GSK Discontinued
FDA Approved Drugs

GSK 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 296
  • Latest Approval Date Feb 01, 2023
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
377
View
Unclassified
14
View
Discontinued
296
View
RX
67
View
Company Overview

Company

GSK Discontinued

Country

United Kingdom

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Company Snapshot

GSK Discontinued

980 Great West Road, Brentford, Middlesex TW8 9GS England

United Kingdom

www.gsk.com:443/en-gb/ View on Map
FDA Approved Drug Records ( 296 records )
1983
01 Jul
Discontinued Application: 11110

Drug Name

ACTIDIL

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

1983-07-01

11110 / 2

Active Ingredient

TRIPROLIDINE HYDROCHLORIDE

Application Number

11110

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

1983-07-01

Regulatory Status

Discontinued

1983
01 Jul
Discontinued Application: 11496

Drug Name

ACTIDIL

Product Number

2

Dosage Form

-

Strength

1.25MG/5ML

Approval Date

1983-07-01

11496 / 2

Active Ingredient

TRIPROLIDINE HYDROCHLORIDE

Application Number

11496

Product Number

2

Dosage Form

-

Strength

1.25MG/5ML

Approval Date

1983-07-01

Regulatory Status

Discontinued

1985
17 Jun
Discontinued Application: 18996

Drug Name

ACTIFED

Product Number

1

Dosage Form

-

Strength

120MG;5MG

Approval Date

1985-06-17

18996 / 1

Active Ingredient

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

Application Number

18996

Product Number

1

Dosage Form

-

Strength

120MG;5MG

Approval Date

1985-06-17

Regulatory Status

Discontinued

1984
04 Apr
Discontinued Application: 12575

Drug Name

ACTIFED W/ CODEINE

Product Number

3

Dosage Form

-

Strength

10MG/5ML;30MG/5ML;1.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-04-04

12575 / 3

Active Ingredient

CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

Application Number

12575

Product Number

3

Dosage Form

-

Strength

10MG/5ML;30MG/5ML;1.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-04-04

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62036

Drug Name

AEROSPORIN

Product Number

1

Dosage Form

-

Strength

EQ 500,000 UNITS BASE/VIAL

Approval Date

1982-01-01

62036 / 1

Active Ingredient

POLYMYXIN B SULFATE

Application Number

62036

Product Number

1

Dosage Form

-

Strength

EQ 500,000 UNITS BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1999
15 Apr
Discontinued Application: 21007

Drug Name

AGENERASE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1999-04-15

21007 / 1

Active Ingredient

AMPRENAVIR

Application Number

21007

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1999-04-15

Regulatory Status

Discontinued

1999
15 Apr
Discontinued Application: 21007

Drug Name

AGENERASE

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

1999-04-15

21007 / 2

Active Ingredient

AMPRENAVIR

Application Number

21007

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

1999-04-15

Regulatory Status

Discontinued

1999
15 Apr
Discontinued Application: 21039

Drug Name

AGENERASE

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

1999-04-15

21039 / 1

Active Ingredient

AMPRENAVIR

Application Number

21039

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

1999-04-15

Regulatory Status

Discontinued

1998
10 Feb
Discontinued Application: 20763

Drug Name

AMERGE

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

1998-02-10

20763 / 1

Active Ingredient

NARATRIPTAN HYDROCHLORIDE

Application Number

20763

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

1998-02-10

Regulatory Status

Discontinued

1998
10 Feb
Discontinued Application: 20763

Drug Name

AMERGE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1998-02-10

20763 / 2

Active Ingredient

NARATRIPTAN HYDROCHLORIDE

Application Number

20763

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1998-02-10

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50459

Drug Name

AMOXIL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

50459 / 1

Active Ingredient

AMOXICILLIN

Application Number

50459

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50459

Drug Name

AMOXIL

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

50459 / 2

Active Ingredient

AMOXICILLIN

Application Number

50459

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50460

Drug Name

AMOXIL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

50460 / 1

Active Ingredient

AMOXICILLIN

Application Number

50460

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50460

Drug Name

AMOXIL

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

50460 / 2

Active Ingredient

AMOXICILLIN

Application Number

50460

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50460

Drug Name

AMOXIL

Product Number

5

Dosage Form

-

Strength

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

Approval Date

1982-01-01

50460 / 5

Active Ingredient

AMOXICILLIN

Application Number

50460

Product Number

5

Dosage Form

-

Strength

50MG/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: 50461

Drug Name

ANCEF

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

1982-01-01

50461 / 1

Active Ingredient

CEFAZOLIN SODIUM

Application Number

50461

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

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50461

Drug Name

ANCEF

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

1982-01-01

50461 / 2

Active Ingredient

CEFAZOLIN SODIUM

Application Number

50461

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

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50461

Drug Name

ANCEF

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

1982-01-01

50461 / 3

Active Ingredient

CEFAZOLIN SODIUM

Application Number

50461

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

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50461

Drug Name

ANCEF

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1982-01-01

50461 / 4

Active Ingredient

CEFAZOLIN SODIUM

Application Number

50461

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50461

Drug Name

ANCEF

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

1982-01-01

50461 / 5

Active Ingredient

CEFAZOLIN SODIUM

Application Number

50461

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

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61859

Drug Name

ANSPOR

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

61859 / 1

Active Ingredient

CEPHRADINE

Application Number

61859

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61859

Drug Name

ANSPOR

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

61859 / 2

Active Ingredient

CEPHRADINE

Application Number

61859

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61866

Drug Name

ANSPOR

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

1982-01-01

61866 / 1

Active Ingredient

CEPHRADINE

Application Number

61866

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61866

Drug Name

ANSPOR

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

1982-01-01

61866 / 2

Active Ingredient

CEPHRADINE

Application Number

61866

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9102

Drug Name

ANTEPAR

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/5ML

Approval Date

1982-01-01

Active Ingredient

PIPERAZINE CITRATE

Application Number

9102

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9102

Drug Name

ANTEPAR

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Active Ingredient

PIPERAZINE CITRATE

Application Number

9102

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1988
12 Apr
Discontinued Application: 19508

Drug Name

AXID

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1988-04-12

19508 / 1

Active Ingredient

NIZATIDINE

Application Number

19508

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1988-04-12

Regulatory Status

Discontinued

1988
12 Apr
Discontinued Application: 19508

Drug Name

AXID

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1988-04-12

19508 / 2

Active Ingredient

NIZATIDINE

Application Number

19508

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1988-04-12

Regulatory Status

Discontinued

1982
26 Mar
Discontinued Application: 61334

Drug Name

BACTOCILL

Product Number

6

Dosage Form

-

Strength

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

Approval Date

1982-03-26

61334 / 6

Active Ingredient

OXACILLIN SODIUM

Application Number

61334

Product Number

6

Dosage Form

-

Strength

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

Approval Date

1982-03-26

Regulatory Status

Discontinued

1982
26 Mar
Discontinued Application: 61334

Drug Name

BACTOCILL

Product Number

7

Dosage Form

-

Strength

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

Approval Date

1982-03-26

61334 / 7

Active Ingredient

OXACILLIN SODIUM

Application Number

61334

Product Number

7

Dosage Form

-

Strength

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

Approval Date

1982-03-26

Regulatory Status

Discontinued

1982
26 Mar
Discontinued Application: 61334

Drug Name

BACTOCILL

Product Number

8

Dosage Form

-

Strength

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

Approval Date

1982-03-26

61334 / 8

Active Ingredient

OXACILLIN SODIUM

Application Number

61334

Product Number

8

Dosage Form

-

Strength

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

Approval Date

1982-03-26

Regulatory Status

Discontinued

1982
26 Mar
Discontinued Application: 61334

Drug Name

BACTOCILL

Product Number

9

Dosage Form

-

Strength

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

Approval Date

1982-03-26

61334 / 9

Active Ingredient

OXACILLIN SODIUM

Application Number

61334

Product Number

9

Dosage Form

-

Strength

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

Approval Date

1982-03-26

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61334

Drug Name

BACTOCILL

Product Number

10

Dosage Form

-

Strength

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

Approval Date

1982-01-01

61334 / 10

Active Ingredient

OXACILLIN SODIUM

Application Number

61334

Product Number

10

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61336

Drug Name

BACTOCILL

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

61336 / 1

Active Ingredient

OXACILLIN SODIUM

Application Number

61336

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61336

Drug Name

BACTOCILL

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

61336 / 2

Active Ingredient

OXACILLIN SODIUM

Application Number

61336

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62241

Drug Name

BACTOCILL

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

62241 / 1

Active Ingredient

OXACILLIN SODIUM

Application Number

62241

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62241

Drug Name

BACTOCILL

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

62241 / 2

Active Ingredient

OXACILLIN SODIUM

Application Number

62241

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62321

Drug Name

BACTOCILL

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

62321 / 1

Active Ingredient

OXACILLIN SODIUM

Application Number

62321

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1986
19 Dec
Discontinued Application: 62736

Drug Name

BACTOCILL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1986-12-19

62736 / 1

Active Ingredient

OXACILLIN SODIUM

Application Number

62736

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1986-12-19

Regulatory Status

Discontinued

1986
19 Dec
Discontinued Application: 62736

Drug Name

BACTOCILL

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1986-12-19

62736 / 2

Active Ingredient

OXACILLIN SODIUM

Application Number

62736

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1986-12-19

Regulatory Status

Discontinued

1987
31 Dec
Discontinued Application: 50591

Drug Name

BACTROBAN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1987-12-31

50591 / 1

Active Ingredient

MUPIROCIN

Application Number

50591

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1987-12-31

Regulatory Status

Discontinued

1995
18 Sep
Discontinued Application: 50703

Drug Name

BACTROBAN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1995-09-18

50703 / 1

Active Ingredient

MUPIROCIN CALCIUM

Application Number

50703

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1995-09-18

Regulatory Status

Discontinued

1997
11 Dec
Discontinued Application: 50746

Drug Name

BACTROBAN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1997-12-11

50746 / 1

Active Ingredient

MUPIROCIN CALCIUM

Application Number

50746

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1997-12-11

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18153

Drug Name

BECLOVENT

Product Number

1

Dosage Form

-

Strength

0.042MG/INH

Approval Date

1982-01-01

18153 / 1

Active Ingredient

BECLOMETHASONE DIPROPIONATE

Application Number

18153

Product Number

1

Dosage Form

-

Strength

0.042MG/INH

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18584

Drug Name

BECONASE

Product Number

1

Dosage Form

-

Strength

0.042MG/INH

Approval Date

1982-01-01

18584 / 1

Active Ingredient

BECLOMETHASONE DIPROPIONATE

Application Number

18584

Product Number

1

Dosage Form

-

Strength

0.042MG/INH

Approval Date

1982-01-01

Regulatory Status

Discontinued

1987
27 Jul
Discontinued Application: 19389

Drug Name

BECONASE AQ

Product Number

1

Dosage Form

-

Strength

EQ 0.042MG DIPROP/SPRAY

Approval Date

1987-07-27

19389 / 1

Active Ingredient

BECLOMETHASONE DIPROPIONATE MONOHYDRATE

Application Number

19389

Product Number

1

Dosage Form

-

Strength

EQ 0.042MG DIPROP/SPRAY

Approval Date

1987-07-27

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62270

Drug Name

BEEPEN-VK

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

62270 / 1

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

62270

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62270

Drug Name

BEEPEN-VK

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

62270 / 2

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

62270

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62273

Drug Name

BEEPEN-VK

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

62273 / 1

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

62273

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62273

Drug Name

BEEPEN-VK

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

62273 / 2

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

62273

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1993
31 Oct
Discontinued Application: 64033

Drug Name

CEFAZOLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1993-10-31

64033 / 1

Active Ingredient

CEFAZOLIN SODIUM

Application Number

64033

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1993-10-31

Regulatory Status

Discontinued

1987
28 Dec
Discontinued Application: 50605

Drug Name

CEFTIN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1987-12-28

50605 / 1

Active Ingredient

CEFUROXIME AXETIL

Application Number

50605

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1987-12-28

Regulatory Status

Discontinued

1987
28 Dec
Discontinued Application: 50605

Drug Name

CEFTIN

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1987-12-28

50605 / 2

Active Ingredient

CEFUROXIME AXETIL

Application Number

50605

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1987-12-28

Regulatory Status

Discontinued

1987
28 Dec
Discontinued Application: 50605

Drug Name

CEFTIN

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1987-12-28

50605 / 3

Active Ingredient

CEFUROXIME AXETIL

Application Number

50605

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1987-12-28

Regulatory Status

Discontinued

1994
30 Jun
Discontinued Application: 50672

Drug Name

CEFTIN

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1994-06-30

50672 / 1

Active Ingredient

CEFUROXIME AXETIL

Application Number

50672

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1994-06-30

Regulatory Status

Discontinued

1997
29 Apr
Discontinued Application: 50672

Drug Name

CEFTIN

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1997-04-29

50672 / 2

Active Ingredient

CEFUROXIME AXETIL

Application Number

50672

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1997-04-29

Regulatory Status

Discontinued

1990
27 Sep
Discontinued Application: 50646

Drug Name

CEPTAZ

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

1990-09-27

50646 / 1

Active Ingredient

CEFTAZIDIME

Application Number

50646

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

1990-09-27

Regulatory Status

Discontinued

1990
27 Sep
Discontinued Application: 50646

Drug Name

CEPTAZ

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1990-09-27

50646 / 2

Active Ingredient

CEFTAZIDIME

Application Number

50646

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1990-09-27

Regulatory Status

Discontinued

1990
27 Sep
Discontinued Application: 50646

Drug Name

CEPTAZ

Product Number

3

Dosage Form

-

Strength

2GM/VIAL

Approval Date

1990-09-27

50646 / 3

Active Ingredient

CEFTAZIDIME

Application Number

50646

Product Number

3

Dosage Form

-

Strength

2GM/VIAL

Approval Date

1990-09-27

Regulatory Status

Discontinued

1990
27 Sep
Discontinued Application: 50646

Drug Name

CEPTAZ

Product Number

4

Dosage Form

-

Strength

10GM/VIAL

Approval Date

1990-09-27

50646 / 4

Active Ingredient

CEFTAZIDIME

Application Number

50646

Product Number

4

Dosage Form

-

Strength

10GM/VIAL

Approval Date

1990-09-27

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61806

Drug Name

CLOXAPEN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

61806 / 1

Active Ingredient

CLOXACILLIN SODIUM

Application Number

61806

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61806

Drug Name

CLOXAPEN

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

61806 / 2

Active Ingredient

CLOXACILLIN SODIUM

Application Number

61806

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62233

Drug Name

CLOXAPEN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

62233 / 1

Active Ingredient

CLOXACILLIN SODIUM

Application Number

62233

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62233

Drug Name

CLOXAPEN

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

62233 / 2

Active Ingredient

CLOXACILLIN SODIUM

Application Number

62233

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10571

Drug Name

COMPAZINE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

10571 / 1

Active Ingredient

PROCHLORPERAZINE MALEATE

Application Number

10571

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10571

Drug Name

COMPAZINE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

10571 / 2

Active Ingredient

PROCHLORPERAZINE MALEATE

Application Number

10571

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10571

Drug Name

COMPAZINE

Product Number

3

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

10571 / 3

Active Ingredient

PROCHLORPERAZINE MALEATE

Application Number

10571

Product Number

3

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: 10742

Drug Name

COMPAZINE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

10742 / 2

Active Ingredient

PROCHLORPERAZINE EDISYLATE

Application Number

10742

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11000

Drug Name

COMPAZINE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1982-01-01

11000 / 1

Active Ingredient

PROCHLORPERAZINE MALEATE

Application Number

11000

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11000

Drug Name

COMPAZINE

Product Number

2

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

1982-01-01

11000 / 2

Active Ingredient

PROCHLORPERAZINE MALEATE

Application Number

11000

Product Number

2

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11000

Drug Name

COMPAZINE

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

1982-01-01

11000 / 3

Active Ingredient

PROCHLORPERAZINE MALEATE

Application Number

11000

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11000

Drug Name

COMPAZINE

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

1982-01-01

11000 / 4

Active Ingredient

PROCHLORPERAZINE MALEATE

Application Number

11000

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11127

Drug Name

COMPAZINE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11127 / 1

Active Ingredient

PROCHLORPERAZINE

Application Number

11127

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11127

Drug Name

COMPAZINE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11127 / 2

Active Ingredient

PROCHLORPERAZINE

Application Number

11127

Product Number

2

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: 11127

Drug Name

COMPAZINE

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11127 / 3

Active Ingredient

PROCHLORPERAZINE

Application Number

11127

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11188

Drug Name

COMPAZINE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/5ML

Approval Date

1982-01-01

11188 / 1

Active Ingredient

PROCHLORPERAZINE EDISYLATE

Application Number

11188

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11276

Drug Name

COMPAZINE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1982-01-01

11276 / 1

Active Ingredient

PROCHLORPERAZINE EDISYLATE

Application Number

11276

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1999
06 Oct
Discontinued Application: 21019

Drug Name

COMPAZINE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1999-10-06

21019 / 1

Active Ingredient

PROCHLORPERAZINE MALEATE

Application Number

21019

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1999-10-06

Regulatory Status

Discontinued

1999
06 Oct
Discontinued Application: 21019

Drug Name

COMPAZINE

Product Number

2

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

1999-10-06

21019 / 2

Active Ingredient

PROCHLORPERAZINE MALEATE

Application Number

21019

Product Number

2

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

1999-10-06

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10744

Drug Name

DARBID

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1982-01-01

10744 / 1

Active Ingredient

ISOPROPAMIDE IODIDE

Application Number

10744

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83902

Drug Name

DEXEDRINE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

83902 / 1

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

83902

Product Number

1

Dosage Form

-

Strength

5MG/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: 84935

Drug Name

DEXEDRINE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

84935 / 1

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

84935

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9309

Drug Name

DIONOSIL AQUEOUS

Product Number

1

Dosage Form

-

Strength

50%

Approval Date

1982-01-01

Active Ingredient

PROPYLIODONE

Application Number

9309

Product Number

1

Dosage Form

-

Strength

50%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9309

Drug Name

DIONOSIL OILY

Product Number

2

Dosage Form

-

Strength

60%

Approval Date

1982-01-01

Active Ingredient

PROPYLIODONE

Application Number

9309

Product Number

2

Dosage Form

-

Strength

60%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16042

Drug Name

DYAZIDE

Product Number

2

Dosage Form

-

Strength

25MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

16042 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; TRIAMTERENE

Application Number

16042

Product Number

2

Dosage Form

-

Strength

25MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1994
03 Mar
Discontinued Application: 16042

Drug Name

DYAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1994-03-03

16042 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; TRIAMTERENE

Application Number

16042

Product Number

3

Dosage Form

-

Strength

25MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1994-03-03

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60254

Drug Name

DYCILL

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

60254 / 2

Active Ingredient

DICLOXACILLIN SODIUM

Application Number

60254

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60254

Drug Name

DYCILL

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

60254 / 3

Active Ingredient

DICLOXACILLIN SODIUM

Application Number

60254

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62238

Drug Name

DYCILL

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

62238 / 1

Active Ingredient

DICLOXACILLIN SODIUM

Application Number

62238

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62238

Drug Name

DYCILL

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

62238 / 2

Active Ingredient

DICLOXACILLIN SODIUM

Application Number

62238

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1990
20 Dec
Discontinued Application: 19546

Drug Name

DYNACIRC

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1990-12-20

19546 / 1

Active Ingredient

ISRADIPINE

Application Number

19546

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1990-12-20

Regulatory Status

Discontinued

1990
20 Dec
Discontinued Application: 19546

Drug Name

DYNACIRC

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1990-12-20

19546 / 2

Active Ingredient

ISRADIPINE

Application Number

19546

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1990-12-20

Regulatory Status

Discontinued

1994
01 Jun
Discontinued Application: 20336

Drug Name

DYNACIRC CR

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1994-06-01

20336 / 1

Active Ingredient

ISRADIPINE

Application Number

20336

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1994-06-01

Regulatory Status

Discontinued

1994
01 Jun
Discontinued Application: 20336

Drug Name

DYNACIRC CR

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1994-06-01

20336 / 2

Active Ingredient

ISRADIPINE

Application Number

20336

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1994-06-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83951

Drug Name

EMPRACET W/ CODEINE PHOSPHATE #3

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

1982-01-01

83951 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

83951

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83951

Drug Name

EMPRACET W/ CODEINE PHOSPHATE #4

Product Number

2

Dosage Form

-

Strength

300MG;60MG

Approval Date

1982-01-01

83951 / 2

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

83951

Product Number

2

Dosage Form

-

Strength

300MG;60MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1998
08 Dec
Discontinued Application: 21003

Drug Name

EPIVIR-HBV

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1998-12-08

21003 / 1

Active Ingredient

LAMIVUDINE

Application Number

21003

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1998-12-08

Regulatory Status

Discontinued

1998
08 Dec
Discontinued Application: 21004

Drug Name

EPIVIR-HBV

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1998-12-08

21004 / 1

Active Ingredient

LAMIVUDINE

Application Number

21004

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1998-12-08

Regulatory Status

Discontinued

1990
02 Aug
Discontinued Application: 20044

Drug Name

EXOSURF NEONATAL

Product Number

1

Dosage Form

-

Strength

12MG/VIAL;108MG/VIAL;8MG/VIAL

Approval Date

1990-08-02

20044 / 1

Active Ingredient

CETYL ALCOHOL; COLFOSCERIL PALMITATE; TYLOXAPOL

Application Number

20044

Product Number

1

Dosage Form

-

Strength

12MG/VIAL;108MG/VIAL;8MG/VIAL

Approval Date

1990-08-02

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17352

Drug Name

FASTIN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

17352 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

17352

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1995
20 Sep
Discontinued Application: 20444

Drug Name

FLOLAN

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE/VIAL

Approval Date

1995-09-20

20444 / 1

Active Ingredient

EPOPROSTENOL SODIUM

Application Number

20444

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE/VIAL

Approval Date

1995-09-20

Regulatory Status

Discontinued

1995
20 Sep
Discontinued Application: 20444

Drug Name

FLOLAN

Product Number

2

Dosage Form

-

Strength

EQ 1.5MG BASE/VIAL

Approval Date

1995-09-20

20444 / 2

Active Ingredient

EPOPROSTENOL SODIUM

Application Number

20444

Product Number

2

Dosage Form

-

Strength

EQ 1.5MG BASE/VIAL

Approval Date

1995-09-20

Regulatory Status

Discontinued

1996
27 Mar
Discontinued Application: 20548

Drug Name

FLOVENT

Product Number

1

Dosage Form

-

Strength

0.044MG/INH

Approval Date

1996-03-27

20548 / 1

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

20548

Product Number

1

Dosage Form

-

Strength

0.044MG/INH

Approval Date

1996-03-27

Regulatory Status

Discontinued

1996
27 Mar
Discontinued Application: 20548

Drug Name

FLOVENT

Product Number

2

Dosage Form

-

Strength

0.11MG/INH

Approval Date

1996-03-27

20548 / 2

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

20548

Product Number

2

Dosage Form

-

Strength

0.11MG/INH

Approval Date

1996-03-27

Regulatory Status

Discontinued

1996
27 Mar
Discontinued Application: 20548

Drug Name

FLOVENT

Product Number

3

Dosage Form

-

Strength

0.22MG/INH

Approval Date

1996-03-27

20548 / 3

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

20548

Product Number

3

Dosage Form

-

Strength

0.22MG/INH

Approval Date

1996-03-27

Regulatory Status

Discontinued

1997
07 Nov
Discontinued Application: 20549

Drug Name

FLOVENT

Product Number

1

Dosage Form

-

Strength

0.044MG/INH

Approval Date

1997-11-07

20549 / 1

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

20549

Product Number

1

Dosage Form

-

Strength

0.044MG/INH

Approval Date

1997-11-07

Regulatory Status

Discontinued

1997
07 Nov
Discontinued Application: 20549

Drug Name

FLOVENT

Product Number

2

Dosage Form

-

Strength

0.088MG/INH

Approval Date

1997-11-07

20549 / 2

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

20549

Product Number

2

Dosage Form

-

Strength

0.088MG/INH

Approval Date

1997-11-07

Regulatory Status

Discontinued

1997
07 Nov
Discontinued Application: 20549

Drug Name

FLOVENT

Product Number

3

Dosage Form

-

Strength

0.22MG/INH

Approval Date

1997-11-07

20549 / 3

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

20549

Product Number

3

Dosage Form

-

Strength

0.22MG/INH

Approval Date

1997-11-07

Regulatory Status

Discontinued

1992
24 Jul
Discontinued Application: 20250

Drug Name

HALFAN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1992-07-24

20250 / 1

Active Ingredient

HALOFANTRINE HYDROCHLORIDE

Application Number

20250

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1992-07-24

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11945

Drug Name

HISPRIL

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

11945 / 1

Active Ingredient

DIPHENYLPYRALINE HYDROCHLORIDE

Application Number

11945

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1992
28 Dec
Discontinued Application: 20080

Drug Name

IMITREX

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-12-28

20080 / 1

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

20080

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-12-28

Regulatory Status

Discontinued

1997
26 Aug
Discontinued Application: 20626

Drug Name

IMITREX

Product Number

2

Dosage Form

-

Strength

10MG/SPRAY

Approval Date

1997-08-26

20626 / 2

Active Ingredient

SUMATRIPTAN

Application Number

20626

Product Number

2

Dosage Form

-

Strength

10MG/SPRAY

Approval Date

1997-08-26

Regulatory Status

Discontinued

2023
01 Feb
Discontinued Application: 216951

Drug Name

JESDUVROQ

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2023-02-01

216951 / 1

Active Ingredient

DAPRODUSTAT

Application Number

216951

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2023-02-01

Regulatory Status

Discontinued

2023
01 Feb
Discontinued Application: 216951

Drug Name

JESDUVROQ

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2023-02-01

216951 / 2

Active Ingredient

DAPRODUSTAT

Application Number

216951

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2023-02-01

Regulatory Status

Discontinued

2023
01 Feb
Discontinued Application: 216951

Drug Name

JESDUVROQ

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2023-02-01

216951 / 3

Active Ingredient

DAPRODUSTAT

Application Number

216951

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2023-02-01

Regulatory Status

Discontinued

2023
01 Feb
Discontinued Application: 216951

Drug Name

JESDUVROQ

Product Number

4

Dosage Form

-

Strength

6MG

Approval Date

2023-02-01

216951 / 4

Active Ingredient

DAPRODUSTAT

Application Number

216951

Product Number

4

Dosage Form

-

Strength

6MG

Approval Date

2023-02-01

Regulatory Status

Discontinued

2023
01 Feb
Discontinued Application: 216951

Drug Name

JESDUVROQ

Product Number

5

Dosage Form

-

Strength

8MG

Approval Date

2023-02-01

216951 / 5

Active Ingredient

DAPRODUSTAT

Application Number

216951

Product Number

5

Dosage Form

-

Strength

8MG

Approval Date

2023-02-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 6309

Drug Name

KWELL

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Active Ingredient

LINDANE

Application Number

6309

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 6309

Drug Name

KWELL

Product Number

3

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Active Ingredient

LINDANE

Application Number

6309

Product Number

3

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10718

Drug Name

KWELL

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

10718 / 1

Active Ingredient

LINDANE

Application Number

10718

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84218

Drug Name

KWELL

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

84218 / 1

Active Ingredient

LINDANE

Application Number

84218

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84218

Drug Name

KWELL

Product Number

2

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

84218 / 2

Active Ingredient

LINDANE

Application Number

84218

Product Number

2

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84219

Drug Name

KWELL

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

84219 / 1

Active Ingredient

LINDANE

Application Number

84219

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1994
27 Dec
Discontinued Application: 20241

Drug Name

LAMICTAL

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1994-12-27

20241 / 4

Active Ingredient

LAMOTRIGINE

Application Number

20241

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1994-12-27

Regulatory Status

Discontinued

1994
27 Dec
Discontinued Application: 20241

Drug Name

LAMICTAL

Product Number

6

Dosage Form

-

Strength

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

Approval Date

1994-12-27

20241 / 6

Active Ingredient

LAMOTRIGINE

Application Number

20241

Product Number

6

Dosage Form

-

Strength

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

Approval Date

1994-12-27

Regulatory Status

Discontinued

1998
24 Aug
Discontinued Application: 20764

Drug Name

LAMICTAL CD

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

1998-08-24

20764 / 3

Active Ingredient

LAMOTRIGINE

Application Number

20764

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

1998-08-24

Regulatory Status

Discontinued

1982
26 Jul
Discontinued Application: 18118

Drug Name

LANOXICAPS

Product Number

1

Dosage Form

-

Strength

0.2MG

Approval Date

1982-07-26

18118 / 1

Active Ingredient

DIGOXIN

Application Number

18118

Product Number

1

Dosage Form

-

Strength

0.2MG

Approval Date

1982-07-26

Regulatory Status

Discontinued

1982
26 Jul
Discontinued Application: 18118

Drug Name

LANOXICAPS

Product Number

2

Dosage Form

-

Strength

0.05MG

Approval Date

1982-07-26

18118 / 2

Active Ingredient

DIGOXIN

Application Number

18118

Product Number

2

Dosage Form

-

Strength

0.05MG

Approval Date

1982-07-26

Regulatory Status

Discontinued

1982
26 Jul
Discontinued Application: 18118

Drug Name

LANOXICAPS

Product Number

3

Dosage Form

-

Strength

0.1MG

Approval Date

1982-07-26

18118 / 3

Active Ingredient

DIGOXIN

Application Number

18118

Product Number

3

Dosage Form

-

Strength

0.1MG

Approval Date

1982-07-26

Regulatory Status

Discontinued

1984
24 Sep
Discontinued Application: 18118

Drug Name

LANOXICAPS

Product Number

4

Dosage Form

-

Strength

0.15MG

Approval Date

1984-09-24

18118 / 4

Active Ingredient

DIGOXIN

Application Number

18118

Product Number

4

Dosage Form

-

Strength

0.15MG

Approval Date

1984-09-24

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50460

Drug Name

LAROTID

Product Number

6

Dosage Form

-

Strength

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

Approval Date

1982-01-01

50460 / 6

Active Ingredient

AMOXICILLIN

Application Number

50460

Product Number

6

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

2003
10 Feb
Discontinued Application: 75822

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2003-02-10

75822 / 1

Active Ingredient

LORATADINE

Application Number

75822

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2003-02-10

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9495

Drug Name

MAREZINE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

Active Ingredient

CYCLIZINE LACTATE

Application Number

9495

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1992
25 Nov
Discontinued Application: 20259

Drug Name

MEPRON

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1992-11-25

20259 / 1

Active Ingredient

ATOVAQUONE

Application Number

20259

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1992-11-25

Regulatory Status

Discontinued

1984
23 May
Discontinued Application: 50579

Drug Name

MONOCID

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1984-05-23

50579 / 1

Active Ingredient

CEFONICID SODIUM

Application Number

50579

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1984-05-23

Regulatory Status

Discontinued

1984
23 May
Discontinued Application: 50579

Drug Name

MONOCID

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1984-05-23

50579 / 2

Active Ingredient

CEFONICID SODIUM

Application Number

50579

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1984-05-23

Regulatory Status

Discontinued

1984
23 May
Discontinued Application: 50579

Drug Name

MONOCID

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1984-05-23

50579 / 3

Active Ingredient

CEFONICID SODIUM

Application Number

50579

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1984-05-23

Regulatory Status

Discontinued

1984
23 May
Discontinued Application: 50579

Drug Name

MONOCID

Product Number

4

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1984-05-23

50579 / 4

Active Ingredient

CEFONICID SODIUM

Application Number

50579

Product Number

4

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1984-05-23

Regulatory Status

Discontinued

1993
26 Jul
Discontinued Application: 63295

Drug Name

MONOCID

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1993-07-26

63295 / 1

Active Ingredient

CEFONICID SODIUM

Application Number

63295

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1993-07-26

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61999

Drug Name

NALLPEN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1982-01-01

61999 / 1

Active Ingredient

NAFCILLIN SODIUM

Application Number

61999

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61999

Drug Name

NALLPEN

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

61999 / 2

Active Ingredient

NAFCILLIN SODIUM

Application Number

61999

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61999

Drug Name

NALLPEN

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1982-01-01

61999 / 3

Active Ingredient

NAFCILLIN SODIUM

Application Number

61999

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61999

Drug Name

NALLPEN

Product Number

4

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1982-01-01

61999 / 4

Active Ingredient

NAFCILLIN SODIUM

Application Number

61999

Product Number

4

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1986
19 Dec
Discontinued Application: 62755

Drug Name

NALLPEN

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1986-12-19

62755 / 1

Active Ingredient

NAFCILLIN SODIUM

Application Number

62755

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1986-12-19

Regulatory Status

Discontinued

1986
19 Dec
Discontinued Application: 62755

Drug Name

NALLPEN

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1986-12-19

62755 / 2

Active Ingredient

NAFCILLIN SODIUM

Application Number

62755

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1986-12-19

Regulatory Status

Discontinued

1985
14 Jan
Discontinued Application: 50176

Drug Name

NEOSPORIN

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1985-01-14

50176 / 2

Active Ingredient

NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

50176

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1985-01-14

Regulatory Status

Discontinued

1986
31 Mar
Discontinued Application: 19435

Drug Name

NIX

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1986-03-31

19435 / 1

Active Ingredient

PERMETHRIN

Application Number

19435

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1986-03-31

Regulatory Status

Discontinued

1995
07 Nov
Discontinued Application: 63322

Drug Name

PENTACEF

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1995-11-07

63322 / 1

Active Ingredient

CEFTAZIDIME

Application Number

63322

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1995-11-07

Regulatory Status

Discontinued

1995
07 Nov
Discontinued Application: 63322

Drug Name

PENTACEF

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

1995-11-07

63322 / 2

Active Ingredient

CEFTAZIDIME

Application Number

63322

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

1995-11-07

Regulatory Status

Discontinued

1992
31 Mar
Discontinued Application: 64006

Drug Name

PENTACEF

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1992-03-31

64006 / 1

Active Ingredient

CEFTAZIDIME

Application Number

64006

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1992-03-31

Regulatory Status

Discontinued

1992
31 Mar
Discontinued Application: 64006

Drug Name

PENTACEF

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

1992-03-31

64006 / 2

Active Ingredient

CEFTAZIDIME

Application Number

64006

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

1992-03-31

Regulatory Status

Discontinued

1992
31 Mar
Discontinued Application: 64008

Drug Name

PENTACEF

Product Number

1

Dosage Form

-

Strength

6GM/VIAL

Approval Date

1992-03-31

64008 / 1

Active Ingredient

CEFTAZIDIME

Application Number

64008

Product Number

1

Dosage Form

-

Strength

6GM/VIAL

Approval Date

1992-03-31

Regulatory Status

Discontinued

1992
31 Mar
Discontinued Application: 64008

Drug Name

PENTACEF

Product Number

2

Dosage Form

-

Strength

10GM/VIAL

Approval Date

1992-03-31

64008 / 2

Active Ingredient

CEFTAZIDIME

Application Number

64008

Product Number

2

Dosage Form

-

Strength

10GM/VIAL

Approval Date

1992-03-31

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84060

Drug Name

PHYTONADIONE

Product Number

1

Dosage Form

-

Strength

1MG/0.5ML

Approval Date

1982-01-01

84060 / 1

Active Ingredient

PHYTONADIONE

Application Number

84060

Product Number

1

Dosage Form

-

Strength

1MG/0.5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84060

Drug Name

PHYTONADIONE

Product Number

2

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-01-01

84060 / 2

Active Ingredient

PHYTONADIONE

Application Number

84060

Product Number

2

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985
01 Mar
Discontinued Application: 50167

Drug Name

POLYSPORIN

Product Number

2

Dosage Form

-

Strength

10,000 UNITS/GM;2,000,000 UNITS/GM

Approval Date

1985-03-01

50167 / 2

Active Ingredient

BACITRACIN ZINC; POLYMYXIN B SULFATE

Application Number

50167

Product Number

2

Dosage Form

-

Strength

10,000 UNITS/GM;2,000,000 UNITS/GM

Approval Date

1985-03-01

Regulatory Status

Discontinued

2011
10 Jun
Discontinued Application: 22345

Drug Name

POTIGA

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2011-06-10

22345 / 1

Active Ingredient

EZOGABINE

Application Number

22345

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2011-06-10

Regulatory Status

Discontinued

2011
10 Jun
Discontinued Application: 22345

Drug Name

POTIGA

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2011-06-10

22345 / 2

Active Ingredient

EZOGABINE

Application Number

22345

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2011-06-10

Regulatory Status

Discontinued

2011
10 Jun
Discontinued Application: 22345

Drug Name

POTIGA

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2011-06-10

22345 / 3

Active Ingredient

EZOGABINE

Application Number

22345

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2011-06-10

Regulatory Status

Discontinued

2011
10 Jun
Discontinued Application: 22345

Drug Name

POTIGA

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

2011-06-10

22345 / 4

Active Ingredient

EZOGABINE

Application Number

22345

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

2011-06-10

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50298

Drug Name

PYOPEN

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

50298 / 1

Active Ingredient

CARBENICILLIN DISODIUM

Application Number

50298

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50298

Drug Name

PYOPEN

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1982-01-01

50298 / 2

Active Ingredient

CARBENICILLIN DISODIUM

Application Number

50298

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50298

Drug Name

PYOPEN

Product Number

3

Dosage Form

-

Strength

EQ 5GM BASE/VIAL

Approval Date

1982-01-01

50298 / 3

Active Ingredient

CARBENICILLIN DISODIUM

Application Number

50298

Product Number

3

Dosage Form

-

Strength

EQ 5GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50298

Drug Name

PYOPEN

Product Number

6

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1982-01-01

50298 / 6

Active Ingredient

CARBENICILLIN DISODIUM

Application Number

50298

Product Number

6

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50298

Drug Name

PYOPEN

Product Number

7

Dosage Form

-

Strength

EQ 20GM BASE/VIAL

Approval Date

1982-01-01

50298 / 7

Active Ingredient

CARBENICILLIN DISODIUM

Application Number

50298

Product Number

7

Dosage Form

-

Strength

EQ 20GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1991
24 Dec
Discontinued Application: 19583

Drug Name

RELAFEN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1991-12-24

19583 / 1

Active Ingredient

NABUMETONE

Application Number

19583

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1991-12-24

Regulatory Status

Discontinued

1991
24 Dec
Discontinued Application: 19583

Drug Name

RELAFEN

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1991-12-24

19583 / 2

Active Ingredient

NABUMETONE

Application Number

19583

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1991-12-24

Regulatory Status

Discontinued

1997
19 Sep
Discontinued Application: 20658

Drug Name

REQUIP

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1997-09-19

20658 / 1

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

20658

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1997-09-19

Regulatory Status

Discontinued

1997
19 Sep
Discontinued Application: 20658

Drug Name

REQUIP

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1997-09-19

20658 / 2

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

20658

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1997-09-19

Regulatory Status

Discontinued

1997
19 Sep
Discontinued Application: 20658

Drug Name

REQUIP

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1997-09-19

20658 / 3

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

20658

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1997-09-19

Regulatory Status

Discontinued

1997
19 Sep
Discontinued Application: 20658

Drug Name

REQUIP

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1997-09-19

20658 / 4

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

20658

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1997-09-19

Regulatory Status

Discontinued

1997
19 Sep
Discontinued Application: 20658

Drug Name

REQUIP

Product Number

5

Dosage Form

-

Strength

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

Approval Date

1997-09-19

20658 / 5

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

20658

Product Number

5

Dosage Form

-

Strength

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

Approval Date

1997-09-19

Regulatory Status

Discontinued

1999
27 Jan
Discontinued Application: 20658

Drug Name

REQUIP

Product Number

6

Dosage Form

-

Strength

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

Approval Date

1999-01-27

20658 / 6

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

20658

Product Number

6

Dosage Form

-

Strength

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

Approval Date

1999-01-27

Regulatory Status

Discontinued

1999
27 Jan
Discontinued Application: 20658

Drug Name

REQUIP

Product Number

7

Dosage Form

-

Strength

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

Approval Date

1999-01-27

20658 / 7

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

20658

Product Number

7

Dosage Form

-

Strength

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

Approval Date

1999-01-27

Regulatory Status

Discontinued

2008
13 Jun
Discontinued Application: 22008

Drug Name

REQUIP XL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2008-06-13

22008 / 1

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

22008

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2008-06-13

Regulatory Status

Discontinued

2008
13 Jun
Discontinued Application: 22008

Drug Name

REQUIP XL

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2008-06-13

22008 / 2

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

22008

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2008-06-13

Regulatory Status

Discontinued

2008
13 Jun
Discontinued Application: 22008

Drug Name

REQUIP XL

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2008-06-13

22008 / 3

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

22008

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2008-06-13

Regulatory Status

Discontinued

2008
13 Jun
Discontinued Application: 22008

Drug Name

REQUIP XL

Product Number

4

Dosage Form

-

Strength

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

Approval Date

2008-06-13

22008 / 4

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

22008

Product Number

4

Dosage Form

-

Strength

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

Approval Date

2008-06-13

Regulatory Status

Discontinued

2008
31 Oct
Discontinued Application: 22008

Drug Name

REQUIP XL

Product Number

5

Dosage Form

-

Strength

EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-10-31

22008 / 5

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

22008

Product Number

5

Dosage Form

-

Strength

EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-10-31

Regulatory Status

Discontinued

2009
10 Apr
Discontinued Application: 22008

Drug Name

REQUIP XL

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

2009-04-10

22008 / 6

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

22008

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

2009-04-10

Regulatory Status

Discontinued

1989
27 Nov
Discontinued Application: 19151

Drug Name

RYTHMOL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1989-11-27

19151 / 1

Active Ingredient

PROPAFENONE HYDROCHLORIDE

Application Number

19151

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1989-11-27

Regulatory Status

Discontinued

1989
27 Nov
Discontinued Application: 19151

Drug Name

RYTHMOL

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1989-11-27

19151 / 2

Active Ingredient

PROPAFENONE HYDROCHLORIDE

Application Number

19151

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1989-11-27

Regulatory Status

Discontinued

1992
20 Nov
Discontinued Application: 19151

Drug Name

RYTHMOL

Product Number

3

Dosage Form

-

Strength

225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-11-20

19151 / 3

Active Ingredient

PROPAFENONE HYDROCHLORIDE

Application Number

19151

Product Number

3

Dosage Form

-

Strength

225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-11-20

Regulatory Status

Discontinued

2003
04 Sep
Discontinued Application: 21416

Drug Name

RYTHMOL SR

Product Number

1

Dosage Form

-

Strength

225MG

Approval Date

2003-09-04

21416 / 1

Active Ingredient

PROPAFENONE HYDROCHLORIDE

Application Number

21416

Product Number

1

Dosage Form

-

Strength

225MG

Approval Date

2003-09-04

Regulatory Status

Discontinued

2003
04 Sep
Discontinued Application: 21416

Drug Name

RYTHMOL SR

Product Number

2

Dosage Form

-

Strength

325MG

Approval Date

2003-09-04

21416 / 2

Active Ingredient

PROPAFENONE HYDROCHLORIDE

Application Number

21416

Product Number

2

Dosage Form

-

Strength

325MG

Approval Date

2003-09-04

Regulatory Status

Discontinued

2003
04 Sep
Discontinued Application: 21416

Drug Name

RYTHMOL SR

Product Number

3

Dosage Form

-

Strength

425MG

Approval Date

2003-09-04

21416 / 3

Active Ingredient

PROPAFENONE HYDROCHLORIDE

Application Number

21416

Product Number

3

Dosage Form

-

Strength

425MG

Approval Date

2003-09-04

Regulatory Status

Discontinued

1983
15 Nov
Discontinued Application: 62435

Drug Name

SEFFIN

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1983-11-15

62435 / 1

Active Ingredient

CEPHALOTHIN SODIUM

Application Number

62435

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1983-11-15

Regulatory Status

Discontinued

1983
15 Nov
Discontinued Application: 62435

Drug Name

SEFFIN

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1983-11-15

62435 / 2

Active Ingredient

CEPHALOTHIN SODIUM

Application Number

62435

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1983-11-15

Regulatory Status

Discontinued

1983
15 Nov
Discontinued Application: 62435

Drug Name

SEFFIN

Product Number

3

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1983-11-15

62435 / 3

Active Ingredient

CEPHALOTHIN SODIUM

Application Number

62435

Product Number

3

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1983-11-15

Regulatory Status

Discontinued

1994
04 Feb
Discontinued Application: 20236

Drug Name

SEREVENT

Product Number

1

Dosage Form

-

Strength

EQ 0.021MG BASE/INH

Approval Date

1994-02-04

20236 / 1

Active Ingredient

SALMETEROL XINAFOATE

Application Number

20236

Product Number

1

Dosage Form

-

Strength

EQ 0.021MG BASE/INH

Approval Date

1994-02-04

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11552

Drug Name

STELAZINE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11552 / 1

Active Ingredient

TRIFLUOPERAZINE HYDROCHLORIDE

Application Number

11552

Product Number

1

Dosage Form

-

Strength

EQ 1MG 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: 11552

Drug Name

STELAZINE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11552 / 2

Active Ingredient

TRIFLUOPERAZINE HYDROCHLORIDE

Application Number

11552

Product Number

2

Dosage Form

-

Strength

EQ 2MG 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: 11552

Drug Name

STELAZINE

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11552 / 3

Active Ingredient

TRIFLUOPERAZINE HYDROCHLORIDE

Application Number

11552

Product Number

3

Dosage Form

-

Strength

EQ 5MG 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: 11552

Drug Name

STELAZINE

Product Number

4

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

11552 / 4

Active Ingredient

TRIFLUOPERAZINE HYDROCHLORIDE

Application Number

11552

Product Number

4

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: 11552

Drug Name

STELAZINE

Product Number

5

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11552 / 5

Active Ingredient

TRIFLUOPERAZINE HYDROCHLORIDE

Application Number

11552

Product Number

5

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11552

Drug Name

STELAZINE

Product Number

6

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11552 / 6

Active Ingredient

TRIFLUOPERAZINE HYDROCHLORIDE

Application Number

11552

Product Number

6

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 13934

Drug Name

STOXIL

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

13934 / 1

Active Ingredient

IDOXURIDINE

Application Number

13934

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 15868

Drug Name

STOXIL

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

15868 / 1

Active Ingredient

IDOXURIDINE

Application Number

15868

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17941

Drug Name

SUDAFED 12 HOUR

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

17941 / 2

Active Ingredient

PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

17941

Product Number

2

Dosage Form

-

Strength

120MG **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: 6931

Drug Name

SYNCURINE

Product Number

2

Dosage Form

-

Strength

1MG/ML

Approval Date

1982-01-01

Active Ingredient

DECAMETHONIUM BROMIDE

Application Number

6931

Product Number

2

Dosage Form

-

Strength

1MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17920

Drug Name

TAGAMET

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

17920 / 2

Active Ingredient

CIMETIDINE

Application Number

17920

Product Number

2

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: 17920

Drug Name

TAGAMET

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

17920 / 3

Active Ingredient

CIMETIDINE

Application Number

17920

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1983
14 Dec
Discontinued Application: 17920

Drug Name

TAGAMET

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1983-12-14

17920 / 4

Active Ingredient

CIMETIDINE

Application Number

17920

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1983-12-14

Regulatory Status

Discontinued

1986
30 Apr
Discontinued Application: 17920

Drug Name

TAGAMET

Product Number

5

Dosage Form

-

Strength

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

Approval Date

1986-04-30

17920 / 5

Active Ingredient

CIMETIDINE

Application Number

17920

Product Number

5

Dosage Form

-

Strength

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

Approval Date

1986-04-30

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17924

Drug Name

TAGAMET

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17924 / 1

Active Ingredient

CIMETIDINE HYDROCHLORIDE

Application Number

17924

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/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: 17939

Drug Name

TAGAMET

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE/2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17939 / 2

Active Ingredient

CIMETIDINE HYDROCHLORIDE

Application Number

17939

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE/2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1999
09 Jul
Discontinued Application: 20951

Drug Name

TAGAMET HB 200

Product Number

1

Dosage Form

-

Strength

200MG/20ML

Approval Date

1999-07-09

20951 / 1

Active Ingredient

CIMETIDINE

Application Number

20951

Product Number

1

Dosage Form

-

Strength

200MG/20ML

Approval Date

1999-07-09

Regulatory Status

Discontinued

1985
31 Oct
Discontinued Application: 19434

Drug Name

TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1985-10-31

19434 / 1

Active Ingredient

CIMETIDINE HYDROCHLORIDE

Application Number

19434

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1985-10-31

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17369

Drug Name

TELDRIN

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

1982-01-01

17369 / 1

Active Ingredient

CHLORPHENIRAMINE MALEATE

Application Number

17369

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17369

Drug Name

TELDRIN

Product Number

2

Dosage Form

-

Strength

12MG

Approval Date

1982-01-01

17369 / 2

Active Ingredient

CHLORPHENIRAMINE MALEATE

Application Number

17369

Product Number

2

Dosage Form

-

Strength

12MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9149

Drug Name

THORAZINE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

9149

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9149

Drug Name

THORAZINE

Product Number

7

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

CHLORPROMAZINE HYDROCHLORIDE

Application Number

9149

Product Number

7

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: 9149

Drug Name

THORAZINE

Product Number

11

Dosage Form

-

Strength

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

Approval Date

1982-01-01

9149 / 11

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

9149

Product Number

11

Dosage Form

-

Strength

25MG/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: 9149

Drug Name

THORAZINE

Product Number

13

Dosage Form

-

Strength

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

Approval Date

1982-01-01

9149 / 13

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

9149

Product Number

13

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: 9149

Drug Name

THORAZINE

Product Number

18

Dosage Form

-

Strength

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

Approval Date

1982-01-01

9149 / 18

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

9149

Product Number

18

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: 9149

Drug Name

THORAZINE

Product Number

20

Dosage Form

-

Strength

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

Approval Date

1982-01-01

9149 / 20

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

9149

Product Number

20

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: 9149

Drug Name

THORAZINE

Product Number

22

Dosage Form

-

Strength

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

Approval Date

1982-01-01

9149 / 22

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

9149

Product Number

22

Dosage Form

-

Strength

10MG/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: 9149

Drug Name

THORAZINE

Product Number

24

Dosage Form

-

Strength

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

Approval Date

1982-01-01

9149 / 24

Active Ingredient

CHLORPROMAZINE

Application Number

9149

Product Number

24

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: 9149

Drug Name

THORAZINE

Product Number

32

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

9149 / 32

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

9149

Product Number

32

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: 9149

Drug Name

THORAZINE

Product Number

33

Dosage Form

-

Strength

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

Approval Date

1982-01-01

9149 / 33

Active Ingredient

CHLORPROMAZINE

Application Number

9149

Product Number

33

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: 9149

Drug Name

THORAZINE

Product Number

43

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

9149 / 43

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

9149

Product Number

43

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: 11120

Drug Name

THORAZINE

Product Number

16

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

11120 / 16

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

11120

Product Number

16

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11120

Drug Name

THORAZINE

Product Number

17

Dosage Form

-

Strength

75MG

Approval Date

1982-01-01

11120 / 17

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

11120

Product Number

17

Dosage Form

-

Strength

75MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11120

Drug Name

THORAZINE

Product Number

18

Dosage Form

-

Strength

150MG

Approval Date

1982-01-01

11120 / 18

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

11120

Product Number

18

Dosage Form

-

Strength

150MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11120

Drug Name

THORAZINE

Product Number

19

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

11120 / 19

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

11120

Product Number

19

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11120

Drug Name

THORAZINE

Product Number

20

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

11120 / 20

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

11120

Product Number

20

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2007
19 Jun
Discontinued Application: 77656

Drug Name

THRIVE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2007-06-19

77656 / 1

Active Ingredient

NICOTINE POLACRILEX

Application Number

77656

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2007-06-19

Regulatory Status

Discontinued

2007
19 Jun
Discontinued Application: 77658

Drug Name

THRIVE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2007-06-19

77658 / 1

Active Ingredient

NICOTINE POLACRILEX

Application Number

77658

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2007-06-19

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50497

Drug Name

TICAR

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

50497 / 1

Active Ingredient

TICARCILLIN DISODIUM

Application Number

50497

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50497

Drug Name

TICAR

Product Number

2

Dosage Form

-

Strength

EQ 3GM BASE/VIAL

Approval Date

1982-01-01

50497 / 2

Active Ingredient

TICARCILLIN DISODIUM

Application Number

50497

Product Number

2

Dosage Form

-

Strength

EQ 3GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50497

Drug Name

TICAR

Product Number

3

Dosage Form

-

Strength

EQ 6GM BASE/VIAL

Approval Date

1982-01-01

50497 / 3

Active Ingredient

TICARCILLIN DISODIUM

Application Number

50497

Product Number

3

Dosage Form

-

Strength

EQ 6GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50497

Drug Name

TICAR

Product Number

4

Dosage Form

-

Strength

EQ 20GM BASE/VIAL

Approval Date

1982-01-01

50497 / 4

Active Ingredient

TICARCILLIN DISODIUM

Application Number

50497

Product Number

4

Dosage Form

-

Strength

EQ 20GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
04 Apr
Discontinued Application: 50497

Drug Name

TICAR

Product Number

5

Dosage Form

-

Strength

EQ 30GM BASE/VIAL

Approval Date

1984-04-04

50497 / 5

Active Ingredient

TICARCILLIN DISODIUM

Application Number

50497

Product Number

5

Dosage Form

-

Strength

EQ 30GM BASE/VIAL

Approval Date

1984-04-04

Regulatory Status

Discontinued

1986
19 Dec
Discontinued Application: 62690

Drug Name

TICAR

Product Number

1

Dosage Form

-

Strength

EQ 3GM BASE/VIAL

Approval Date

1986-12-19

62690 / 1

Active Ingredient

TICARCILLIN DISODIUM

Application Number

62690

Product Number

1

Dosage Form

-

Strength

EQ 3GM BASE/VIAL

Approval Date

1986-12-19

Regulatory Status

Discontinued

1985
01 Apr
Discontinued Application: 50590

Drug Name

TIMENTIN

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL

Approval Date

1985-04-01

50590 / 1

Active Ingredient

CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM

Application Number

50590

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL

Approval Date

1985-04-01

Regulatory Status

Discontinued

1985
01 Apr
Discontinued Application: 50590

Drug Name

TIMENTIN

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE/VIAL;EQ 3GM BASE/VIAL

Approval Date

1985-04-01

50590 / 2

Active Ingredient

CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM

Application Number

50590

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE/VIAL;EQ 3GM BASE/VIAL

Approval Date

1985-04-01

Regulatory Status

Discontinued

1987
18 Aug
Discontinued Application: 50590

Drug Name

TIMENTIN

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL;EQ 30GM BASE/VIAL

Approval Date

1987-08-18

50590 / 3

Active Ingredient

CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM

Application Number

50590

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL;EQ 30GM BASE/VIAL

Approval Date

1987-08-18

Regulatory Status

Discontinued

1986
19 Dec
Discontinued Application: 62691

Drug Name

TIMENTIN

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL

Approval Date

1986-12-19

62691 / 1

Active Ingredient

CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM

Application Number

62691

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL

Approval Date

1986-12-19

Regulatory Status

Discontinued

1989
15 Dec
Discontinued Application: 50658

Drug Name

TIMENTIN IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/100ML;EQ 3GM BASE/100ML

Approval Date

1989-12-15

50658 / 1

Active Ingredient

CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM

Application Number

50658

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/100ML;EQ 3GM BASE/100ML

Approval Date

1989-12-15

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60060

Drug Name

TOTACILLIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

60060 / 1

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

60060

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60060

Drug Name

TOTACILLIN

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

60060 / 2

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

60060

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60666

Drug Name

TOTACILLIN

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

60666 / 1

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

60666

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60666

Drug Name

TOTACILLIN

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

60666 / 2

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

60666

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62212

Drug Name

TOTACILLIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

62212 / 1

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

62212

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62212

Drug Name

TOTACILLIN

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

62212 / 2

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

62212

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62223

Drug Name

TOTACILLIN

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

62223 / 1

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

62223

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62223

Drug Name

TOTACILLIN

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

62223 / 2

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

62223

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60677

Drug Name

TOTACILLIN-N

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/VIAL

Approval Date

1982-01-01

60677 / 1

Active Ingredient

AMPICILLIN SODIUM

Application Number

60677

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60677

Drug Name

TOTACILLIN-N

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1982-01-01

60677 / 2

Active Ingredient

AMPICILLIN SODIUM

Application Number

60677

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60677

Drug Name

TOTACILLIN-N

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1982-01-01

60677 / 3

Active Ingredient

AMPICILLIN SODIUM

Application Number

60677

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60677

Drug Name

TOTACILLIN-N

Product Number

4

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

60677 / 4

Active Ingredient

AMPICILLIN SODIUM

Application Number

60677

Product Number

4

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60677

Drug Name

TOTACILLIN-N

Product Number

5

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1982-01-01

60677 / 5

Active Ingredient

AMPICILLIN SODIUM

Application Number

60677

Product Number

5

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60677

Drug Name

TOTACILLIN-N

Product Number

6

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1982-01-01

60677 / 6

Active Ingredient

AMPICILLIN SODIUM

Application Number

60677

Product Number

6

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1986
19 Dec
Discontinued Application: 62727

Drug Name

TOTACILLIN-N

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1986-12-19

62727 / 1

Active Ingredient

AMPICILLIN SODIUM

Application Number

62727

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1986-12-19

Regulatory Status

Discontinued

1986
19 Dec
Discontinued Application: 62727

Drug Name

TOTACILLIN-N

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1986-12-19

62727 / 2

Active Ingredient

AMPICILLIN SODIUM

Application Number

62727

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1986-12-19

Regulatory Status

Discontinued

1987
10 Apr
Discontinued Application: 19174

Drug Name

TRANDATE HCT

Product Number

1

Dosage Form

-

Strength

25MG;100MG

Approval Date

1987-04-10

19174 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

Application Number

19174

Product Number

1

Dosage Form

-

Strength

25MG;100MG

Approval Date

1987-04-10

Regulatory Status

Discontinued

1987
10 Apr
Discontinued Application: 19174

Drug Name

TRANDATE HCT

Product Number

2

Dosage Form

-

Strength

25MG;200MG

Approval Date

1987-04-10

19174 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

Application Number

19174

Product Number

2

Dosage Form

-

Strength

25MG;200MG

Approval Date

1987-04-10

Regulatory Status

Discontinued

1987
10 Apr
Discontinued Application: 19174

Drug Name

TRANDATE HCT

Product Number

3

Dosage Form

-

Strength

25MG;300MG

Approval Date

1987-04-10

19174 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

Application Number

19174

Product Number

3

Dosage Form

-

Strength

25MG;300MG

Approval Date

1987-04-10

Regulatory Status

Discontinued

1987
10 Apr
Discontinued Application: 19174

Drug Name

TRANDATE HCT

Product Number

4

Dosage Form

-

Strength

25MG;400MG

Approval Date

1987-04-10

19174 / 4

Active Ingredient

HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

Application Number

19174

Product Number

4

Dosage Form

-

Strength

25MG;400MG

Approval Date

1987-04-10

Regulatory Status

Discontinued

1996
08 Aug
Discontinued Application: 20559

Drug Name

TRITEC

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1996-08-08

20559 / 1

Active Ingredient

RANITIDINE BISMUTH CITRATE

Application Number

20559

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1996-08-08

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 6772

Drug Name

VASOXYL

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1982-01-01

Active Ingredient

METHOXAMINE HYDROCHLORIDE

Application Number

6772

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 6772

Drug Name

VASOXYL

Product Number

2

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-01-01

Active Ingredient

METHOXAMINE HYDROCHLORIDE

Application Number

6772

Product Number

2

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18473

Drug Name

VENTOLIN

Product Number

1

Dosage Form

-

Strength

0.09MG/INH

Approval Date

1982-01-01

18473 / 1

Active Ingredient

ALBUTEROL

Application Number

18473

Product Number

1

Dosage Form

-

Strength

0.09MG/INH

Approval Date

1982-01-01

Regulatory Status

Discontinued

1986
10 Jul
Discontinued Application: 19112

Drug Name

VENTOLIN

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1986-07-10

19112 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

19112

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1986-07-10

Regulatory Status

Discontinued

1986
10 Jul
Discontinued Application: 19112

Drug Name

VENTOLIN

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

1986-07-10

19112 / 2

Active Ingredient

ALBUTEROL SULFATE

Application Number

19112

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

1986-07-10

Regulatory Status

Discontinued

1987
16 Jan
Discontinued Application: 19269

Drug Name

VENTOLIN

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1987-01-16

19269 / 2

Active Ingredient

ALBUTEROL SULFATE

Application Number

19269

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1987-01-16

Regulatory Status

Discontinued

1987
10 Jun
Discontinued Application: 19621

Drug Name

VENTOLIN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1987-06-10

19621 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

19621

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1987-06-10

Regulatory Status

Discontinued

1992
23 Apr
Discontinued Application: 19773

Drug Name

VENTOLIN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1992-04-23

19773 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

19773

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1992-04-23

Regulatory Status

Discontinued

1988
04 May
Discontinued Application: 19489

Drug Name

VENTOLIN ROTACAPS

Product Number

1

Dosage Form

-

Strength

EQ 0.2MG BASE

Approval Date

1988-05-04

19489 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

19489

Product Number

1

Dosage Form

-

Strength

EQ 0.2MG BASE

Approval Date

1988-05-04

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16033

Drug Name

VONTROL

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1982-01-01

16033 / 1

Active Ingredient

DIPHENIDOL HYDROCHLORIDE

Application Number

16033

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985
30 Dec
Discontinued Application: 18644

Drug Name

WELLBUTRIN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1985-12-30

18644 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

18644

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1985-12-30

Regulatory Status

Discontinued

1985
30 Dec
Discontinued Application: 18644

Drug Name

WELLBUTRIN

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1985-12-30

18644 / 2

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

18644

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1985-12-30

Regulatory Status

Discontinued

1985
30 Dec
Discontinued Application: 18644

Drug Name

WELLBUTRIN

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1985-12-30

18644 / 3

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

18644

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1985-12-30

Regulatory Status

Discontinued

1996
04 Oct
Discontinued Application: 20358

Drug Name

WELLBUTRIN SR

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1996-10-04

20358 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

20358

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1996-10-04

Regulatory Status

Discontinued

1983
08 Jul
Discontinued Application: 18342

Drug Name

WELLCOVORIN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1983-07-08

18342 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

18342

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1983-07-08

Regulatory Status

Discontinued

1983
08 Jul
Discontinued Application: 18342

Drug Name

WELLCOVORIN

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

1983-07-08

18342 / 2

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

18342

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

1983-07-08

Regulatory Status

Discontinued

1982
19 Oct
Discontinued Application: 87439

Drug Name

WELLCOVORIN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-10-19

87439 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

87439

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-10-19

Regulatory Status

Discontinued

1982
19 Oct
Discontinued Application: 87439

Drug Name

WELLCOVORIN

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE/5ML (EQ 5MG BASE/ML)

Approval Date

1982-10-19

87439 / 2

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

87439

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE/5ML (EQ 5MG BASE/ML)

Approval Date

1982-10-19

Regulatory Status

Discontinued

1989
23 Jan
Discontinued Application: 89465

Drug Name

WELLCOVORIN

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

1989-01-23

89465 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

89465

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

1989-01-23

Regulatory Status

Discontinued

1989
23 Jan
Discontinued Application: 89833

Drug Name

WELLCOVORIN

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/VIAL

Approval Date

1989-01-23

89833 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

89833

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/VIAL

Approval Date

1989-01-23

Regulatory Status

Discontinued

1989
23 Jan
Discontinued Application: 89834

Drug Name

WELLCOVORIN

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

1989-01-23

89834 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

89834

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

1989-01-23

Regulatory Status

Discontinued

1988
30 Dec
Discontinued Application: 19675

Drug Name

ZANTAC

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE/ML

Approval Date

1988-12-30

19675 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

19675

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE/ML

Approval Date

1988-12-30

Regulatory Status

Discontinued

1983
09 Jun
Discontinued Application: 18703

Drug Name

ZANTAC 150

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1983-06-09

18703 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

18703

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1983-06-09

Regulatory Status

Discontinued

1994
08 Mar
Discontinued Application: 20095

Drug Name

ZANTAC 150

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1994-03-08

20095 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

20095

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1994-03-08

Regulatory Status

Discontinued

1994
31 Mar
Discontinued Application: 20251

Drug Name

ZANTAC 150

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1994-03-31

20251 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

20251

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1994-03-31

Regulatory Status

Discontinued

1994
31 Mar
Discontinued Application: 20251

Drug Name

ZANTAC 150

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE/PACKET

Approval Date

1994-03-31

20251 / 2

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

20251

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE/PACKET

Approval Date

1994-03-31

Regulatory Status

Discontinued

2004
01 Apr
Discontinued Application: 20251

Drug Name

ZANTAC 25

Product Number

3

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2004-04-01

20251 / 3

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

20251

Product Number

3

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2004-04-01

Regulatory Status

Discontinued

1985
09 Dec
Discontinued Application: 18703

Drug Name

ZANTAC 300

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1985-12-09

18703 / 2

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

18703

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1985-12-09

Regulatory Status

Discontinued

1994
08 Mar
Discontinued Application: 20095

Drug Name

ZANTAC 300

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1994-03-08

20095 / 2

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

20095

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1994-03-08

Regulatory Status

Discontinued

2017
27 Mar
Discontinued Application: 208447

Drug Name

ZEJULA

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2017-03-27

208447 / 1

Active Ingredient

NIRAPARIB TOSYLATE

Application Number

208447

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2017-03-27

Regulatory Status

Discontinued

1995
31 Jan
Discontinued Application: 20403

Drug Name

ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 0.64MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-01-31

20403 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

20403

Product Number

1

Dosage Form

-

Strength

EQ 0.64MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-01-31

Regulatory Status

Discontinued

1982
22 Oct
Discontinued Application: 18603

Drug Name

ZOVIRAX

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-10-22

18603 / 1

Active Ingredient

ACYCLOVIR SODIUM

Application Number

18603

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-10-22

Regulatory Status

Discontinued

1989
29 Jun
Discontinued Application: 18603

Drug Name

ZOVIRAX

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1989-06-29

18603 / 2

Active Ingredient

ACYCLOVIR SODIUM

Application Number

18603

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1989-06-29

Regulatory Status

Discontinued

1983
30 Aug
Discontinued Application: 18603

Drug Name

ZOVIRAX

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1983-08-30

18603 / 3

Active Ingredient

ACYCLOVIR SODIUM

Application Number

18603

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1983-08-30

Regulatory Status

Discontinued

1997
14 May
Discontinued Application: 20711

Drug Name

ZYBAN

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1997-05-14

20711 / 2

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

20711

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1997-05-14

Regulatory Status

Discontinued

1997
14 May
Discontinued Application: 20711

Drug Name

ZYBAN

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1997-05-14

20711 / 3

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

20711

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1997-05-14

Regulatory Status

Discontinued

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Drug Status Breakdown
296 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

ACTIDIL

Application Number

11110

Product Number

2

Active Ingredient

TRIPROLIDINE HYDROCHLORIDE

Dosage Form

-

Strength

2.5MG

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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