued Application: 20628

Drug Name

INVIRASE

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

1995-12-06

20628 / 1

Active Ingredient

SAQUINAVIR MESYLATE

Application Number

20628

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

1995-12-06

Regulatory Status

Discontinued

1997
23 Dec
Discontinued Application: 20813

Drug Name

KLONOPIN RAPIDLY DISINTEGRATING

Product Number

1

Dosage Form

-

Strength

0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-12-23

20813 / 1

Active Ingredient

CLONAZEPAM

Application Number

20813

Product Number

1

Dosage Form

-

Strength

0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-12-23

Regulatory Status

Discontinued

1997
23 Dec
Discontinued Application: 20813

Drug Name

KLONOPIN RAPIDLY DISINTEGRATING

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1997-12-23

20813 / 2

Active Ingredient

CLONAZEPAM

Application Number

20813

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1997-12-23

Regulatory Status

Discontinued

1997
23 Dec
Discontinued Application: 20813

Drug Name

KLONOPIN RAPIDLY DISINTEGRATING

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

1997-12-23

20813 / 3

Active Ingredient

CLONAZEPAM

Application Number

20813

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

1997-12-23

Regulatory Status

Discontinued

1997
23 Dec
Discontinued Application: 20813

Drug Name

KLONOPIN RAPIDLY DISINTEGRATING

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1997-12-23

20813 / 4

Active Ingredient

CLONAZEPAM

Application Number

20813

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1997-12-23

Regulatory Status

Discontinued

1997
23 Dec
Discontinued Application: 20813

Drug Name

KLONOPIN RAPIDLY DISINTEGRATING

Product Number

5

Dosage Form

-

Strength

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

Approval Date

1997-12-23

20813 / 5

Active Ingredient

CLONAZEPAM

Application Number

20813

Product Number

5

Dosage Form

-

Strength

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

Approval Date

1997-12-23

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11745

Drug Name

KONAKION

Product Number

1

Dosage Form

-

Strength

1MG/0.5ML

Approval Date

1982-01-01

11745 / 1

Active Ingredient

PHYTONADIONE

Application Number

11745

Product Number

1

Dosage Form

-

Strength

1MG/0.5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11745

Drug Name

KONAKION

Product Number

3

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-01-01

11745 / 3

Active Ingredient

PHYTONADIONE

Application Number

11745

Product Number

3

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1993
29 Dec
Discontinued Application: 20239

Drug Name

KYTRIL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1993-12-29

20239 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

20239

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1993-12-29

Regulatory Status

Discontinued

1994
11 Mar
Discontinued Application: 20239

Drug Name

KYTRIL

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1994-03-11

20239 / 2

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

20239

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1994-03-11

Regulatory Status

Discontinued

2004
17 Sep
Discontinued Application: 20239

Drug Name

KYTRIL

Product Number

3

Dosage Form

-

Strength

EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-09-17

20239 / 3

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

20239

Product Number

3

Dosage Form

-

Strength

EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-09-17

Regulatory Status

Discontinued

1994
11 Mar
Discontinued Application: 20239

Drug Name

KYTRIL

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1994-03-11

20239 / 4

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

20239

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1994-03-11

Regulatory Status

Discontinued

1995
16 Mar
Discontinued Application: 20305

Drug Name

KYTRIL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1995-03-16

20305 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

20305

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1995-03-16

Regulatory Status

Discontinued

1998
15 Jun
Discontinued Application: 20305

Drug Name

KYTRIL

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1998-06-15

20305 / 2

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

20305

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1998-06-15

Regulatory Status

Discontinued

2001
27 Jun
Discontinued Application: 21238

Drug Name

KYTRIL

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/10ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-06-27

21238 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

21238

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/10ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-06-27

Regulatory Status

Discontinued

1989
02 May
Discontinued Application: 19591

Drug Name

LARIAM

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1989-05-02

19591 / 1

Active Ingredient

MEFLOQUINE HYDROCHLORIDE

Application Number

19591

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1989-05-02

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16912

Drug Name

LARODOPA

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

16912 / 1

Active Ingredient

LEVODOPA

Application Number

16912

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16912

Drug Name

LARODOPA

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

16912 / 2

Active Ingredient

LEVODOPA

Application Number

16912

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16912

Drug Name

LARODOPA

Product Number

3

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

16912 / 3

Active Ingredient

LEVODOPA

Application Number

16912

Product Number

3

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16912

Drug Name

LARODOPA

Product Number

4

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

16912 / 4

Active Ingredient

LEVODOPA

Application Number

16912

Product Number

4

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16912

Drug Name

LARODOPA

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

16912 / 5

Active Ingredient

LEVODOPA

Application Number

16912

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16912

Drug Name

LARODOPA

Product Number

6

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

16912 / 6

Active Ingredient

LEVODOPA

Application Number

16912

Product Number

6

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9182

Drug Name

LIPO GANTRISIN

Product Number

9

Dosage Form

-

Strength

EQ 1GM BASE/5ML

Approval Date

1982-01-01

Active Ingredient

SULFISOXAZOLE ACETYL

Application Number

9182

Product Number

9

Dosage Form

-

Strength

EQ 1GM BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10423

Drug Name

LORFAN

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1982-01-01

10423 / 1

Active Ingredient

LEVALLORPHAN TARTRATE

Application Number

10423

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 14740

Drug Name

MENRIUM 10-4

Product Number

6

Dosage Form

-

Strength

10MG;0.4MG

Approval Date

1982-01-01

14740 / 6

Active Ingredient

CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED

Application Number

14740

Product Number

6

Dosage Form

-

Strength

10MG;0.4MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 14740

Drug Name

MENRIUM 5-2

Product Number

2

Dosage Form

-

Strength

5MG;0.2MG

Approval Date

1982-01-01

14740 / 2

Active Ingredient

CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED

Application Number

14740

Product Number

2

Dosage Form

-

Strength

5MG;0.2MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 14740

Drug Name

MENRIUM 5-4

Product Number

4

Dosage Form

-

Strength

5MG;0.4MG

Approval Date

1982-01-01

14740 / 4

Active Ingredient

CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED

Application Number

14740

Product Number

4

Dosage Form

-

Strength

5MG;0.4MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17546

Drug Name

NIPRIDE

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

1982-01-01

17546 / 1

Active Ingredient

SODIUM NITROPRUSSIDE

Application Number

17546

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9660

Drug Name

NOLUDAR

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Active Ingredient

METHYPRYLON

Application Number

9660

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9660

Drug Name

NOLUDAR

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Active Ingredient

METHYPRYLON

Application Number

9660

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9660

Drug Name

NOLUDAR

Product Number

7

Dosage Form

-

Strength

50MG/5ML

Approval Date

1982-01-01

Active Ingredient

METHYPRYLON

Application Number

9660

Product Number

7

Dosage Form

-

Strength

50MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9660

Drug Name

NOLUDAR

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

Active Ingredient

METHYPRYLON

Application Number

9660

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10355

Drug Name

QUARZAN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1982-01-01

10355 / 1

Active Ingredient

CLIDINIUM BROMIDE

Application Number

10355

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10355

Drug Name

QUARZAN

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

10355 / 2

Active Ingredient

CLIDINIUM BROMIDE

Application Number

10355

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1987
31 Dec
Discontinued Application: 18550

Drug Name

RIMADYL

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1987-12-31

18550 / 2

Active Ingredient

CARPROFEN

Application Number

18550

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1987-12-31

Regulatory Status

Discontinued

1987
31 Dec
Discontinued Application: 18550

Drug Name

RIMADYL

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

1987-12-31

18550 / 3

Active Ingredient

CARPROFEN

Application Number

18550

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

1987-12-31

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8420

Drug Name

RIMIFON

Product Number

1

Dosage Form

-

Strength

50MG/5ML

Approval Date

1982-01-01

Active Ingredient

ISONIAZID

Application Number

8420

Product Number

1

Dosage Form

-

Strength

50MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8420

Drug Name

RIMIFON

Product Number

2

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

Active Ingredient

ISONIAZID

Application Number

8420

Product Number

2

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8420

Drug Name

RIMIFON

Product Number

3

Dosage Form

-

Strength

100MG/ML

Approval Date

1982-01-01

Active Ingredient

ISONIAZID

Application Number

8420

Product Number

3

Dosage Form

-

Strength

100MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
21 Dec
Discontinued Application: 50585

Drug Name

ROCEPHIN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1984-12-21

50585 / 1

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

50585

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1984-12-21

Regulatory Status

Discontinued

1984
21 Dec
Discontinued Application: 50585

Drug Name

ROCEPHIN

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1984-12-21

50585 / 2

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

50585

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1984-12-21

Regulatory Status

Discontinued

1984
21 Dec
Discontinued Application: 50585

Drug Name

ROCEPHIN

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1984-12-21

50585 / 3

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

50585

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1984-12-21

Regulatory Status

Discontinued

1984
21 Dec
Discontinued Application: 50585

Drug Name

ROCEPHIN

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1984-12-21

50585 / 4

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

50585

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1984-12-21

Regulatory Status

Discontinued

1984
21 Dec
Discontinued Application: 50585

Drug Name

ROCEPHIN

Product Number

5

Dosage Form

-

Strength

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

Approval Date

1984-12-21

50585 / 5

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

50585

Product Number

5

Dosage Form

-

Strength

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

Approval Date

1984-12-21

Regulatory Status

Discontinued

1985
12 Mar
Discontinued Application: 62510

Drug Name

ROCEPHIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1985-03-12

62510 / 1

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

62510

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1985-03-12

Regulatory Status

Discontinued

1985
12 Mar
Discontinued Application: 62510

Drug Name

ROCEPHIN

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1985-03-12

62510 / 2

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

62510

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1985-03-12

Regulatory Status

Discontinued

1985
12 Mar
Discontinued Application: 62510

Drug Name

ROCEPHIN

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1985-03-12

62510 / 3

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

62510

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1985-03-12

Regulatory Status

Discontinued

1987
30 Apr
Discontinued Application: 62654

Drug Name

ROCEPHIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1987-04-30

62654 / 1

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

62654

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1987-04-30

Regulatory Status

Discontinued

1987
30 Apr
Discontinued Application: 62654

Drug Name

ROCEPHIN

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1987-04-30

62654 / 2

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

62654

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1987-04-30

Regulatory Status

Discontinued

1987
30 Apr
Discontinued Application: 62654

Drug Name

ROCEPHIN

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1987-04-30

62654 / 3

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

62654

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1987-04-30

Regulatory Status

Discontinued

1993
13 Aug
Discontinued Application: 63239

Drug Name

ROCEPHIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1993-08-13

63239 / 1

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

63239

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1993-08-13

Regulatory Status

Discontinued

1993
13 Aug
Discontinued Application: 63239

Drug Name

ROCEPHIN

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1993-08-13

63239 / 2

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

63239

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1993-08-13

Regulatory Status

Discontinued

1993
13 Aug
Discontinued Application: 63239

Drug Name

ROCEPHIN

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1993-08-13

63239 / 3

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

63239

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1993-08-13

Regulatory Status

Discontinued

1996
08 May
Discontinued Application: 50585

Drug Name

ROCEPHIN KIT

Product Number

6

Dosage Form

-

Strength

EQ 1GM BASE/VIAL,N/A;N/A,1%

Approval Date

1996-05-08

50585 / 6

Active Ingredient

CEFTRIAXONE SODIUM; LIDOCAINE

Application Number

50585

Product Number

6

Dosage Form

-

Strength

EQ 1GM BASE/VIAL,N/A;N/A,1%

Approval Date

1996-05-08

Regulatory Status

Discontinued

1996
08 May
Discontinued Application: 50585

Drug Name

ROCEPHIN KIT

Product Number

7

Dosage Form

-

Strength

EQ 500MG BASE/VIAL,N/A;N/A,1%

Approval Date

1996-05-08

50585 / 7

Active Ingredient

CEFTRIAXONE SODIUM; LIDOCAINE

Application Number

50585

Product Number

7

Dosage Form

-

Strength

EQ 500MG BASE/VIAL,N/A;N/A,1%

Approval Date

1996-05-08

Regulatory Status

Discontinued

1987
11 Feb
Discontinued Application: 50624

Drug Name

ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1987-02-11

50624 / 1

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

50624

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1987-02-11

Regulatory Status

Discontinued

1987
11 Feb
Discontinued Application: 50624

Drug Name

ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1987-02-11

50624 / 2

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

50624

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1987-02-11

Regulatory Status

Discontinued

1987
11 Feb
Discontinued Application: 50624

Drug Name

ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1987-02-11

50624 / 3

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

50624

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1987-02-11

Regulatory Status

Discontinued

1991
20 Dec
Discontinued Application: 20073

Drug Name

ROMAZICON

Product Number

1

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-12-20

20073 / 1

Active Ingredient

FLUMAZENIL

Application Number

20073

Product Number

1

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-12-20

Regulatory Status

Discontinued

1991
20 Dec
Discontinued Application: 20073

Drug Name

ROMAZICON

Product Number

2

Dosage Form

-

Strength

0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-12-20

20073 / 2

Active Ingredient

FLUMAZENIL

Application Number

20073

Product Number

2

Dosage Form

-

Strength

0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-12-20

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17589

Drug Name

SOLATENE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

17589 / 1

Active Ingredient

BETA CAROTENE

Application Number

17589

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 3718

Drug Name

SYNKAYVITE

Product Number

4

Dosage Form

-

Strength

5MG/ML

Approval Date

1982-01-01

Active Ingredient

MENADIOL SODIUM DIPHOSPHATE

Application Number

3718

Product Number

4

Dosage Form

-

Strength

5MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 3718

Drug Name

SYNKAYVITE

Product Number

6

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-01-01

Active Ingredient

MENADIOL SODIUM DIPHOSPHATE

Application Number

3718

Product Number

6

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 3718

Drug Name

SYNKAYVITE

Product Number

8

Dosage Form

-

Strength

37.5MG/ML

Approval Date

1982-01-01

Active Ingredient

MENADIOL SODIUM DIPHOSPHATE

Application Number

3718

Product Number

8

Dosage Form

-

Strength

37.5MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 3718

Drug Name

SYNKAYVITE

Product Number

10

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

3718 / 10

Active Ingredient

MENADIOL SODIUM DIPHOSPHATE

Application Number

3718

Product Number

10

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2007
02 Jul
Discontinued Application: 21087

Drug Name

TAMIFLU

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2007-07-02

21087 / 2

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

21087

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2007-07-02

Regulatory Status

Discontinued

2007
02 Jul
Discontinued Application: 21087

Drug Name

TAMIFLU

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2007-07-02

21087 / 3

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

21087

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2007-07-02

Regulatory Status

Discontinued

2000
14 Dec
Discontinued Application: 21246

Drug Name

TAMIFLU

Product Number

1

Dosage Form

-

Strength

EQ 12MG BASE/ML

Approval Date

2000-12-14

21246 / 1

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

21246

Product Number

1

Dosage Form

-

Strength

EQ 12MG BASE/ML

Approval Date

2000-12-14

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12486

Drug Name

TARACTAN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

12486 / 1

Active Ingredient

CHLORPROTHIXENE

Application Number

12486

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12486

Drug Name

TARACTAN

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

12486 / 3

Active Ingredient

CHLORPROTHIXENE

Application Number

12486

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12486

Drug Name

TARACTAN

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

12486 / 4

Active Ingredient

CHLORPROTHIXENE

Application Number

12486

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12486

Drug Name

TARACTAN

Product Number

5

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

12486 / 5

Active Ingredient

CHLORPROTHIXENE

Application Number

12486

Product Number

5

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12487

Drug Name

TARACTAN

Product Number

1

Dosage Form

-

Strength

12.5MG/ML

Approval Date

1982-01-01

12487 / 1

Active Ingredient

CHLORPROTHIXENE

Application Number

12487

Product Number

1

Dosage Form

-

Strength

12.5MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16149

Drug Name

TARACTAN

Product Number

2

Dosage Form

-

Strength

100MG/5ML

Approval Date

1982-01-01

16149 / 2

Active Ingredient

CHLORPROTHIXENE

Application Number

16149

Product Number

2

Dosage Form

-

Strength

100MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1986
30 Sep
Discontinued Application: 19369

Drug Name

TEGISON

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1986-09-30

19369 / 1

Active Ingredient

ETRETINATE

Application Number

19369

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1986-09-30

Regulatory Status

Discontinued

1986
30 Sep
Discontinued Application: 19369

Drug Name

TEGISON

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1986-09-30

19369 / 2

Active Ingredient

ETRETINATE

Application Number

19369

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1986-09-30

Regulatory Status

Discontinued

1993
24 Mar
Discontinued Application: 19979

Drug Name

TICLID

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1993-03-24

19979 / 1

Active Ingredient

TICLOPIDINE HYDROCHLORIDE

Application Number

19979

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1993-03-24

Regulatory Status

Discontinued

1991
31 Oct
Discontinued Application: 19979

Drug Name

TICLID

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

1991-10-31

19979 / 2

Active Ingredient

TICLOPIDINE HYDROCHLORIDE

Application Number

19979

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

1991-10-31

Regulatory Status

Discontinued

1991
20 Dec
Discontinued Application: 19645

Drug Name

TORADOL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1991-12-20

19645 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

19645

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1991-12-20

Regulatory Status

Discontinued

1989
30 Nov
Discontinued Application: 19698

Drug Name

TORADOL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1989-11-30

19698 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

19698

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1989-11-30

Regulatory Status

Discontinued

1989
30 Nov
Discontinued Application: 19698

Drug Name

TORADOL

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1989-11-30

19698 / 2

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

19698

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1989-11-30

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17952

Drug Name

TRIMPEX

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

17952 / 1

Active Ingredient

TRIMETHOPRIM

Application Number

17952

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
09 Nov
Discontinued Application: 17952

Drug Name

TRIMPEX 200

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1982-11-09

17952 / 2

Active Ingredient

TRIMETHOPRIM

Application Number

17952

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1982-11-09

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16087

Drug Name

VALIUM

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

16087 / 1

Active Ingredient

DIAZEPAM

Application Number

16087

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18179

Drug Name

VALRELEASE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

18179 / 1

Active Ingredient

DIAZEPAM

Application Number

18179

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1998
15 Oct
Discontinued Application: 20942

Drug Name

VERSED

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1998-10-15

20942 / 1

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

20942

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1998-10-15

Regulatory Status

Discontinued

Related Databases
  • FDA Inspections
    0 View
  • EDQM CEP
    7 View
  • KDMF
    0 View
  • Japan DMF
    0 View
  • Eudra GMP
    0 View
  • NDC Database
    0 View
  • FDA Approved Drugs Database
    139 View
  • Drug Prices in Switzerland
    0 View
Drug Status Breakdown
131 total
  • Discontinued
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

ACCUTANE

Application Number

18662

Product Number

2

Active Ingredient

ISOTRETINOIN

Dosage Form

-

Strength

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

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

Create a New Buying Request

Fields marked with * are mandatory.

Please enter quantity.
Please select a unit.
Please select quality standard.
Please select request type.
Please provide product specifications.
Please enter additional details.
Please select shipping preference.
Notice: By submitting this buying request, the provided product details and requirements may be published publicly on our marketplace.