IVAX Pharmaceuticals Inc
FDA Approved Drugs

IVAX Pharmaceuticals Inc

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 RX OTC Unclassified
  • Total Records 326
  • Latest Approval Date Sep 19, 2024
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
326
View
Unclassified
3
View
Discontinued
289
View
OTC
1
View
RX
33
View
Company Overview

Company

IVAX Pharmaceuticals Inc

Country

U.S.A

Email

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Company Snapshot

IVAX Pharmaceuticals Inc

4400 Biscayne Blvd, Miami, FL 33137

U.S.A

www.tevapharm.com/ View on Map
FDA Approved Drug Records ( 326 records )
1997
22 Apr
Discontinued Application: 74674

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-04-22

74674 / 1

Active Ingredient

ACYCLOVIR

Application Number

74674

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-04-22

Regulatory Status

Discontinued

1997
22 Apr
Discontinued Application: 74836

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1997-04-22

74836 / 1

Active Ingredient

ACYCLOVIR

Application Number

74836

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1997-04-22

Regulatory Status

Discontinued

1997
22 Apr
Discontinued Application: 74836

Drug Name

ACYCLOVIR

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

1997-04-22

74836 / 2

Active Ingredient

ACYCLOVIR

Application Number

74836

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

1997-04-22

Regulatory Status

Discontinued

1995
28 Dec
Discontinued Application: 73272

Drug Name

ALBUTEROL

Product Number

1

Dosage Form

-

Strength

0.09MG/INH

Approval Date

1995-12-28

73272 / 1

Active Ingredient

ALBUTEROL

Application Number

73272

Product Number

1

Dosage Form

-

Strength

0.09MG/INH

Approval Date

1995-12-28

Regulatory Status

Discontinued

1989
13 Jan
Discontinued Application: 89907

Drug Name

ALLAY

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1989-01-13

89907 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

89907

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1989-01-13

Regulatory Status

Discontinued

1994
29 Jul
Discontinued Application: 74294

Drug Name

ALPRAZOLAM

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

1994-07-29

74294 / 1

Active Ingredient

ALPRAZOLAM

Application Number

74294

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

1994-07-29

Regulatory Status

Discontinued

1994
29 Jul
Discontinued Application: 74294

Drug Name

ALPRAZOLAM

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1994-07-29

74294 / 2

Active Ingredient

ALPRAZOLAM

Application Number

74294

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1994-07-29

Regulatory Status

Discontinued

1994
29 Jul
Discontinued Application: 74294

Drug Name

ALPRAZOLAM

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

1994-07-29

74294 / 3

Active Ingredient

ALPRAZOLAM

Application Number

74294

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

1994-07-29

Regulatory Status

Discontinued

1994
29 Jul
Discontinued Application: 74294

Drug Name

ALPRAZOLAM

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

1994-07-29

74294 / 4

Active Ingredient

ALPRAZOLAM

Application Number

74294

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

1994-07-29

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60765

Drug Name

AMPICILLIN TRIHYDRATE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

60765 / 1

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

60765

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60765

Drug Name

AMPICILLIN TRIHYDRATE

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

60765 / 2

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

60765

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1988
21 Jul
RX Application: 72234

Drug Name

BACLOFEN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1988-07-21

72234 / 1

Active Ingredient

BACLOFEN

Application Number

72234

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1988-07-21

Regulatory Status

RX

1988
21 Jul
RX Application: 72235

Drug Name

BACLOFEN

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1988-07-21

72235 / 1

Active Ingredient

BACLOFEN

Application Number

72235

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1988-07-21

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 84689

Drug Name

BETHANECHOL CHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

84689 / 1

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

84689

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2000
27 Sep
Discontinued Application: 75632

Drug Name

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

2.5MG;6.25MG

Approval Date

2000-09-27

75632 / 1

Active Ingredient

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Application Number

75632

Product Number

1

Dosage Form

-

Strength

2.5MG;6.25MG

Approval Date

2000-09-27

Regulatory Status

Discontinued

2000
27 Sep
Discontinued Application: 75632

Drug Name

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2000-09-27

75632 / 2

Active Ingredient

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Application Number

75632

Product Number

2

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2000-09-27

Regulatory Status

Discontinued

2000
27 Sep
Discontinued Application: 75632

Drug Name

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

10MG;6.25MG

Approval Date

2000-09-27

75632 / 3

Active Ingredient

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Application Number

75632

Product Number

3

Dosage Form

-

Strength

10MG;6.25MG

Approval Date

2000-09-27

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84351

Drug Name

BROMPHENIRAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

84351 / 1

Active Ingredient

BROMPHENIRAMINE MALEATE

Application Number

84351

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2002
01 Mar
Discontinued Application: 75385

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2002-03-01

75385 / 1

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

75385

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2002-03-01

Regulatory Status

Discontinued

2002
01 Mar
Discontinued Application: 75385

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2002-03-01

75385 / 2

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

75385

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2002-03-01

Regulatory Status

Discontinued

2002
01 Mar
Discontinued Application: 75385

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2002-03-01

75385 / 3

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

75385

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2002-03-01

Regulatory Status

Discontinued

1984
31 Oct
Discontinued Application: 85441

Drug Name

BUTALBITAL, ASPIRIN AND CAFFEINE

Product Number

2

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1984-10-31

85441 / 2

Active Ingredient

ASPIRIN; BUTALBITAL; CAFFEINE

Application Number

85441

Product Number

2

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1984-10-31

Regulatory Status

Discontinued

1993
30 Jul
Discontinued Application: 62751

Drug Name

C-SOLVE-2

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1993-07-30

62751 / 1

Active Ingredient

ERYTHROMYCIN

Application Number

62751

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1993-07-30

Regulatory Status

Discontinued

2007
07 Mar
RX Application: 77750

Drug Name

CABERGOLINE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2007-03-07

77750 / 1

Active Ingredient

CABERGOLINE

Application Number

77750

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2007-03-07

Regulatory Status

RX

1998
18 Jun
Discontinued Application: 75055

Drug Name

CAPTOPRIL AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG;15MG

Approval Date

1998-06-18

75055 / 1

Active Ingredient

CAPTOPRIL; HYDROCHLOROTHIAZIDE

Application Number

75055

Product Number

1

Dosage Form

-

Strength

25MG;15MG

Approval Date

1998-06-18

Regulatory Status

Discontinued

1998
18 Jun
Discontinued Application: 75055

Drug Name

CAPTOPRIL AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

25MG;25MG

Approval Date

1998-06-18

75055 / 2

Active Ingredient

CAPTOPRIL; HYDROCHLOROTHIAZIDE

Application Number

75055

Product Number

2

Dosage Form

-

Strength

25MG;25MG

Approval Date

1998-06-18

Regulatory Status

Discontinued

1998
18 Jun
Discontinued Application: 75055

Drug Name

CAPTOPRIL AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

50MG;25MG

Approval Date

1998-06-18

75055 / 3

Active Ingredient

CAPTOPRIL; HYDROCHLOROTHIAZIDE

Application Number

75055

Product Number

3

Dosage Form

-

Strength

50MG;25MG

Approval Date

1998-06-18

Regulatory Status

Discontinued

1998
18 Jun
Discontinued Application: 75055

Drug Name

CAPTOPRIL AND HYDROCHLOROTHIAZIDE

Product Number

4

Dosage Form

-

Strength

50MG;15MG

Approval Date

1998-06-18

75055 / 4

Active Ingredient

CAPTOPRIL; HYDROCHLOROTHIAZIDE

Application Number

75055

Product Number

4

Dosage Form

-

Strength

50MG;15MG

Approval Date

1998-06-18

Regulatory Status

Discontinued

1995
27 Apr
Discontinued Application: 64061

Drug Name

CEFACLOR

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1995-04-27

64061 / 1

Active Ingredient

CEFACLOR

Application Number

64061

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1995-04-27

Regulatory Status

Discontinued

1995
27 Apr
Discontinued Application: 64061

Drug Name

CEFACLOR

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1995-04-27

64061 / 2

Active Ingredient

CEFACLOR

Application Number

64061

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1995-04-27

Regulatory Status

Discontinued

1995
28 Apr
Discontinued Application: 64070

Drug Name

CEFACLOR

Product Number

1

Dosage Form

-

Strength

EQ 375MG BASE/5ML

Approval Date

1995-04-28

64070 / 1

Active Ingredient

CEFACLOR

Application Number

64070

Product Number

1

Dosage Form

-

Strength

EQ 375MG BASE/5ML

Approval Date

1995-04-28

Regulatory Status

Discontinued

1995
28 Apr
Discontinued Application: 64085

Drug Name

CEFACLOR

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1995-04-28

64085 / 1

Active Ingredient

CEFACLOR

Application Number

64085

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1995-04-28

Regulatory Status

Discontinued

1995
28 Apr
Discontinued Application: 64086

Drug Name

CEFACLOR

Product Number

1

Dosage Form

-

Strength

EQ 187MG BASE/5ML

Approval Date

1995-04-28

64086 / 1

Active Ingredient

CEFACLOR

Application Number

64086

Product Number

1

Dosage Form

-

Strength

EQ 187MG BASE/5ML

Approval Date

1995-04-28

Regulatory Status

Discontinued

1995
28 Apr
Discontinued Application: 64087

Drug Name

CEFACLOR

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1995-04-28

64087 / 1

Active Ingredient

CEFACLOR

Application Number

64087

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1995-04-28

Regulatory Status

Discontinued

1987
03 Mar
Discontinued Application: 62766

Drug Name

CEFADROXIL

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1987-03-03

62766 / 1

Active Ingredient

CEFADROXIL/CEFADROXIL HEMIHYDRATE

Application Number

62766

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1987-03-03

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61969

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

61969 / 1

Active Ingredient

CEPHALEXIN

Application Number

61969

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61969

Drug Name

CEPHALEXIN

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

61969 / 2

Active Ingredient

CEPHALEXIN

Application Number

61969

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1987
06 Mar
Discontinued Application: 62762

Drug Name

CEPHRADINE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1987-03-06

62762 / 1

Active Ingredient

CEPHRADINE

Application Number

62762

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1987-03-06

Regulatory Status

Discontinued

1987
06 Mar
Discontinued Application: 62762

Drug Name

CEPHRADINE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1987-03-06

62762 / 2

Active Ingredient

CEPHRADINE

Application Number

62762

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1987-03-06

Regulatory Status

Discontinued

2008
25 Feb
OTC Application: 77170

Drug Name

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG;120MG

Approval Date

2008-02-25

77170 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

77170

Product Number

1

Dosage Form

-

Strength

5MG;120MG

Approval Date

2008-02-25

Regulatory Status

OTC

-
Unclassified Application: 62247

Drug Name

CHLORAMPHENICOL

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

-

62247 / 1

Active Ingredient

CHLORAMPHENICOL

Application Number

62247

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

-

Regulatory Status

Unclassified

1982
01 Jan
Discontinued Application: 83570

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

83570 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

83570

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83741

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

83741 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

83741

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83742

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

83742 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

83742

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80779

Drug Name

CHLORPHENIRAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

80779 / 1

Active Ingredient

CHLORPHENIRAMINE MALEATE

Application Number

80779

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83549

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

83549 / 1

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

83549

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83549

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

83549 / 2

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

83549

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83549

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

83549 / 3

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

83549

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83574

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

83574 / 1

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

83574

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83575

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

83575 / 1

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

83575

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87176

Drug Name

CHLORTHALIDONE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

87176 / 1

Active Ingredient

CHLORTHALIDONE

Application Number

87176

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87555

Drug Name

CHLORTHALIDONE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

87555 / 1

Active Ingredient

CHLORTHALIDONE

Application Number

87555

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
27 Feb
Discontinued Application: 87947

Drug Name

CHLORTHALIDONE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1984-02-27

87947 / 1

Active Ingredient

CHLORTHALIDONE

Application Number

87947

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1984-02-27

Regulatory Status

Discontinued

1997
09 Jul
Discontinued Application: 74771

Drug Name

CHOLESTYRAMINE

Product Number

1

Dosage Form

-

Strength

EQ 4GM RESIN/PACKET

Approval Date

1997-07-09

74771 / 1

Active Ingredient

CHOLESTYRAMINE

Application Number

74771

Product Number

1

Dosage Form

-

Strength

EQ 4GM RESIN/PACKET

Approval Date

1997-07-09

Regulatory Status

Discontinued

1997
09 Jul
Discontinued Application: 74771

Drug Name

CHOLESTYRAMINE

Product Number

2

Dosage Form

-

Strength

EQ 4GM RESIN/SCOOPFUL

Approval Date

1997-07-09

74771 / 2

Active Ingredient

CHOLESTYRAMINE

Application Number

74771

Product Number

2

Dosage Form

-

Strength

EQ 4GM RESIN/SCOOPFUL

Approval Date

1997-07-09

Regulatory Status

Discontinued

2005
01 Mar
Discontinued Application: 77020

Drug Name

CILOSTAZOL

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2005-03-01

77020 / 2

Active Ingredient

CILOSTAZOL

Application Number

77020

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2005-03-01

Regulatory Status

Discontinued

1995
30 May
Discontinued Application: 74401

Drug Name

CIMETIDINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1995-05-30

74401 / 1

Active Ingredient

CIMETIDINE

Application Number

74401

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1995-05-30

Regulatory Status

Discontinued

1995
30 May
Discontinued Application: 74401

Drug Name

CIMETIDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1995-05-30

74401 / 2

Active Ingredient

CIMETIDINE

Application Number

74401

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1995-05-30

Regulatory Status

Discontinued

1995
30 May
Discontinued Application: 74401

Drug Name

CIMETIDINE

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1995-05-30

74401 / 3

Active Ingredient

CIMETIDINE

Application Number

74401

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1995-05-30

Regulatory Status

Discontinued

1995
30 May
Discontinued Application: 74402

Drug Name

CIMETIDINE

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

1995-05-30

74402 / 1

Active Ingredient

CIMETIDINE

Application Number

74402

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

1995-05-30

Regulatory Status

Discontinued

1995
28 Jul
Discontinued Application: 74424

Drug Name

CIMETIDINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1995-07-28

74424 / 1

Active Ingredient

CIMETIDINE

Application Number

74424

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1995-07-28

Regulatory Status

Discontinued

1995
28 Jul
Discontinued Application: 74424

Drug Name

CIMETIDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1995-07-28

74424 / 2

Active Ingredient

CIMETIDINE

Application Number

74424

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1995-07-28

Regulatory Status

Discontinued

1995
28 Jul
Discontinued Application: 74424

Drug Name

CIMETIDINE

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1995-07-28

74424 / 3

Active Ingredient

CIMETIDINE

Application Number

74424

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1995-07-28

Regulatory Status

Discontinued

1995
28 Jul
Discontinued Application: 74424

Drug Name

CIMETIDINE

Product Number

4

Dosage Form

-

Strength

800MG

Approval Date

1995-07-28

74424 / 4

Active Ingredient

CIMETIDINE

Application Number

74424

Product Number

4

Dosage Form

-

Strength

800MG

Approval Date

1995-07-28

Regulatory Status

Discontinued

1999
16 Jun
Discontinued Application: 75345

Drug Name

CIMETIDINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1999-06-16

75345 / 1

Active Ingredient

CIMETIDINE

Application Number

75345

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1999-06-16

Regulatory Status

Discontinued

-
Unclassified Application: 76089

Drug Name

CIPROFLOXACIN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

-

76089 / 1

Active Ingredient

CIPROFLOXACIN

Application Number

76089

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

2004
09 Jun
RX Application: 76089

Drug Name

CIPROFLOXACIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2004-06-09

76089 / 2

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

76089

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2004-06-09

Regulatory Status

RX

2004
09 Jun
RX Application: 76089

Drug Name

CIPROFLOXACIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2004-06-09

76089 / 3

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

76089

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2004-06-09

Regulatory Status

RX

2004
09 Jun
RX Application: 76089

Drug Name

CIPROFLOXACIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2004-06-09

76089 / 4

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

76089

Product Number

4

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2004-06-09

Regulatory Status

RX

2005
31 May
Discontinued Application: 65137

Drug Name

CLARITHROMYCIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2005-05-31

65137 / 1

Active Ingredient

CLARITHROMYCIN

Application Number

65137

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2005-05-31

Regulatory Status

Discontinued

2005
31 May
Discontinued Application: 65137

Drug Name

CLARITHROMYCIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2005-05-31

65137 / 2

Active Ingredient

CLARITHROMYCIN

Application Number

65137

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2005-05-31

Regulatory Status

Discontinued

1997
26 Nov
RX Application: 74949

Drug Name

CLOZAPINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1997-11-26

74949 / 1

Active Ingredient

CLOZAPINE

Application Number

74949

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1997-11-26

Regulatory Status

RX

1997
26 Nov
RX Application: 74949

Drug Name

CLOZAPINE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1997-11-26

74949 / 2

Active Ingredient

CLOZAPINE

Application Number

74949

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1997-11-26

Regulatory Status

RX

2003
31 Jul
RX Application: 74949

Drug Name

CLOZAPINE

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2003-07-31

74949 / 3

Active Ingredient

CLOZAPINE

Application Number

74949

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2003-07-31

Regulatory Status

RX

2005
25 Apr
RX Application: 74949

Drug Name

CLOZAPINE

Product Number

4

Dosage Form

-

Strength

50MG

Approval Date

2005-04-25

74949 / 4

Active Ingredient

CLOZAPINE

Application Number

74949

Product Number

4

Dosage Form

-

Strength

50MG

Approval Date

2005-04-25

Regulatory Status

RX

2005
16 Dec
RX Application: 76809

Drug Name

CLOZAPINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2005-12-16

76809 / 1

Active Ingredient

CLOZAPINE

Application Number

76809

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2005-12-16

Regulatory Status

RX

2005
16 Dec
RX Application: 76809

Drug Name

CLOZAPINE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2005-12-16

76809 / 2

Active Ingredient

CLOZAPINE

Application Number

76809

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2005-12-16

Regulatory Status

RX

2005
16 Dec
RX Application: 76809

Drug Name

CLOZAPINE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2005-12-16

76809 / 3

Active Ingredient

CLOZAPINE

Application Number

76809

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2005-12-16

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 80630

Drug Name

CORTISONE ACETATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

80630 / 1

Active Ingredient

CORTISONE ACETATE

Application Number

80630

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83536

Drug Name

CORTISONE ACETATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

83536 / 1

Active Ingredient

CORTISONE ACETATE

Application Number

83536

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2005
25 Mar
RX Application: 65078

Drug Name

CYCLOSPORINE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2005-03-25

65078 / 1

Active Ingredient

CYCLOSPORINE

Application Number

65078

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2005-03-25

Regulatory Status

RX

2005
29 Mar
RX Application: 65110

Drug Name

CYCLOSPORINE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2005-03-29

65110 / 1

Active Ingredient

CYCLOSPORINE

Application Number

65110

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2005-03-29

Regulatory Status

RX

2005
29 Mar
RX Application: 65110

Drug Name

CYCLOSPORINE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2005-03-29

65110 / 2

Active Ingredient

CYCLOSPORINE

Application Number

65110

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2005-03-29

Regulatory Status

RX

2005
29 Mar
RX Application: 65110

Drug Name

CYCLOSPORINE

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2005-03-29

65110 / 3

Active Ingredient

CYCLOSPORINE

Application Number

65110

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2005-03-29

Regulatory Status

RX

1985
04 Sep
Discontinued Application: 70360

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1985-09-04

70360 / 1

Active Ingredient

DIAZEPAM

Application Number

70360

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1985-09-04

Regulatory Status

Discontinued

1985
04 Sep
Discontinued Application: 70361

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1985-09-04

70361 / 1

Active Ingredient

DIAZEPAM

Application Number

70361

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1985-09-04

Regulatory Status

Discontinued

1985
04 Sep
Discontinued Application: 70362

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1985-09-04

70362 / 1

Active Ingredient

DIAZEPAM

Application Number

70362

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1985-09-04

Regulatory Status

Discontinued

1986
10 Dec
RX Application: 71307

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1986-12-10

71307 / 1

Active Ingredient

DIAZEPAM

Application Number

71307

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1986-12-10

Regulatory Status

RX

1986
10 Dec
RX Application: 71321

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1986-12-10

71321 / 1

Active Ingredient

DIAZEPAM

Application Number

71321

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1986-12-10

Regulatory Status

RX

1986
10 Dec
RX Application: 71322

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1986-12-10

71322 / 1

Active Ingredient

DIAZEPAM

Application Number

71322

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1986-12-10

Regulatory Status

RX

1995
03 Mar
Discontinued Application: 74168

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1995-03-03

74168 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74168

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1995-03-03

Regulatory Status

Discontinued

1995
03 Mar
Discontinued Application: 74168

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

1995-03-03

74168 / 2

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74168

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

1995-03-03

Regulatory Status

Discontinued

1995
03 Mar
Discontinued Application: 74168

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

90MG

Approval Date

1995-03-03

74168 / 3

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74168

Product Number

3

Dosage Form

-

Strength

90MG

Approval Date

1995-03-03

Regulatory Status

Discontinued

1995
03 Mar
Discontinued Application: 74168

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

120MG

Approval Date

1995-03-03

74168 / 4

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74168

Product Number

4

Dosage Form

-

Strength

120MG

Approval Date

1995-03-03

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80762

Drug Name

DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

80762 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

80762

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80762

Drug Name

DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

80762 / 2

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

80762

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985
18 Nov
Discontinued Application: 70186

Drug Name

DISOPYRAMIDE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1985-11-18

70186 / 1

Active Ingredient

DISOPYRAMIDE PHOSPHATE

Application Number

70186

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1985-11-18

Regulatory Status

Discontinued

1985
18 Nov
Discontinued Application: 70187

Drug Name

DISOPYRAMIDE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1985-11-18

70187 / 1

Active Ingredient

DISOPYRAMIDE PHOSPHATE

Application Number

70187

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1985-11-18

Regulatory Status

Discontinued

2000
18 Oct
Discontinued Application: 75453

Drug Name

DOXAZOSIN MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2000-10-18

75453 / 1

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75453

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2000-10-18

Regulatory Status

Discontinued

2000
18 Oct
Discontinued Application: 75453

Drug Name

DOXAZOSIN MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2000-10-18

75453 / 2

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75453

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2000-10-18

Regulatory Status

Discontinued

2000
18 Oct
Discontinued Application: 75453

Drug Name

DOXAZOSIN MESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2000-10-18

75453 / 3

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75453

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2000-10-18

Regulatory Status

Discontinued

2000
18 Oct
Discontinued Application: 75453

Drug Name

DOXAZOSIN MESYLATE

Product Number

4

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2000-10-18

75453 / 4

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75453

Product Number

4

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2000-10-18

Regulatory Status

Discontinued

2000
22 Aug
Discontinued Application: 75482

Drug Name

ENALAPRIL MALEATE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2000-08-22

75482 / 1

Active Ingredient

ENALAPRIL MALEATE

Application Number

75482

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2000-08-22

Regulatory Status

Discontinued

2000
22 Aug
Discontinued Application: 75482

Drug Name

ENALAPRIL MALEATE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2000-08-22

75482 / 2

Active Ingredient

ENALAPRIL MALEATE

Application Number

75482

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2000-08-22

Regulatory Status

Discontinued

2000
22 Aug
Discontinued Application: 75482

Drug Name

ENALAPRIL MALEATE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2000-08-22

75482 / 3

Active Ingredient

ENALAPRIL MALEATE

Application Number

75482

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2000-08-22

Regulatory Status

Discontinued

2000
22 Aug
Discontinued Application: 75482

Drug Name

ENALAPRIL MALEATE

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2000-08-22

75482 / 4

Active Ingredient

ENALAPRIL MALEATE

Application Number

75482

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2000-08-22

Regulatory Status

Discontinued

2003
25 Mar
Discontinued Application: 75736

Drug Name

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

5MG;12.5MG

Approval Date

2003-03-25

75736 / 1

Active Ingredient

ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE

Application Number

75736

Product Number

1

Dosage Form

-

Strength

5MG;12.5MG

Approval Date

2003-03-25

Regulatory Status

Discontinued

2003
25 Mar
Discontinued Application: 75736

Drug Name

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

10MG;25MG

Approval Date

2003-03-25

75736 / 2

Active Ingredient

ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE

Application Number

75736

Product Number

2

Dosage Form

-

Strength

10MG;25MG

Approval Date

2003-03-25

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62237

Drug Name

ERYTHROMYCIN ESTOLATE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

62237 / 1

Active Ingredient

ERYTHROMYCIN ESTOLATE

Application Number

62237

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1997
28 Feb
Discontinued Application: 74883

Drug Name

ETODOLAC

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1997-02-28

74883 / 1

Active Ingredient

ETODOLAC

Application Number

74883

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1997-02-28

Regulatory Status

Discontinued

1998
20 Nov
Discontinued Application: 74883

Drug Name

ETODOLAC

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1998-11-20

74883 / 2

Active Ingredient

ETODOLAC

Application Number

74883

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1998-11-20

Regulatory Status

Discontinued

2001
16 Apr
RX Application: 75511

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2001-04-16

75511 / 1

Active Ingredient

FAMOTIDINE

Application Number

75511

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2001-04-16

Regulatory Status

RX

2001
16 Apr
RX Application: 75511

Drug Name

FAMOTIDINE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2001-04-16

75511 / 2

Active Ingredient

FAMOTIDINE

Application Number

75511

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2001-04-16

Regulatory Status

RX

1988
29 Aug
Discontinued Application: 72557

Drug Name

FENOPROFEN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE

Approval Date

1988-08-29

72557 / 1

Active Ingredient

FENOPROFEN CALCIUM

Application Number

72557

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE

Approval Date

1988-08-29

Regulatory Status

Discontinued

2006
19 Jun
Discontinued Application: 76340

Drug Name

FINASTERIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-06-19

76340 / 1

Active Ingredient

FINASTERIDE

Application Number

76340

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-06-19

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76077

Drug Name

FLUCONAZOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-07-29

76077 / 1

Active Ingredient

FLUCONAZOLE

Application Number

76077

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76077

Drug Name

FLUCONAZOLE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2004-07-29

76077 / 2

Active Ingredient

FLUCONAZOLE

Application Number

76077

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76077

Drug Name

FLUCONAZOLE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2004-07-29

76077 / 3

Active Ingredient

FLUCONAZOLE

Application Number

76077

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76077

Drug Name

FLUCONAZOLE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2004-07-29

76077 / 4

Active Ingredient

FLUCONAZOLE

Application Number

76077

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2007
12 Sep
Discontinued Application: 77523

Drug Name

FLUCONAZOLE

Product Number

1

Dosage Form

-

Strength

50MG/5ML

Approval Date

2007-09-12

77523 / 1

Active Ingredient

FLUCONAZOLE

Application Number

77523

Product Number

1

Dosage Form

-

Strength

50MG/5ML

Approval Date

2007-09-12

Regulatory Status

Discontinued

2007
12 Sep
Discontinued Application: 77523

Drug Name

FLUCONAZOLE

Product Number

2

Dosage Form

-

Strength

200MG/5ML

Approval Date

2007-09-12

77523 / 2

Active Ingredient

FLUCONAZOLE

Application Number

77523

Product Number

2

Dosage Form

-

Strength

200MG/5ML

Approval Date

2007-09-12

Regulatory Status

Discontinued

2002
31 Jan
RX Application: 75245

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2002-01-31

75245 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

75245

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2002-01-31

Regulatory Status

RX

2002
31 Jan
RX Application: 75245

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2002-01-31

75245 / 2

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

75245

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2002-01-31

Regulatory Status

RX

2004
28 Sep
RX Application: 75245

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2004-09-28

75245 / 3

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

75245

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2004-09-28

Regulatory Status

RX

2002
28 Feb
Discontinued Application: 75865

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2002-02-28

75865 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

75865

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2002-02-28

Regulatory Status

Discontinued

2004
30 Aug
Discontinued Application: 75865

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2004-08-30

75865 / 3

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

75865

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2004-08-30

Regulatory Status

Discontinued

1995
31 May
Discontinued Application: 74411

Drug Name

FLURBIPROFEN

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1995-05-31

74411 / 1

Active Ingredient

FLURBIPROFEN

Application Number

74411

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1995-05-31

Regulatory Status

Discontinued

1995
31 May
Discontinued Application: 74411

Drug Name

FLURBIPROFEN

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1995-05-31

74411 / 2

Active Ingredient

FLURBIPROFEN

Application Number

74411

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1995-05-31

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85539

Drug Name

FLUTEX

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1982-01-01

85539 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

85539

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85539

Drug Name

FLUTEX

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

85539 / 2

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

85539

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85539

Drug Name

FLUTEX

Product Number

3

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

85539 / 3

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

85539

Product Number

3

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1988
01 Nov
Discontinued Application: 87375

Drug Name

FLUTEX

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1988-11-01

87375 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

87375

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1988-11-01

Regulatory Status

Discontinued

1988
01 Nov
Discontinued Application: 87376

Drug Name

FLUTEX

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1988-11-01

87376 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

87376

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1988-11-01

Regulatory Status

Discontinued

1988
01 Nov
Discontinued Application: 87377

Drug Name

FLUTEX

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1988-11-01

87377 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

87377

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1988-11-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83000

Drug Name

FOLIC ACID

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

83000 / 1

Active Ingredient

FOLIC ACID

Application Number

83000

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2004
28 Apr
RX Application: 76017

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2004-04-28

76017 / 1

Active Ingredient

GABAPENTIN

Application Number

76017

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2004-04-28

Regulatory Status

RX

2004
28 Apr
RX Application: 76017

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2004-04-28

76017 / 2

Active Ingredient

GABAPENTIN

Application Number

76017

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2004-04-28

Regulatory Status

RX

2004
28 Apr
RX Application: 76017

Drug Name

GABAPENTIN

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2004-04-28

76017 / 3

Active Ingredient

GABAPENTIN

Application Number

76017

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2004-04-28

Regulatory Status

RX

2005
29 Apr
Discontinued Application: 76017

Drug Name

GABAPENTIN

Product Number

4

Dosage Form

-

Strength

600MG

Approval Date

2005-04-29

76017 / 4

Active Ingredient

GABAPENTIN

Application Number

76017

Product Number

4

Dosage Form

-

Strength

600MG

Approval Date

2005-04-29

Regulatory Status

Discontinued

2005
29 Apr
Discontinued Application: 76017

Drug Name

GABAPENTIN

Product Number

5

Dosage Form

-

Strength

800MG

Approval Date

2005-04-29

76017 / 5

Active Ingredient

GABAPENTIN

Application Number

76017

Product Number

5

Dosage Form

-

Strength

800MG

Approval Date

2005-04-29

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84437

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

84437 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

84437

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84443

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

84443 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

84443

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84469

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

84469 / 2

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

84469

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84581

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

84581 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

84581

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
10 Apr
Discontinued Application: 88358

Drug Name

HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50

Product Number

1

Dosage Form

-

Strength

100MG;50MG

Approval Date

1984-04-10

88358 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

88358

Product Number

1

Dosage Form

-

Strength

100MG;50MG

Approval Date

1984-04-10

Regulatory Status

Discontinued

1984
10 Apr
Discontinued Application: 88356

Drug Name

HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 25/25

Product Number

1

Dosage Form

-

Strength

25MG;25MG

Approval Date

1984-04-10

88356 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

88356

Product Number

1

Dosage Form

-

Strength

25MG;25MG

Approval Date

1984-04-10

Regulatory Status

Discontinued

1984
10 Apr
Discontinued Application: 88357

Drug Name

HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50

Product Number

1

Dosage Form

-

Strength

50MG;50MG

Approval Date

1984-04-10

88357 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

88357

Product Number

1

Dosage Form

-

Strength

50MG;50MG

Approval Date

1984-04-10

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84291

Drug Name

HYDRALAZINE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE AND RESERPINE

Product Number

1

Dosage Form

-

Strength

25MG;15MG;0.1MG

Approval Date

1982-01-01

84291 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE

Application Number

84291

Product Number

1

Dosage Form

-

Strength

25MG;15MG;0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2005
13 Jul
Discontinued Application: 77005

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2005-07-13

77005 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

77005

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2005-07-13

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 83177

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

83177 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

83177

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 83177

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

83177 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

83177

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

RX

2024
19 Sep
RX Application: 83177

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2024-09-19

83177 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

83177

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2024-09-19

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 84658

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

84658 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

84658

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85022

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

85022 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

85022

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83568

Drug Name

HYDROCHLOROTHIAZIDE W/ RESERPINE

Product Number

1

Dosage Form

-

Strength

50MG;0.1MG

Approval Date

1982-01-01

83568 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; RESERPINE

Application Number

83568

Product Number

1

Dosage Form

-

Strength

50MG;0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83571

Drug Name

HYDROCHLOROTHIAZIDE W/ RESERPINE

Product Number

1

Dosage Form

-

Strength

25MG;0.125MG

Approval Date

1982-01-01

83571 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; RESERPINE

Application Number

83571

Product Number

1

Dosage Form

-

Strength

25MG;0.125MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83572

Drug Name

HYDROCHLOROTHIAZIDE W/ RESERPINE

Product Number

1

Dosage Form

-

Strength

25MG;0.1MG

Approval Date

1982-01-01

83572 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; RESERPINE

Application Number

83572

Product Number

1

Dosage Form

-

Strength

25MG;0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83573

Drug Name

HYDROCHLOROTHIAZIDE W/ RESERPINE

Product Number

1

Dosage Form

-

Strength

50MG;0.125MG

Approval Date

1982-01-01

83573 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; RESERPINE

Application Number

83573

Product Number

1

Dosage Form

-

Strength

50MG;0.125MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1988
21 Apr
Discontinued Application: 89696

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1988-04-21

89696 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

89696

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1988-04-21

Regulatory Status

Discontinued

1999
19 Jul
Discontinued Application: 40285

Drug Name

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

Product Number

1

Dosage Form

-

Strength

1.5MG/5ML;5MG/5ML

Approval Date

1999-07-19

40285 / 1

Active Ingredient

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

Application Number

40285

Product Number

1

Dosage Form

-

Strength

1.5MG/5ML;5MG/5ML

Approval Date

1999-07-19

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85733

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

85733 / 1

Active Ingredient

HYDROCORTISONE

Application Number

85733

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87185

Drug Name

HYDROGENATED ERGOT ALKALOIDS

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

87185 / 1

Active Ingredient

ERGOLOID MESYLATES

Application Number

87185

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87186

Drug Name

HYDROGENATED ERGOT ALKALOIDS

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1982-01-01

87186 / 1

Active Ingredient

ERGOLOID MESYLATES

Application Number

87186

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83877

Drug Name

HYDROSERPINE PLUS (R-H-H)

Product Number

1

Dosage Form

-

Strength

25MG;15MG;0.1MG

Approval Date

1982-01-01

83877 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE

Application Number

83877

Product Number

1

Dosage Form

-

Strength

25MG;15MG;0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87216

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

87216 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

87216

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87410

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

87410 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

87410

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87411

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

87411 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

87411

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
05 Mar
Discontinued Application: 87760

Drug Name

HYDROXYZINE PAMOATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG HYDROCHLORIDE

Approval Date

1982-03-05

87760 / 1

Active Ingredient

HYDROXYZINE PAMOATE

Application Number

87760

Product Number

1

Dosage Form

-

Strength

EQ 50MG HYDROCHLORIDE

Approval Date

1982-03-05

Regulatory Status

Discontinued

1982
05 Mar
Discontinued Application: 87761

Drug Name

HYDROXYZINE PAMOATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG HYDROCHLORIDE

Approval Date

1982-03-05

87761 / 1

Active Ingredient

HYDROXYZINE PAMOATE

Application Number

87761

Product Number

1

Dosage Form

-

Strength

EQ 25MG HYDROCHLORIDE

Approval Date

1982-03-05

Regulatory Status

Discontinued

1986
23 Sep
Discontinued Application: 71145

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1986-09-23

71145 / 1

Active Ingredient

IBUPROFEN

Application Number

71145

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1986-09-23

Regulatory Status

Discontinued

1986
23 Sep
Discontinued Application: 71146

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1986-09-23

71146 / 1

Active Ingredient

IBUPROFEN

Application Number

71146

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1986-09-23

Regulatory Status

Discontinued

1987
27 Oct
Discontinued Application: 71154

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1987-10-27

71154 / 1

Active Ingredient

IBUPROFEN

Application Number

71154

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1987-10-27

Regulatory Status

Discontinued

1987
08 May
Discontinued Application: 71769

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

1987-05-08

71769 / 1

Active Ingredient

IBUPROFEN

Application Number

71769

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

1987-05-08

Regulatory Status

Discontinued

1988
29 Apr
Discontinued Application: 72040

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1988-04-29

72040 / 1

Active Ingredient

IBUPROFEN

Application Number

72040

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1988-04-29

Regulatory Status

Discontinued

1984
04 May
Discontinued Application: 18730

Drug Name

INDOMETHACIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1984-05-04

18730 / 1

Active Ingredient

INDOMETHACIN

Application Number

18730

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1984-05-04

Regulatory Status

Discontinued

1984
04 May
Discontinued Application: 18730

Drug Name

INDOMETHACIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1984-05-04

18730 / 2

Active Ingredient

INDOMETHACIN

Application Number

18730

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1984-05-04

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80270

Drug Name

ISONIAZID

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

80270 / 1

Active Ingredient

ISONIAZID

Application Number

80270

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83610

Drug Name

ISONIAZID

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

83610 / 1

Active Ingredient

ISONIAZID

Application Number

83610

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2000
19 Jun
Discontinued Application: 75448

Drug Name

ISOSORBIDE MONONITRATE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2000-06-19

75448 / 1

Active Ingredient

ISOSORBIDE MONONITRATE

Application Number

75448

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2000-06-19

Regulatory Status

Discontinued

2001
07 Aug
Discontinued Application: 75448

Drug Name

ISOSORBIDE MONONITRATE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2001-08-07

75448 / 2

Active Ingredient

ISOSORBIDE MONONITRATE

Application Number

75448

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2001-08-07

Regulatory Status

Discontinued

2001
07 Aug
Discontinued Application: 75448

Drug Name

ISOSORBIDE MONONITRATE

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

2001-08-07

75448 / 3

Active Ingredient

ISOSORBIDE MONONITRATE

Application Number

75448

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

2001-08-07

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83784

Drug Name

MECLIZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1982-01-01

83784 / 1

Active Ingredient

MECLIZINE HYDROCHLORIDE

Application Number

83784

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84976

Drug Name

MECLIZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

84976 / 1

Active Ingredient

MECLIZINE HYDROCHLORIDE

Application Number

84976

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 15438

Drug Name

MEPROBAMATE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

15438 / 1

Active Ingredient

MEPROBAMATE

Application Number

15438

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 15438

Drug Name

MEPROBAMATE

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

1982-01-01

15438 / 2

Active Ingredient

MEPROBAMATE

Application Number

15438

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84181

Drug Name

MEPROBAMATE

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1982-01-01

84181 / 1

Active Ingredient

MEPROBAMATE

Application Number

84181

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2002
24 Jan
Discontinued Application: 75975

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2002-01-24

75975 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

75975

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2002-01-24

Regulatory Status

Discontinued

2002
24 Jan
Discontinued Application: 75975

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2002-01-24

75975 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

75975

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2002-01-24

Regulatory Status

Discontinued

2002
24 Jan
Discontinued Application: 75975

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2002-01-24

75975 / 3

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

75975

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2002-01-24

Regulatory Status

Discontinued

2002
24 Jan
Discontinued Application: 75975

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

625MG

Approval Date

2002-01-24

75975 / 4

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

75975

Product Number

4

Dosage Form

-

Strength

625MG

Approval Date

2002-01-24

Regulatory Status

Discontinued

2002
24 Jan
Discontinued Application: 75975

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

750MG

Approval Date

2002-01-24

75975 / 5

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

75975

Product Number

5

Dosage Form

-

Strength

750MG

Approval Date

2002-01-24

Regulatory Status

Discontinued

2003
01 Dec
Discontinued Application: 76545

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2003-12-01

76545 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

76545

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2003-12-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84648

Drug Name

METHOCARBAMOL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

84648 / 1

Active Ingredient

METHOCARBAMOL

Application Number

84648

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84649

Drug Name

METHOCARBAMOL

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

1982-01-01

84649 / 1

Active Ingredient

METHOCARBAMOL

Application Number

84649

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
22 Dec
Discontinued Application: 87211

Drug Name

METHOCARBAMOL AND ASPIRIN

Product Number

1

Dosage Form

-

Strength

325MG;400MG

Approval Date

1982-12-22

87211 / 1

Active Ingredient

ASPIRIN; METHOCARBAMOL

Application Number

87211

Product Number

1

Dosage Form

-

Strength

325MG;400MG

Approval Date

1982-12-22

Regulatory Status

Discontinued

1982
18 May
Discontinued Application: 87786

Drug Name

METHYCLOTHIAZIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-05-18

87786 / 1

Active Ingredient

METHYCLOTHIAZIDE

Application Number

87786

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-05-18

Regulatory Status

Discontinued

1982
03 Jun
Discontinued Application: 87913

Drug Name

METHYCLOTHIAZIDE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1982-06-03

87913 / 1

Active Ingredient

METHYCLOTHIAZIDE

Application Number

87913

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1982-06-03

Regulatory Status

Discontinued

1988
08 Mar
Discontinued Application: 71458

Drug Name

METHYLDOPA AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

15MG;250MG

Approval Date

1988-03-08

71458 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; METHYLDOPA

Application Number

71458

Product Number

1

Dosage Form

-

Strength

15MG;250MG

Approval Date

1988-03-08

Regulatory Status

Discontinued

1988
08 Mar
Discontinued Application: 71459

Drug Name

METHYLDOPA AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG;250MG

Approval Date

1988-03-08

71459 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; METHYLDOPA

Application Number

71459

Product Number

1

Dosage Form

-

Strength

25MG;250MG

Approval Date

1988-03-08

Regulatory Status

Discontinued

1988
08 Mar
Discontinued Application: 71460

Drug Name

METHYLDOPA AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

30MG;500MG

Approval Date

1988-03-08

71460 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; METHYLDOPA

Application Number

71460

Product Number

1

Dosage Form

-

Strength

30MG;500MG

Approval Date

1988-03-08

Regulatory Status

Discontinued

1988
08 Mar
Discontinued Application: 71461

Drug Name

METHYLDOPA AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

50MG;500MG

Approval Date

1988-03-08

71461 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; METHYLDOPA

Application Number

71461

Product Number

1

Dosage Form

-

Strength

50MG;500MG

Approval Date

1988-03-08

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18517

Drug Name

METRONIDAZOLE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

18517 / 1

Active Ingredient

METRONIDAZOLE

Application Number

18517

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
05 May
Discontinued Application: 18517

Drug Name

METRONIDAZOLE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-05-05

18517 / 2

Active Ingredient

METRONIDAZOLE

Application Number

18517

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-05-05

Regulatory Status

Discontinued

2003
22 Dec
Discontinued Application: 76244

Drug Name

MIRTAZAPINE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2003-12-22

76244 / 1

Active Ingredient

MIRTAZAPINE

Application Number

76244

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2003-12-22

Regulatory Status

Discontinued

2003
22 Dec
Discontinued Application: 76244

Drug Name

MIRTAZAPINE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2003-12-22

76244 / 2

Active Ingredient

MIRTAZAPINE

Application Number

76244

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2003-12-22

Regulatory Status

Discontinued

2003
22 Dec
Discontinued Application: 76244

Drug Name

MIRTAZAPINE

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2003-12-22

76244 / 3

Active Ingredient

MIRTAZAPINE

Application Number

76244

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2003-12-22

Regulatory Status

Discontinued

1995
28 Feb
Discontinued Application: 74111

Drug Name

NAPROXEN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1995-02-28

74111 / 1

Active Ingredient

NAPROXEN

Application Number

74111

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1995-02-28

Regulatory Status

Discontinued

1995
28 Feb
Discontinued Application: 74111

Drug Name

NAPROXEN

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

1995-02-28

74111 / 2

Active Ingredient

NAPROXEN

Application Number

74111

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

1995-02-28

Regulatory Status

Discontinued

1995
28 Feb
Discontinued Application: 74111

Drug Name

NAPROXEN

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1995-02-28

74111 / 3

Active Ingredient

NAPROXEN

Application Number

74111

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1995-02-28

Regulatory Status

Discontinued

1995
14 Mar
Discontinued Application: 74230

Drug Name

NAPROXEN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1995-03-14

74230 / 1

Active Ingredient

NAPROXEN SODIUM

Application Number

74230

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1995-03-14

Regulatory Status

Discontinued

1995
14 Mar
Discontinued Application: 74230

Drug Name

NAPROXEN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1995-03-14

74230 / 2

Active Ingredient

NAPROXEN SODIUM

Application Number

74230

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1995-03-14

Regulatory Status

Discontinued

2003
16 Sep
Discontinued Application: 75763

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-09-16

75763 / 1

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

75763

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-09-16

Regulatory Status

Discontinued

2003
16 Sep
Discontinued Application: 75763

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2003-09-16

75763 / 2

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

75763

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2003-09-16

Regulatory Status

Discontinued

2003
16 Sep
Discontinued Application: 75763

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2003-09-16

75763 / 3

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

75763

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2003-09-16

Regulatory Status

Discontinued

2003
16 Sep
Discontinued Application: 75763

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2003-09-16

75763 / 4

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

75763

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2003-09-16

Regulatory Status

Discontinued

2003
16 Sep
Discontinued Application: 75763

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

250MG

Approval Date

2003-09-16

75763 / 5

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

75763

Product Number

5

Dosage Form

-

Strength

250MG

Approval Date

2003-09-16

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83180

Drug Name

NIACIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

83180 / 1

Active Ingredient

NIACIN

Application Number

83180

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2009
18 Feb
Discontinued Application: 76880

Drug Name

NICOTINE POLACRILEX

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2009-02-18

76880 / 1

Active Ingredient

NICOTINE POLACRILEX

Application Number

76880

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2009-02-18

Regulatory Status

Discontinued

2009
18 Feb
Discontinued Application: 77850

Drug Name

NICOTINE POLACRILEX

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2009-02-18

77850 / 1

Active Ingredient

NICOTINE POLACRILEX

Application Number

77850

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2009-02-18

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80078

Drug Name

NITROFURANTOIN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

80078 / 1

Active Ingredient

NITROFURANTOIN

Application Number

80078

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80078

Drug Name

NITROFURANTOIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

80078 / 2

Active Ingredient

NITROFURANTOIN

Application Number

80078

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1988
04 Apr
Discontinued Application: 87427

Drug Name

NOGENIC HC

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1988-04-04

87427 / 1

Active Ingredient

HYDROCORTISONE

Application Number

87427

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1988-04-04

Regulatory Status

Discontinued

2015
29 Apr
Discontinued Application: 77301

Drug Name

OLANZAPINE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2015-04-29

77301 / 1

Active Ingredient

OLANZAPINE

Application Number

77301

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2015-04-29

Regulatory Status

Discontinued

2002
13 May
Discontinued Application: 75846

Drug Name

OXAPROZIN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2002-05-13

75846 / 1

Active Ingredient

OXAPROZIN

Application Number

75846

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2002-05-13

Regulatory Status

Discontinued

1987
03 Aug
Discontinued Application: 70943

Drug Name

OXAZEPAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1987-08-03

70943 / 1

Active Ingredient

OXAZEPAM

Application Number

70943

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1987-08-03

Regulatory Status

Discontinued

1987
03 Aug
Discontinued Application: 70944

Drug Name

OXAZEPAM

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1987-08-03

70944 / 1

Active Ingredient

OXAZEPAM

Application Number

70944

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1987-08-03

Regulatory Status

Discontinued

1987
03 Aug
Discontinued Application: 70945

Drug Name

OXAZEPAM

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1987-08-03

70945 / 1

Active Ingredient

OXAZEPAM

Application Number

70945

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1987-08-03

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60073

Drug Name

PENICILLIN G POTASSIUM

Product Number

4

Dosage Form

-

Strength

400,000 UNITS

Approval Date

1982-01-01

60073 / 4

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

60073

Product Number

4

Dosage Form

-

Strength

400,000 UNITS

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60518

Drug Name

PENICILLIN V POTASSIUM

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE

Approval Date

1982-01-01

60518 / 1

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

60518

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60518

Drug Name

PENICILLIN V POTASSIUM

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

60518 / 2

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

60518

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60518

Drug Name

PENICILLIN V POTASSIUM

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

60518 / 3

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

60518

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

2003
04 Sep
Discontinued Application: 76094

Drug Name

PERGOLIDE MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE

Approval Date

2003-09-04

76094 / 1

Active Ingredient

PERGOLIDE MESYLATE

Application Number

76094

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE

Approval Date

2003-09-04

Regulatory Status

Discontinued

2003
04 Sep
Discontinued Application: 76094

Drug Name

PERGOLIDE MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

2003-09-04

76094 / 2

Active Ingredient

PERGOLIDE MESYLATE

Application Number

76094

Product Number

2

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

2003-09-04

Regulatory Status

Discontinued

2003
04 Sep
Discontinued Application: 76094

Drug Name

PERGOLIDE MESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2003-09-04

76094 / 3

Active Ingredient

PERGOLIDE MESYLATE

Application Number

76094

Product Number

3

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2003-09-04

Regulatory Status

Discontinued

1986
11 Sep
Discontinued Application: 70935

Drug Name

PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG;2MG

Approval Date

1986-09-11

70935 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

Application Number

70935

Product Number

1

Dosage Form

-

Strength

10MG;2MG

Approval Date

1986-09-11

Regulatory Status

Discontinued

1986
11 Sep
Discontinued Application: 70936

Drug Name

PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG;2MG

Approval Date

1986-09-11

70936 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

Application Number

70936

Product Number

1

Dosage Form

-

Strength

25MG;2MG

Approval Date

1986-09-11

Regulatory Status

Discontinued

1986
11 Sep
Discontinued Application: 70937

Drug Name

PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG;4MG

Approval Date

1986-09-11

70937 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

Application Number

70937

Product Number

1

Dosage Form

-

Strength

10MG;4MG

Approval Date

1986-09-11

Regulatory Status

Discontinued

1986
11 Sep
Discontinued Application: 70938

Drug Name

PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG;4MG

Approval Date

1986-09-11

70938 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

Application Number

70938

Product Number

1

Dosage Form

-

Strength

25MG;4MG

Approval Date

1986-09-11

Regulatory Status

Discontinued

1986
12 Sep
Discontinued Application: 70939

Drug Name

PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG;4MG

Approval Date

1986-09-12

70939 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

Application Number

70939

Product Number

1

Dosage Form

-

Strength

50MG;4MG

Approval Date

1986-09-12

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83682

Drug Name

PHENDIMETRAZINE TARTRATE

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

83682 / 1

Active Ingredient

PHENDIMETRAZINE TARTRATE

Application Number

83682

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85611

Drug Name

PHENDIMETRAZINE TARTRATE

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

85611 / 1

Active Ingredient

PHENDIMETRAZINE TARTRATE

Application Number

85611

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85612

Drug Name

PHENDIMETRAZINE TARTRATE

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

85612 / 1

Active Ingredient

PHENDIMETRAZINE TARTRATE

Application Number

85612

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85553

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

1982-01-01

85553 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

85553

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86329

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

86329 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

86329

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1983
24 Jun
Discontinued Application: 88218

Drug Name

PHENYLBUTAZONE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1983-06-24

88218 / 1

Active Ingredient

PHENYLBUTAZONE

Application Number

88218

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1983-06-24

Regulatory Status

Discontinued

1996
03 Jun
Discontinued Application: 74148

Drug Name

PIROXICAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1996-06-03

74148 / 1

Active Ingredient

PIROXICAM

Application Number

74148

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1996-06-03

Regulatory Status

Discontinued

1996
03 Jun
Discontinued Application: 74148

Drug Name

PIROXICAM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1996-06-03

74148 / 2

Active Ingredient

PIROXICAM

Application Number

74148

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1996-06-03

Regulatory Status

Discontinued

-
Unclassified Application: 71994

Drug Name

PRAZOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

-

71994 / 1

Active Ingredient

PRAZOSIN HYDROCHLORIDE

Application Number

71994

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

-

Regulatory Status

Unclassified

1999
28 May
Discontinued Application: 40287

Drug Name

PREDNISOLONE

Product Number

1

Dosage Form

-

Strength

15MG/5ML

Approval Date

1999-05-28

40287 / 1

Active Ingredient

PREDNISOLONE

Application Number

40287

Product Number

1

Dosage Form

-

Strength

15MG/5ML

Approval Date

1999-05-28

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80378

Drug Name

PREDNISOLONE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

80378 / 1

Active Ingredient

PREDNISOLONE

Application Number

80378

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80283

Drug Name

PREDNISONE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

80283 / 1

Active Ingredient

PREDNISONE

Application Number

80283

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84133

Drug Name

PREDNISONE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

84133 / 1

Active Ingredient

PREDNISONE

Application Number

84133

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84134

Drug Name

PREDNISONE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

84134 / 1

Active Ingredient

PREDNISONE

Application Number

84134

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
09 May
Discontinued Application: 83740

Drug Name

PROBENECID

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1984-05-09

83740 / 1

Active Ingredient

PROBENECID

Application Number

83740

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1984-05-09

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84595

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

1982-01-01

84595 / 1

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

84595

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84604

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

84604 / 1

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

84604

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84606

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

84606 / 1

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

84606

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1998
20 Jan
Discontinued Application: 40162

Drug Name

PROCHLORPERAZINE MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1998-01-20

40162 / 1

Active Ingredient

PROCHLORPERAZINE MALEATE

Application Number

40162

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1998-01-20

Regulatory Status

Discontinued

1998
20 Jan
Discontinued Application: 40162

Drug Name

PROCHLORPERAZINE MALEATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1998-01-20

40162 / 2

Active Ingredient

PROCHLORPERAZINE MALEATE

Application Number

40162

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1998-01-20

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83603

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

83603 / 1

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

83603

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83604

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1982-01-01

83604 / 1

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

83604

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83613

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

83613 / 1

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

83613

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
07 Dec
Discontinued Application: 83077

Drug Name

PROPOXYPHENE COMPOUND 65

Product Number

2

Dosage Form

-

Strength

389MG;32.4MG;65MG

Approval Date

1984-12-07

83077 / 2

Active Ingredient

ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE

Application Number

83077

Product Number

2

Dosage Form

-

Strength

389MG;32.4MG;65MG

Approval Date

1984-12-07

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83597

Drug Name

PROPOXYPHENE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

32MG

Approval Date

1982-01-01

83597 / 1

Active Ingredient

PROPOXYPHENE HYDROCHLORIDE

Application Number

83597

Product Number

1

Dosage Form

-

Strength

32MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985
02 Aug
Discontinued Application: 70146

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

1985-08-02

70146 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Application Number

70146

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

1985-08-02

Regulatory Status

Discontinued

1988
29 Jul
Discontinued Application: 72063

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1988-07-29

72063 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

72063

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1988-07-29

Regulatory Status

Discontinued

1988
29 Jul
Discontinued Application: 72066

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1988-07-29

72066 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

72066

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1988-07-29

Regulatory Status

Discontinued

1988
29 Jul
Discontinued Application: 72067

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1988-07-29

72067 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

72067

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1988-07-29

Regulatory Status

Discontinued

1988
29 Jul
Discontinued Application: 72068

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

1988-07-29

72068 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

72068

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

1988-07-29

Regulatory Status

Discontinued

1988
29 Jul
Discontinued Application: 72069

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1988-07-29

72069 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

72069

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1988-07-29

Regulatory Status

Discontinued

1988
01 Dec
Discontinued Application: 71552

Drug Name

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG;40MG

Approval Date

1988-12-01

71552 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE

Application Number

71552

Product Number

1

Dosage Form

-

Strength

25MG;40MG

Approval Date

1988-12-01

Regulatory Status

Discontinued

1988
01 Dec
Discontinued Application: 71553

Drug Name

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG;80MG

Approval Date

1988-12-01

71553 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE

Application Number

71553

Product Number

1

Dosage Form

-

Strength

25MG;80MG

Approval Date

1988-12-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84549

Drug Name

QUINIDINE SULFATE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

84549 / 1

Active Ingredient

QUINIDINE SULFATE

Application Number

84549

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11521

Drug Name

RAUWOLFIA SERPENTINA

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

11521 / 1

Active Ingredient

RAUWOLFIA SERPENTINA ROOT

Application Number

11521

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11521

Drug Name

RAUWOLFIA SERPENTINA

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

11521 / 2

Active Ingredient

RAUWOLFIA SERPENTINA ROOT

Application Number

11521

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11185

Drug Name

RESERPINE

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

11185 / 1

Active Ingredient

RESERPINE

Application Number

11185

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11185

Drug Name

RESERPINE

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

11185 / 2

Active Ingredient

RESERPINE

Application Number

11185

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985
11 Jan
Discontinued Application: 88932

Drug Name

RESERPINE AND HYDROFLUMETHIAZIDE

Product Number

1

Dosage Form

-

Strength

50MG;0.125MG

Approval Date

1985-01-11

88932 / 1

Active Ingredient

HYDROFLUMETHIAZIDE; RESERPINE

Application Number

88932

Product Number

1

Dosage Form

-

Strength

50MG;0.125MG

Approval Date

1985-01-11

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85869

Drug Name

SECOBARBITAL SODIUM

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

85869 / 1

Active Ingredient

SECOBARBITAL SODIUM

Application Number

85869

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85777

Drug Name

SELENIUM SULFIDE

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

1982-01-01

85777 / 1

Active Ingredient

SELENIUM SULFIDE

Application Number

85777

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

1982-01-01

Regulatory Status

Discontinued

2006
30 Jun
Discontinued Application: 75719

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2006-06-30

75719 / 1

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

75719

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2006-06-30

Regulatory Status

Discontinued

2006
30 Jun
Discontinued Application: 75719

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2006-06-30

75719 / 2

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

75719

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2006-06-30

Regulatory Status

Discontinued

2006
30 Jun
Discontinued Application: 75719

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2006-06-30

75719 / 3

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

75719

Product Number

3

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2006-06-30

Regulatory Status

Discontinued

2006
23 Jun
Discontinued Application: 76052

Drug Name

SIMVASTATIN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-06-23

76052 / 1

Active Ingredient

SIMVASTATIN

Application Number

76052

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-06-23

Regulatory Status

Discontinued

2006
23 Jun
Discontinued Application: 76052

Drug Name

SIMVASTATIN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2006-06-23

76052 / 2

Active Ingredient

SIMVASTATIN

Application Number

76052

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2006-06-23

Regulatory Status

Discontinued

2006
23 Jun
Discontinued Application: 76052

Drug Name

SIMVASTATIN

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2006-06-23

76052 / 3

Active Ingredient

SIMVASTATIN

Application Number

76052

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2006-06-23

Regulatory Status

Discontinued

2006
23 Jun
Discontinued Application: 76052

Drug Name

SIMVASTATIN

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2006-06-23

76052 / 4

Active Ingredient

SIMVASTATIN

Application Number

76052

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2006-06-23

Regulatory Status

Discontinued

2006
20 Dec
Discontinued Application: 76052

Drug Name

SIMVASTATIN

Product Number

5

Dosage Form

-

Strength

80MG

Approval Date

2006-12-20

76052 / 5

Active Ingredient

SIMVASTATIN

Application Number

76052

Product Number

5

Dosage Form

-

Strength

80MG

Approval Date

2006-12-20

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83484

Drug Name

SODIUM BUTABARBITAL

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

83484 / 1

Active Ingredient

BUTABARBITAL SODIUM

Application Number

83484

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84040

Drug Name

SODIUM BUTABARBITAL

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

84040 / 1

Active Ingredient

BUTABARBITAL SODIUM

Application Number

84040

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83461

Drug Name

SODIUM PENTOBARBITAL

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

83461 / 1

Active Ingredient

PENTOBARBITAL SODIUM

Application Number

83461

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83461

Drug Name

SODIUM PENTOBARBITAL

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

83461 / 2

Active Ingredient

PENTOBARBITAL SODIUM

Application Number

83461

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87108

Drug Name

SPIRONOLACTONE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

87108 / 1

Active Ingredient

SPIRONOLACTONE

Application Number

87108

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
24 May
Discontinued Application: 87004

Drug Name

SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

25MG;25MG

Approval Date

1982-05-24

87004 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

Application Number

87004

Product Number

2

Dosage Form

-

Strength

25MG;25MG

Approval Date

1982-05-24

Regulatory Status

Discontinued

1982
01 Jun
Discontinued Application: 87769

Drug Name

SULFINPYRAZONE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-06-01

87769 / 1

Active Ingredient

SULFINPYRAZONE

Application Number

87769

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-06-01

Regulatory Status

Discontinued

1982
19 Nov
Discontinued Application: 87770

Drug Name

SULFINPYRAZONE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-11-19

87770 / 1

Active Ingredient

SULFINPYRAZONE

Application Number

87770

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-11-19

Regulatory Status

Discontinued

2003
20 Feb
Discontinued Application: 75740

Drug Name

TAMOXIFEN CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2003-02-20

75740 / 1

Active Ingredient

TAMOXIFEN CITRATE

Application Number

75740

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2003-02-20

Regulatory Status

Discontinued

2003
20 Feb
Discontinued Application: 75740

Drug Name

TAMOXIFEN CITRATE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2003-02-20

75740 / 2

Active Ingredient

TAMOXIFEN CITRATE

Application Number

75740

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2003-02-20

Regulatory Status

Discontinued

2000
21 Apr
Discontinued Application: 74530

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2000-04-21

74530 / 1

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

74530

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2000-04-21

Regulatory Status

Discontinued

2000
21 Apr
Discontinued Application: 74530

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2000-04-21

74530 / 2

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

74530

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2000-04-21

Regulatory Status

Discontinued

2000
21 Apr
Discontinued Application: 74530

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2000-04-21

74530 / 3

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

74530

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2000-04-21

Regulatory Status

Discontinued

2000
21 Apr
Discontinued Application: 74530

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2000-04-21

74530 / 4

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

74530

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2000-04-21

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60704

Drug Name

TETRACYCLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

60704 / 1

Active Ingredient

TETRACYCLINE HYDROCHLORIDE

Application Number

60704

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60704

Drug Name

TETRACYCLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

60704 / 2

Active Ingredient

TETRACYCLINE HYDROCHLORIDE

Application Number

60704

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61468

Drug Name

TETRAMED

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

1982-01-01

61468 / 1

Active Ingredient

TETRACYCLINE HYDROCHLORIDE

Application Number

61468

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2015
23 Feb
RX Application: 77006

Drug Name

TOLTERODINE TARTRATE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2015-02-23

77006 / 1

Active Ingredient

TOLTERODINE TARTRATE

Application Number

77006

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2015-02-23

Regulatory Status

RX

2015
23 Feb
RX Application: 77006

Drug Name

TOLTERODINE TARTRATE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2015-02-23

77006 / 2

Active Ingredient

TOLTERODINE TARTRATE

Application Number

77006

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2015-02-23

Regulatory Status

RX

2002
03 Jul
Discontinued Application: 75963

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-07-03

75963 / 1

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

75963

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-07-03

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83750

Drug Name

TRIAMCINOLONE

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

83750 / 1

Active Ingredient

TRIAMCINOLONE

Application Number

83750

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1988
01 Nov
Discontinued Application: 87428

Drug Name

TRIATEX

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1988-11-01

87428 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

87428

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1988-11-01

Regulatory Status

Discontinued

1988
01 Nov
Discontinued Application: 87429

Drug Name

TRIATEX

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1988-11-01

87429 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

87429

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1988-11-01

Regulatory Status

Discontinued

1988
01 Nov
Discontinued Application: 87430

Drug Name

TRIATEX

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1988-11-01

87430 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

87430

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1988-11-01

Regulatory Status

Discontinued

1982
19 Nov
Discontinued Application: 87328

Drug Name

TRIFLUOPERAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1982-11-19

87328 / 1

Active Ingredient

TRIFLUOPERAZINE HYDROCHLORIDE

Application Number

87328

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1982-11-19

Regulatory Status

Discontinued

1982
19 Nov
Discontinued Application: 87612

Drug Name

TRIFLUOPERAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

1982-11-19

87612 / 1

Active Ingredient

TRIFLUOPERAZINE HYDROCHLORIDE

Application Number

87612

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

1982-11-19

Regulatory Status

Discontinued

1982
19 Nov
Discontinued Application: 87613

Drug Name

TRIFLUOPERAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1982-11-19

87613 / 1

Active Ingredient

TRIFLUOPERAZINE HYDROCHLORIDE

Application Number

87613

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1982-11-19

Regulatory Status

Discontinued

1982
19 Nov
Discontinued Application: 87614

Drug Name

TRIFLUOPERAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1982-11-19

87614 / 1

Active Ingredient

TRIFLUOPERAZINE HYDROCHLORIDE

Application Number

87614

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1982-11-19

Regulatory Status

Discontinued

1984
12 Dec
Discontinued Application: 85273

Drug Name

TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG;2.5MG

Approval Date

1984-12-12

85273 / 1

Active Ingredient

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

Application Number

85273

Product Number

1

Dosage Form

-

Strength

60MG;2.5MG

Approval Date

1984-12-12

Regulatory Status

Discontinued

2016
04 Jan
Discontinued Application: 77530

Drug Name

VALSARTAN

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2016-01-04

77530 / 1

Active Ingredient

VALSARTAN

Application Number

77530

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2016-01-04

Regulatory Status

Discontinued

2016
04 Jan
Discontinued Application: 77530

Drug Name

VALSARTAN

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2016-01-04

77530 / 2

Active Ingredient

VALSARTAN

Application Number

77530

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2016-01-04

Regulatory Status

Discontinued

2016
04 Jan
Discontinued Application: 77530

Drug Name

VALSARTAN

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2016-01-04

77530 / 3

Active Ingredient

VALSARTAN

Application Number

77530

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2016-01-04

Regulatory Status

Discontinued

2016
04 Jan
Discontinued Application: 77530

Drug Name

VALSARTAN

Product Number

4

Dosage Form

-

Strength

320MG

Approval Date

2016-01-04

77530 / 4

Active Ingredient

VALSARTAN

Application Number

77530

Product Number

4

Dosage Form

-

Strength

320MG

Approval Date

2016-01-04

Regulatory Status

Discontinued

1992
31 Jul
Discontinued Application: 73568

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

240MG

Approval Date

1992-07-31

73568 / 1

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

73568

Product Number

1

Dosage Form

-

Strength

240MG

Approval Date

1992-07-31

Regulatory Status

Discontinued

1997
10 Oct
Discontinued Application: 73568

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

1997-10-10

73568 / 2

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

73568

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

1997-10-10

Regulatory Status

Discontinued

1994
31 Jan
Discontinued Application: 74330

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

180MG

Approval Date

1994-01-31

74330 / 1

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

74330

Product Number

1

Dosage Form

-

Strength

180MG

Approval Date

1994-01-31

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83035

Drug Name

VITAMIN A

Product Number

1

Dosage Form

-

Strength

EQ 50,000 UNITS BASE

Approval Date

1982-01-01

83035 / 1

Active Ingredient

VITAMIN A PALMITATE

Application Number

83035

Product Number

1

Dosage Form

-

Strength

EQ 50,000 UNITS BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83190

Drug Name

VITAMIN A

Product Number

1

Dosage Form

-

Strength

EQ 50,000 UNITS BASE

Approval Date

1982-01-01

83190 / 1

Active Ingredient

VITAMIN A PALMITATE

Application Number

83190

Product Number

1

Dosage Form

-

Strength

EQ 50,000 UNITS BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

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Drug Status Breakdown
326 total
  • Discontinued
  • RX
  • OTC
  • Unclassified
Official Source

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

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FDA Approved Drug Record Details Preview

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

Drug Name

ACYCLOVIR

Application Number

74674

Product Number

1

Active Ingredient

ACYCLOVIR

Dosage Form

-

Strength

200MG

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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Searchable pharmaceutical data

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Organized FDA drug records

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