ANI Pharmaceuticals Inc
FDA Approved Drugs

ANI 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.

RX Discontinued Unclassified OTC
  • Total Records 450
  • Latest Approval Date Mar 27, 2026
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
450
View
Unclassified
1
View
Discontinued
331
View
OTC
2
View
RX
116
View
Company Overview

Company

ANI Pharmaceuticals Inc

Country

U.S.A

Website

Visit Website

Email

rob.schrepfer@anipharmaceuticals.com

Social Profiles

Company Snapshot

ANI Pharmaceuticals Inc

210 Main Street West Baudette, MN 56623

U.S.A

www.anipharmaceuticals.com/ rob.schrepfer@anipharmaceuticals.com View on Map
FDA Approved Drug Records ( 450 records )
1995
18 Oct
RX Application: 74007

Drug Name

ACEBUTOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

1995-10-18

74007 / 1

Active Ingredient

ACEBUTOLOL HYDROCHLORIDE

Application Number

74007

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

1995-10-18

Regulatory Status

RX

1995
18 Oct
RX Application: 74007

Drug Name

ACEBUTOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

1995-10-18

74007 / 2

Active Ingredient

ACEBUTOLOL HYDROCHLORIDE

Application Number

74007

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

1995-10-18

Regulatory Status

RX

1985
06 Mar
Discontinued Application: 88629

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

1985-03-06

88629 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

88629

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

1985-03-06

Regulatory Status

Discontinued

1985
06 Mar
Discontinued Application: 88629

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

2

Dosage Form

-

Strength

300MG;15MG

Approval Date

1985-03-06

88629 / 2

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

88629

Product Number

2

Dosage Form

-

Strength

300MG;15MG

Approval Date

1985-03-06

Regulatory Status

Discontinued

1985
06 Mar
Discontinued Application: 88629

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

3

Dosage Form

-

Strength

300MG;30MG

Approval Date

1985-03-06

88629 / 3

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

88629

Product Number

3

Dosage Form

-

Strength

300MG;30MG

Approval Date

1985-03-06

Regulatory Status

Discontinued

1987
09 Feb
Discontinued Application: 70870

Drug Name

ACETOHEXAMIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1987-02-09

70870 / 1

Active Ingredient

ACETOHEXAMIDE

Application Number

70870

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1987-02-09

Regulatory Status

Discontinued

1987
09 Feb
Discontinued Application: 70870

Drug Name

ACETOHEXAMIDE

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

1987-02-09

70870 / 2

Active Ingredient

ACETOHEXAMIDE

Application Number

70870

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

1987-02-09

Regulatory Status

Discontinued

1994
16 Feb
Discontinued Application: 74085

Drug Name

ALPRAZOLAM

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

1994-02-16

74085 / 1

Active Ingredient

ALPRAZOLAM

Application Number

74085

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

1994-02-16

Regulatory Status

Discontinued

1994
16 Feb
Discontinued Application: 74085

Drug Name

ALPRAZOLAM

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1994-02-16

74085 / 2

Active Ingredient

ALPRAZOLAM

Application Number

74085

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1994-02-16

Regulatory Status

Discontinued

1994
16 Feb
Discontinued Application: 74085

Drug Name

ALPRAZOLAM

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

1994-02-16

74085 / 3

Active Ingredient

ALPRAZOLAM

Application Number

74085

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

1994-02-16

Regulatory Status

Discontinued

1996
26 Feb
Discontinued Application: 74085

Drug Name

ALPRAZOLAM

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

1996-02-26

74085 / 4

Active Ingredient

ALPRAZOLAM

Application Number

74085

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

1996-02-26

Regulatory Status

Discontinued

2006
31 Jul
Discontinued Application: 77725

Drug Name

ALPRAZOLAM

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2006-07-31

77725 / 1

Active Ingredient

ALPRAZOLAM

Application Number

77725

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2006-07-31

Regulatory Status

Discontinued

2006
31 Jul
Discontinued Application: 77725

Drug Name

ALPRAZOLAM

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2006-07-31

77725 / 2

Active Ingredient

ALPRAZOLAM

Application Number

77725

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2006-07-31

Regulatory Status

Discontinued

2006
31 Jul
Discontinued Application: 77725

Drug Name

ALPRAZOLAM

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2006-07-31

77725 / 3

Active Ingredient

ALPRAZOLAM

Application Number

77725

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2006-07-31

Regulatory Status

Discontinued

2006
31 Jul
Discontinued Application: 77725

Drug Name

ALPRAZOLAM

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2006-07-31

77725 / 4

Active Ingredient

ALPRAZOLAM

Application Number

77725

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2006-07-31

Regulatory Status

Discontinued

2007
28 Feb
Discontinued Application: 77979

Drug Name

ALPRAZOLAM

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2007-02-28

77979 / 1

Active Ingredient

ALPRAZOLAM

Application Number

77979

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2007-02-28

Regulatory Status

Discontinued

2007
28 Feb
Discontinued Application: 77979

Drug Name

ALPRAZOLAM

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2007-02-28

77979 / 2

Active Ingredient

ALPRAZOLAM

Application Number

77979

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2007-02-28

Regulatory Status

Discontinued

2007
28 Feb
Discontinued Application: 77979

Drug Name

ALPRAZOLAM

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2007-02-28

77979 / 3

Active Ingredient

ALPRAZOLAM

Application Number

77979

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2007-02-28

Regulatory Status

Discontinued

2007
28 Feb
Discontinued Application: 77979

Drug Name

ALPRAZOLAM

Product Number

4

Dosage Form

-

Strength

3MG

Approval Date

2007-02-28

77979 / 4

Active Ingredient

ALPRAZOLAM

Application Number

77979

Product Number

4

Dosage Form

-

Strength

3MG

Approval Date

2007-02-28

Regulatory Status

Discontinued

2020
14 Dec
Discontinued Application: 211629

Drug Name

AMINOCAPROIC ACID

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2020-12-14

211629 / 1

Active Ingredient

AMINOCAPROIC ACID

Application Number

211629

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2020-12-14

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85261

Drug Name

AMINOPHYLLINE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

85261 / 2

Active Ingredient

AMINOPHYLLINE

Application Number

85261

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85261

Drug Name

AMINOPHYLLINE

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

85261 / 4

Active Ingredient

AMINOPHYLLINE

Application Number

85261

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85031

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

85031 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

85031

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85031

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

85031 / 2

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

85031

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85031

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

85031 / 3

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

85031

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85031

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

1982-01-01

85031 / 4

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

85031

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

-
Unclassified Application: 85032

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

85032 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

85032

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

1995
27 Dec
RX Application: 20541

Drug Name

ARIMIDEX

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1995-12-27

20541 / 1

Active Ingredient

ANASTROZOLE

Application Number

20541

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1995-12-27

Regulatory Status

RX

2017
18 Jan
Discontinued Application: 206964

Drug Name

ASPIRIN AND DIPYRIDAMOLE

Product Number

1

Dosage Form

-

Strength

25MG;200MG

Approval Date

2017-01-18

206964 / 1

Active Ingredient

ASPIRIN; DIPYRIDAMOLE

Application Number

206964

Product Number

1

Dosage Form

-

Strength

25MG;200MG

Approval Date

2017-01-18

Regulatory Status

Discontinued

1998
04 Jun
RX Application: 20838

Drug Name

ATACAND

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1998-06-04

20838 / 1

Active Ingredient

CANDESARTAN CILEXETIL

Application Number

20838

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1998-06-04

Regulatory Status

RX

1998
04 Jun
RX Application: 20838

Drug Name

ATACAND

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

1998-06-04

20838 / 2

Active Ingredient

CANDESARTAN CILEXETIL

Application Number

20838

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

1998-06-04

Regulatory Status

RX

1998
04 Jun
RX Application: 20838

Drug Name

ATACAND

Product Number

3

Dosage Form

-

Strength

16MG

Approval Date

1998-06-04

20838 / 3

Active Ingredient

CANDESARTAN CILEXETIL

Application Number

20838

Product Number

3

Dosage Form

-

Strength

16MG

Approval Date

1998-06-04

Regulatory Status

RX

1998
04 Jun
RX Application: 20838

Drug Name

ATACAND

Product Number

4

Dosage Form

-

Strength

32MG

Approval Date

1998-06-04

20838 / 4

Active Ingredient

CANDESARTAN CILEXETIL

Application Number

20838

Product Number

4

Dosage Form

-

Strength

32MG

Approval Date

1998-06-04

Regulatory Status

RX

2000
05 Sep
RX Application: 21093

Drug Name

ATACAND HCT

Product Number

1

Dosage Form

-

Strength

16MG;12.5MG

Approval Date

2000-09-05

21093 / 1

Active Ingredient

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Application Number

21093

Product Number

1

Dosage Form

-

Strength

16MG;12.5MG

Approval Date

2000-09-05

Regulatory Status

RX

2000
05 Sep
RX Application: 21093

Drug Name

ATACAND HCT

Product Number

2

Dosage Form

-

Strength

32MG;12.5MG

Approval Date

2000-09-05

21093 / 2

Active Ingredient

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Application Number

21093

Product Number

2

Dosage Form

-

Strength

32MG;12.5MG

Approval Date

2000-09-05

Regulatory Status

RX

2008
16 May
RX Application: 21093

Drug Name

ATACAND HCT

Product Number

3

Dosage Form

-

Strength

32MG;25MG

Approval Date

2008-05-16

21093 / 3

Active Ingredient

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Application Number

21093

Product Number

3

Dosage Form

-

Strength

32MG;25MG

Approval Date

2008-05-16

Regulatory Status

RX

2023
08 Jun
RX Application: 217252

Drug Name

BACLOFEN

Product Number

1

Dosage Form

-

Strength

25MG/5ML

Approval Date

2023-06-08

217252 / 1

Active Ingredient

BACLOFEN

Application Number

217252

Product Number

1

Dosage Form

-

Strength

25MG/5ML

Approval Date

2023-06-08

Regulatory Status

RX

2004
11 Feb
RX Application: 76333

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-02-11

76333 / 1

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76333

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76333

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2004-02-11

76333 / 2

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76333

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76333

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2004-02-11

76333 / 3

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76333

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76333

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2004-02-11

76333 / 4

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76333

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76342

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2004-02-11

76342 / 1

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

76342

Product Number

1

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76342

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2004-02-11

76342 / 2

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

76342

Product Number

2

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76342

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2004-02-11

76342 / 3

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

76342

Product Number

3

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76342

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

4

Dosage Form

-

Strength

20MG;25MG

Approval Date

2004-02-11

76342 / 4

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

76342

Product Number

4

Dosage Form

-

Strength

20MG;25MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
Discontinued Application: 76348

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2004-02-11

76348 / 1

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

76348

Product Number

1

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2004-02-11

Regulatory Status

Discontinued

2004
11 Feb
Discontinued Application: 76348

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2004-02-11

76348 / 2

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

76348

Product Number

2

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2004-02-11

Regulatory Status

Discontinued

2004
11 Feb
Discontinued Application: 76348

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2004-02-11

76348 / 3

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

76348

Product Number

3

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2004-02-11

Regulatory Status

Discontinued

2004
11 Feb
Discontinued Application: 76348

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

4

Dosage Form

-

Strength

20MG;25MG

Approval Date

2004-02-11

76348 / 4

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

76348

Product Number

4

Dosage Form

-

Strength

20MG;25MG

Approval Date

2004-02-11

Regulatory Status

Discontinued

2018
08 May
RX Application: 209861

Drug Name

BEXAROTENE

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2018-05-08

209861 / 1

Active Ingredient

BEXAROTENE

Application Number

209861

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2018-05-08

Regulatory Status

RX

1982
01 Jan
RX Application: 17849

Drug Name

BRETHINE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1982-01-01

17849 / 1

Active Ingredient

TERBUTALINE SULFATE

Application Number

17849

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17849

Drug Name

BRETHINE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

17849 / 2

Active Ingredient

TERBUTALINE SULFATE

Application Number

17849

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

RX

2011
20 May
RX Application: 76697

Drug Name

CARBAMAZEPINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2011-05-20

76697 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

76697

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2011-05-20

Regulatory Status

RX

2011
20 May
RX Application: 76697

Drug Name

CARBAMAZEPINE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2011-05-20

76697 / 2

Active Ingredient

CARBAMAZEPINE

Application Number

76697

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2011-05-20

Regulatory Status

RX

2011
20 May
RX Application: 76697

Drug Name

CARBAMAZEPINE

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2011-05-20

76697 / 3

Active Ingredient

CARBAMAZEPINE

Application Number

76697

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2011-05-20

Regulatory Status

RX

2014
10 Mar
Discontinued Application: 203261

Drug Name

CARBIDOPA

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2014-03-10

203261 / 1

Active Ingredient

CARBIDOPA

Application Number

203261

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2014-03-10

Regulatory Status

Discontinued

1995
29 Jun
Discontinued Application: 73587

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

1

Dosage Form

-

Strength

25MG;100MG

Approval Date

1995-06-29

73587 / 1

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

73587

Product Number

1

Dosage Form

-

Strength

25MG;100MG

Approval Date

1995-06-29

Regulatory Status

Discontinued

1995
29 Jun
Discontinued Application: 73587

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

2

Dosage Form

-

Strength

10MG;100MG

Approval Date

1995-06-29

73587 / 2

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

73587

Product Number

2

Dosage Form

-

Strength

10MG;100MG

Approval Date

1995-06-29

Regulatory Status

Discontinued

1995
29 Jun
Discontinued Application: 73587

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

3

Dosage Form

-

Strength

25MG;250MG

Approval Date

1995-06-29

73587 / 3

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

73587

Product Number

3

Dosage Form

-

Strength

25MG;250MG

Approval Date

1995-06-29

Regulatory Status

Discontinued

2024
25 Jan
Discontinued Application: 215901

Drug Name

CARBOPROST TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/ML

Approval Date

2024-01-25

215901 / 1

Active Ingredient

CARBOPROST TROMETHAMINE

Application Number

215901

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/ML

Approval Date

2024-01-25

Regulatory Status

Discontinued

1995
04 Oct
RX Application: 20498

Drug Name

CASODEX

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1995-10-04

20498 / 1

Active Ingredient

BICALUTAMIDE

Application Number

20498

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1995-10-04

Regulatory Status

RX

1989
01 Mar
Discontinued Application: 62698

Drug Name

CEFADROXIL

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1989-03-01

62698 / 1

Active Ingredient

CEFADROXIL/CEFADROXIL HEMIHYDRATE

Application Number

62698

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1989-03-01

Regulatory Status

Discontinued

1989
01 Mar
Discontinued Application: 62698

Drug Name

CEFADROXIL

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1989-03-01

62698 / 2

Active Ingredient

CEFADROXIL/CEFADROXIL HEMIHYDRATE

Application Number

62698

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1989-03-01

Regulatory Status

Discontinued

1989
01 Mar
Discontinued Application: 62698

Drug Name

CEFADROXIL

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE/5ML

Approval Date

1989-03-01

62698 / 3

Active Ingredient

CEFADROXIL/CEFADROXIL HEMIHYDRATE

Application Number

62698

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE/5ML

Approval Date

1989-03-01

Regulatory Status

Discontinued

2006
20 Jan
Discontinued Application: 65278

Drug Name

CEFADROXIL

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

2006-01-20

65278 / 1

Active Ingredient

CEFADROXIL/CEFADROXIL HEMIHYDRATE

Application Number

65278

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

2006-01-20

Regulatory Status

Discontinued

2006
20 Jan
Discontinued Application: 65278

Drug Name

CEFADROXIL

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/5ML

Approval Date

2006-01-20

65278 / 2

Active Ingredient

CEFADROXIL/CEFADROXIL HEMIHYDRATE

Application Number

65278

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/5ML

Approval Date

2006-01-20

Regulatory Status

Discontinued

2004
18 Oct
Discontinued Application: 65190

Drug Name

CEFUROXIME AXETIL

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2004-10-18

65190 / 1

Active Ingredient

CEFUROXIME AXETIL

Application Number

65190

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2004-10-18

Regulatory Status

Discontinued

2004
18 Oct
Discontinued Application: 65190

Drug Name

CEFUROXIME AXETIL

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2004-10-18

65190 / 2

Active Ingredient

CEFUROXIME AXETIL

Application Number

65190

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2004-10-18

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87353

Drug Name

CHLORPROPAMIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

87353 / 1

Active Ingredient

CHLORPROPAMIDE

Application Number

87353

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
11 Oct
Discontinued Application: 88768

Drug Name

CHLORPROPAMIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1984-10-11

88768 / 1

Active Ingredient

CHLORPROPAMIDE

Application Number

88768

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1984-10-11

Regulatory Status

Discontinued

1984
19 Oct
Discontinued Application: 88812

Drug Name

CHLORPROPAMIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1984-10-19

88812 / 1

Active Ingredient

CHLORPROPAMIDE

Application Number

88812

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1984-10-19

Regulatory Status

Discontinued

1984
19 Oct
Discontinued Application: 88813

Drug Name

CHLORPROPAMIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1984-10-19

88813 / 1

Active Ingredient

CHLORPROPAMIDE

Application Number

88813

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1984-10-19

Regulatory Status

Discontinued

1984
26 Sep
Discontinued Application: 88826

Drug Name

CHLORPROPAMIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1984-09-26

88826 / 1

Active Ingredient

CHLORPROPAMIDE

Application Number

88826

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1984-09-26

Regulatory Status

Discontinued

1984
25 Oct
Discontinued Application: 88840

Drug Name

CHLORPROPAMIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1984-10-25

88840 / 1

Active Ingredient

CHLORPROPAMIDE

Application Number

88840

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1984-10-25

Regulatory Status

Discontinued

1984
16 Oct
Discontinued Application: 88918

Drug Name

CHLORPROPAMIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1984-10-16

88918 / 1

Active Ingredient

CHLORPROPAMIDE

Application Number

88918

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1984-10-16

Regulatory Status

Discontinued

1984
16 Oct
Discontinued Application: 88919

Drug Name

CHLORPROPAMIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1984-10-16

88919 / 1

Active Ingredient

CHLORPROPAMIDE

Application Number

88919

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1984-10-16

Regulatory Status

Discontinued

1985
12 Apr
Discontinued Application: 88921

Drug Name

CHLORPROPAMIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1985-04-12

88921 / 1

Active Ingredient

CHLORPROPAMIDE

Application Number

88921

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1985-04-12

Regulatory Status

Discontinued

1985
12 Apr
Discontinued Application: 88922

Drug Name

CHLORPROPAMIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1985-04-12

88922 / 1

Active Ingredient

CHLORPROPAMIDE

Application Number

88922

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1985-04-12

Regulatory Status

Discontinued

1986
17 Nov
Discontinued Application: 89446

Drug Name

CHLORPROPAMIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1986-11-17

89446 / 1

Active Ingredient

CHLORPROPAMIDE

Application Number

89446

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1986-11-17

Regulatory Status

Discontinued

1986
17 Nov
Discontinued Application: 89447

Drug Name

CHLORPROPAMIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1986-11-17

89447 / 1

Active Ingredient

CHLORPROPAMIDE

Application Number

89447

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1986-11-17

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87296

Drug Name

CHLORTHALIDONE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

87296 / 1

Active Ingredient

CHLORTHALIDONE

Application Number

87296

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87689

Drug Name

CHLORTHALIDONE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

87689 / 1

Active Ingredient

CHLORTHALIDONE

Application Number

87689

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87706

Drug Name

CHLORTHALIDONE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

87706 / 1

Active Ingredient

CHLORTHALIDONE

Application Number

87706

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
09 Jan
Discontinued Application: 88164

Drug Name

CHLORTHALIDONE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1984-01-09

88164 / 1

Active Ingredient

CHLORTHALIDONE

Application Number

88164

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1984-01-09

Regulatory Status

Discontinued

1996
02 Oct
Discontinued Application: 74554

Drug Name

CHOLESTYRAMINE

Product Number

1

Dosage Form

-

Strength

EQ 4GM RESIN/PACKET

Approval Date

1996-10-02

74554 / 1

Active Ingredient

CHOLESTYRAMINE

Application Number

74554

Product Number

1

Dosage Form

-

Strength

EQ 4GM RESIN/PACKET

Approval Date

1996-10-02

Regulatory Status

Discontinued

1996
02 Oct
Discontinued Application: 74554

Drug Name

CHOLESTYRAMINE

Product Number

2

Dosage Form

-

Strength

EQ 4GM RESIN/SCOOPFUL

Approval Date

1996-10-02

74554 / 2

Active Ingredient

CHOLESTYRAMINE

Application Number

74554

Product Number

2

Dosage Form

-

Strength

EQ 4GM RESIN/SCOOPFUL

Approval Date

1996-10-02

Regulatory Status

Discontinued

1996
26 Sep
Discontinued Application: 74610

Drug Name

CIMETIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/5ML

Approval Date

1996-09-26

74610 / 1

Active Ingredient

CIMETIDINE HYDROCHLORIDE

Application Number

74610

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/5ML

Approval Date

1996-09-26

Regulatory Status

Discontinued

1998
09 Jul
Discontinued Application: 74859

Drug Name

CIMETIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/5ML

Approval Date

1998-07-09

74859 / 1

Active Ingredient

CIMETIDINE HYDROCHLORIDE

Application Number

74859

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/5ML

Approval Date

1998-07-09

Regulatory Status

Discontinued

1998
18 Jun
Discontinued Application: 75110

Drug Name

CIMETIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/5ML

Approval Date

1998-06-18

75110 / 1

Active Ingredient

CIMETIDINE HYDROCHLORIDE

Application Number

75110

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/5ML

Approval Date

1998-06-18

Regulatory Status

Discontinued

2010
30 Nov
Discontinued Application: 77809

Drug Name

CIPROFLOXACIN EXTENDED RELEASE

Product Number

1

Dosage Form

-

Strength

425.2MG;EQ 574.9MG BASE

Approval Date

2010-11-30

77809 / 1

Active Ingredient

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

Application Number

77809

Product Number

1

Dosage Form

-

Strength

425.2MG;EQ 574.9MG BASE

Approval Date

2010-11-30

Regulatory Status

Discontinued

2010
30 Nov
Discontinued Application: 77809

Drug Name

CIPROFLOXACIN EXTENDED RELEASE

Product Number

2

Dosage Form

-

Strength

212.6MG;EQ 287.5MG BASE

Approval Date

2010-11-30

77809 / 2

Active Ingredient

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

Application Number

77809

Product Number

2

Dosage Form

-

Strength

212.6MG;EQ 287.5MG BASE

Approval Date

2010-11-30

Regulatory Status

Discontinued

2005
25 Aug
Discontinued Application: 65250

Drug Name

CLARITHROMYCIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2005-08-25

65250 / 1

Active Ingredient

CLARITHROMYCIN

Application Number

65250

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2005-08-25

Regulatory Status

Discontinued

1992
31 Jan
Discontinued Application: 73282

Drug Name

CLEMASTINE FUMARATE

Product Number

1

Dosage Form

-

Strength

1.34MG

Approval Date

1992-01-31

73282 / 1

Active Ingredient

CLEMASTINE FUMARATE

Application Number

73282

Product Number

1

Dosage Form

-

Strength

1.34MG

Approval Date

1992-01-31

Regulatory Status

Discontinued

1992
03 Dec
Discontinued Application: 73282

Drug Name

CLEMASTINE FUMARATE

Product Number

2

Dosage Form

-

Strength

1.34MG

Approval Date

1992-12-03

73282 / 2

Active Ingredient

CLEMASTINE FUMARATE

Application Number

73282

Product Number

2

Dosage Form

-

Strength

1.34MG

Approval Date

1992-12-03

Regulatory Status

Discontinued

2001
22 Aug
Discontinued Application: 75733

Drug Name

CLOBETASOL PROPIONATE (EMOLLIENT)

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2001-08-22

75733 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

75733

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2001-08-22

Regulatory Status

Discontinued

2012
17 May
Discontinued Application: 90625

Drug Name

CLOPIDOGREL BISULFATE

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2012-05-17

90625 / 1

Active Ingredient

CLOPIDOGREL BISULFATE

Application Number

90625

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2012-05-17

Regulatory Status

Discontinued

2012
17 May
Discontinued Application: 91216

Drug Name

CLOPIDOGREL BISULFATE

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2012-05-17

91216 / 1

Active Ingredient

CLOPIDOGREL BISULFATE

Application Number

91216

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2012-05-17

Regulatory Status

Discontinued

2023
10 Mar
RX Application: 216517

Drug Name

COLESTIPOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2023-03-10

216517 / 1

Active Ingredient

COLESTIPOL HYDROCHLORIDE

Application Number

216517

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2023-03-10

Regulatory Status

RX

1982
01 Jan
RX Application: 16199

Drug Name

CORTENEMA

Product Number

1

Dosage Form

-

Strength

100MG/60ML

Approval Date

1982-01-01

16199 / 1

Active Ingredient

HYDROCORTISONE

Application Number

16199

Product Number

1

Dosage Form

-

Strength

100MG/60ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 9854

Drug Name

CORTROPHIN-ZINC

Product Number

1

Dosage Form

-

Strength

40 UNITS/ML

Approval Date

1982-01-01

9854 / 1

Active Ingredient

CORTICOTROPIN-ZINC HYDROXIDE

Application Number

9854

Product Number

1

Dosage Form

-

Strength

40 UNITS/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2018
19 Mar
Discontinued Application: 207014

Drug Name

CYCLOPHOSPHAMIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2018-03-19

207014 / 1

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

207014

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2018-03-19

Regulatory Status

Discontinued

2018
19 Mar
Discontinued Application: 207014

Drug Name

CYCLOPHOSPHAMIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2018-03-19

207014 / 2

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

207014

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2018-03-19

Regulatory Status

Discontinued

1997
29 May
Discontinued Application: 71803

Drug Name

DESIPRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1997-05-29

71803 / 1

Active Ingredient

DESIPRAMINE HYDROCHLORIDE

Application Number

71803

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1997-05-29

Regulatory Status

Discontinued

1987
08 Dec
Discontinued Application: 71803

Drug Name

DESIPRAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1987-12-08

71803 / 2

Active Ingredient

DESIPRAMINE HYDROCHLORIDE

Application Number

71803

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1987-12-08

Regulatory Status

Discontinued

1987
08 Dec
Discontinued Application: 71803

Drug Name

DESIPRAMINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1987-12-08

71803 / 3

Active Ingredient

DESIPRAMINE HYDROCHLORIDE

Application Number

71803

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1987-12-08

Regulatory Status

Discontinued

1987
08 Dec
Discontinued Application: 71803

Drug Name

DESIPRAMINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

1987-12-08

71803 / 4

Active Ingredient

DESIPRAMINE HYDROCHLORIDE

Application Number

71803

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

1987-12-08

Regulatory Status

Discontinued

1997
29 May
Discontinued Application: 71803

Drug Name

DESIPRAMINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

1997-05-29

71803 / 5

Active Ingredient

DESIPRAMINE HYDROCHLORIDE

Application Number

71803

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

1997-05-29

Regulatory Status

Discontinued

2016
28 Oct
Discontinued Application: 205153

Drug Name

DESIPRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2016-10-28

205153 / 1

Active Ingredient

DESIPRAMINE HYDROCHLORIDE

Application Number

205153

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2016-10-28

Regulatory Status

Discontinued

2016
28 Oct
Discontinued Application: 205153

Drug Name

DESIPRAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2016-10-28

205153 / 2

Active Ingredient

DESIPRAMINE HYDROCHLORIDE

Application Number

205153

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2016-10-28

Regulatory Status

Discontinued

2016
28 Oct
Discontinued Application: 205153

Drug Name

DESIPRAMINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2016-10-28

205153 / 3

Active Ingredient

DESIPRAMINE HYDROCHLORIDE

Application Number

205153

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2016-10-28

Regulatory Status

Discontinued

2016
28 Oct
Discontinued Application: 205153

Drug Name

DESIPRAMINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

2016-10-28

205153 / 4

Active Ingredient

DESIPRAMINE HYDROCHLORIDE

Application Number

205153

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

2016-10-28

Regulatory Status

Discontinued

2016
28 Oct
Discontinued Application: 205153

Drug Name

DESIPRAMINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

2016-10-28

205153 / 5

Active Ingredient

DESIPRAMINE HYDROCHLORIDE

Application Number

205153

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

2016-10-28

Regulatory Status

Discontinued

2016
28 Oct
Discontinued Application: 205153

Drug Name

DESIPRAMINE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

150MG

Approval Date

2016-10-28

205153 / 6

Active Ingredient

DESIPRAMINE HYDROCHLORIDE

Application Number

205153

Product Number

6

Dosage Form

-

Strength

150MG

Approval Date

2016-10-28

Regulatory Status

Discontinued

1986
17 Jan
Discontinued Application: 88682

Drug Name

DEXCHLORPHENIRAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1986-01-17

88682 / 1

Active Ingredient

DEXCHLORPHENIRAMINE MALEATE

Application Number

88682

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1986-01-17

Regulatory Status

Discontinued

2019
22 Jan
RX Application: 205401

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2019-01-22

205401 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

205401

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2019-01-22

Regulatory Status

RX

2019
22 Jan
RX Application: 205401

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

2

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2019-01-22

205401 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

205401

Product Number

2

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2019-01-22

Regulatory Status

RX

2019
22 Jan
RX Application: 205401

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

3

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2019-01-22

205401 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

205401

Product Number

3

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2019-01-22

Regulatory Status

RX

2019
22 Jan
RX Application: 205401

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

4

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2019-01-22

205401 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

205401

Product Number

4

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2019-01-22

Regulatory Status

RX

2019
22 Jan
RX Application: 205401

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

5

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2019-01-22

205401 / 5

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

205401

Product Number

5

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2019-01-22

Regulatory Status

RX

2019
22 Jan
RX Application: 205401

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

6

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2019-01-22

205401 / 6

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

205401

Product Number

6

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2019-01-22

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 85370

Drug Name

DEXTROAMPHETAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

85370 / 1

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

85370

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2002
20 Dec
Discontinued Application: 76263

Drug Name

DIFLORASONE DIACETATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2002-12-20

76263 / 1

Active Ingredient

DIFLORASONE DIACETATE

Application Number

76263

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2002-12-20

Regulatory Status

Discontinued

1996
10 Jun
Discontinued Application: 74604

Drug Name

DIFLUNISAL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1996-06-10

74604 / 1

Active Ingredient

DIFLUNISAL

Application Number

74604

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1996-06-10

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 86727

Drug Name

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Product Number

1

Dosage Form

-

Strength

0.025MG;2.5MG

Approval Date

1982-01-01

86727 / 1

Active Ingredient

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

Application Number

86727

Product Number

1

Dosage Form

-

Strength

0.025MG;2.5MG

Approval Date

1982-01-01

Regulatory Status

RX

1992
25 Feb
Discontinued Application: 86944

Drug Name

DIPYRIDAMOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1992-02-25

86944 / 1

Active Ingredient

DIPYRIDAMOLE

Application Number

86944

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1992-02-25

Regulatory Status

Discontinued

1991
16 Apr
Discontinued Application: 86944

Drug Name

DIPYRIDAMOLE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1991-04-16

86944 / 2

Active Ingredient

DIPYRIDAMOLE

Application Number

86944

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1991-04-16

Regulatory Status

Discontinued

1992
25 Feb
Discontinued Application: 86944

Drug Name

DIPYRIDAMOLE

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1992-02-25

86944 / 3

Active Ingredient

DIPYRIDAMOLE

Application Number

86944

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1992-02-25

Regulatory Status

Discontinued

2000
18 Oct
Discontinued Application: 75432

Drug Name

DOXAZOSIN MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2000-10-18

75432 / 1

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75432

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2000-10-18

Regulatory Status

Discontinued

2000
18 Oct
Discontinued Application: 75432

Drug Name

DOXAZOSIN MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2000-10-18

75432 / 2

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75432

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2000-10-18

Regulatory Status

Discontinued

2000
18 Oct
Discontinued Application: 75432

Drug Name

DOXAZOSIN MESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2000-10-18

75432 / 3

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75432

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2000-10-18

Regulatory Status

Discontinued

2000
18 Oct
Discontinued Application: 75432

Drug Name

DOXAZOSIN MESYLATE

Product Number

4

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2000-10-18

75432 / 4

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75432

Product Number

4

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2000-10-18

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 62055

Drug Name

ERYTHROMYCIN ETHYLSUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

1982-01-01

62055 / 1

Active Ingredient

ERYTHROMYCIN ETHYLSUCCINATE

Application Number

62055

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

RX

2018
02 Nov
RX Application: 62055

Drug Name

ERYTHROMYCIN ETHYLSUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE/5ML

Approval Date

2018-11-02

62055 / 2

Active Ingredient

ERYTHROMYCIN ETHYLSUCCINATE

Application Number

62055

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE/5ML

Approval Date

2018-11-02

Regulatory Status

RX

2018
02 Nov
RX Application: 62055

Drug Name

ERYTHROMYCIN ETHYLSUCCINATE

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

2018-11-02

62055 / 3

Active Ingredient

ERYTHROMYCIN ETHYLSUCCINATE

Application Number

62055

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

2018-11-02

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 61461

Drug Name

ERYTHROMYCIN STEARATE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

61461 / 1

Active Ingredient

ERYTHROMYCIN STEARATE

Application Number

61461

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61461

Drug Name

ERYTHROMYCIN STEARATE

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

61461 / 2

Active Ingredient

ERYTHROMYCIN STEARATE

Application Number

61461

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61591

Drug Name

ERYTHROMYCIN STEARATE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

61591 / 1

Active Ingredient

ERYTHROMYCIN STEARATE

Application Number

61591

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1990
15 May
Discontinued Application: 63179

Drug Name

ERYTHROMYCIN STEARATE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1990-05-15

63179 / 1

Active Ingredient

ERYTHROMYCIN STEARATE

Application Number

63179

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1990-05-15

Regulatory Status

Discontinued

1997
29 Aug
Discontinued Application: 74840

Drug Name

ETODOLAC

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-08-29

74840 / 1

Active Ingredient

ETODOLAC

Application Number

74840

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-08-29

Regulatory Status

Discontinued

1997
29 Aug
Discontinued Application: 74840

Drug Name

ETODOLAC

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1997-08-29

74840 / 2

Active Ingredient

ETODOLAC

Application Number

74840

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1997-08-29

Regulatory Status

Discontinued

1997
23 Dec
Discontinued Application: 74844

Drug Name

ETODOLAC

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-12-23

74844 / 1

Active Ingredient

ETODOLAC

Application Number

74844

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-12-23

Regulatory Status

Discontinued

1997
23 Dec
Discontinued Application: 74844

Drug Name

ETODOLAC

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1997-12-23

74844 / 2

Active Ingredient

ETODOLAC

Application Number

74844

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1997-12-23

Regulatory Status

Discontinued

1997
08 Jul
Discontinued Application: 74899

Drug Name

ETODOLAC

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-07-08

74899 / 1

Active Ingredient

ETODOLAC

Application Number

74899

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-07-08

Regulatory Status

Discontinued

1997
08 Jul
Discontinued Application: 74899

Drug Name

ETODOLAC

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1997-07-08

74899 / 2

Active Ingredient

ETODOLAC

Application Number

74899

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1997-07-08

Regulatory Status

Discontinued

1999
16 Sep
RX Application: 75126

Drug Name

ETODOLAC

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1999-09-16

75126 / 1

Active Ingredient

ETODOLAC

Application Number

75126

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1999-09-16

Regulatory Status

RX

1999
16 Sep
RX Application: 75126

Drug Name

ETODOLAC

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1999-09-16

75126 / 2

Active Ingredient

ETODOLAC

Application Number

75126

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1999-09-16

Regulatory Status

RX

2002
26 Jul
Discontinued Application: 75943

Drug Name

ETODOLAC

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2002-07-26

75943 / 1

Active Ingredient

ETODOLAC

Application Number

75943

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2002-07-26

Regulatory Status

Discontinued

2002
26 Jul
Discontinued Application: 75943

Drug Name

ETODOLAC

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2002-07-26

75943 / 2

Active Ingredient

ETODOLAC

Application Number

75943

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2002-07-26

Regulatory Status

Discontinued

2002
26 Jul
Discontinued Application: 75943

Drug Name

ETODOLAC

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2002-07-26

75943 / 3

Active Ingredient

ETODOLAC

Application Number

75943

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2002-07-26

Regulatory Status

Discontinued

2003
20 Jun
Discontinued Application: 40435

Drug Name

EXTENDED PHENYTOIN SODIUM

Product Number

1

Dosage Form

-

Strength

100MG EXTENDED

Approval Date

2003-06-20

40435 / 1

Active Ingredient

PHENYTOIN SODIUM

Application Number

40435

Product Number

1

Dosage Form

-

Strength

100MG EXTENDED

Approval Date

2003-06-20

Regulatory Status

Discontinued

1986
18 Dec
Discontinued Application: 89441

Drug Name

EXTENDED PHENYTOIN SODIUM

Product Number

1

Dosage Form

-

Strength

100MG EXTENDED

Approval Date

1986-12-18

89441 / 1

Active Ingredient

PHENYTOIN SODIUM

Application Number

89441

Product Number

1

Dosage Form

-

Strength

100MG EXTENDED

Approval Date

1986-12-18

Regulatory Status

Discontinued

2017
26 Apr
Discontinued Application: 201890

Drug Name

EZETIMIBE AND SIMVASTATIN

Product Number

1

Dosage Form

-

Strength

10MG;10MG

Approval Date

2017-04-26

201890 / 1

Active Ingredient

EZETIMIBE; SIMVASTATIN

Application Number

201890

Product Number

1

Dosage Form

-

Strength

10MG;10MG

Approval Date

2017-04-26

Regulatory Status

Discontinued

2017
26 Apr
Discontinued Application: 201890

Drug Name

EZETIMIBE AND SIMVASTATIN

Product Number

2

Dosage Form

-

Strength

10MG;20MG

Approval Date

2017-04-26

201890 / 2

Active Ingredient

EZETIMIBE; SIMVASTATIN

Application Number

201890

Product Number

2

Dosage Form

-

Strength

10MG;20MG

Approval Date

2017-04-26

Regulatory Status

Discontinued

2017
26 Apr
Discontinued Application: 201890

Drug Name

EZETIMIBE AND SIMVASTATIN

Product Number

3

Dosage Form

-

Strength

10MG;40MG

Approval Date

2017-04-26

201890 / 3

Active Ingredient

EZETIMIBE; SIMVASTATIN

Application Number

201890

Product Number

3

Dosage Form

-

Strength

10MG;40MG

Approval Date

2017-04-26

Regulatory Status

Discontinued

2017
26 Apr
Discontinued Application: 201890

Drug Name

EZETIMIBE AND SIMVASTATIN

Product Number

4

Dosage Form

-

Strength

10MG;80MG

Approval Date

2017-04-26

201890 / 4

Active Ingredient

EZETIMIBE; SIMVASTATIN

Application Number

201890

Product Number

4

Dosage Form

-

Strength

10MG;80MG

Approval Date

2017-04-26

Regulatory Status

Discontinued

2015
04 Nov
RX Application: 202284

Drug Name

FELBAMATE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2015-11-04

202284 / 1

Active Ingredient

FELBAMATE

Application Number

202284

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2015-11-04

Regulatory Status

RX

2015
04 Nov
RX Application: 202284

Drug Name

FELBAMATE

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2015-11-04

202284 / 2

Active Ingredient

FELBAMATE

Application Number

202284

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2015-11-04

Regulatory Status

RX

2018
30 Apr
RX Application: 209504

Drug Name

FENOFIBRATE (MICRONIZED)

Product Number

1

Dosage Form

-

Strength

67MG

Approval Date

2018-04-30

209504 / 1

Active Ingredient

FENOFIBRATE

Application Number

209504

Product Number

1

Dosage Form

-

Strength

67MG

Approval Date

2018-04-30

Regulatory Status

RX

2018
30 Apr
RX Application: 209504

Drug Name

FENOFIBRATE (MICRONIZED)

Product Number

2

Dosage Form

-

Strength

134MG

Approval Date

2018-04-30

209504 / 2

Active Ingredient

FENOFIBRATE

Application Number

209504

Product Number

2

Dosage Form

-

Strength

134MG

Approval Date

2018-04-30

Regulatory Status

RX

2018
30 Apr
RX Application: 209504

Drug Name

FENOFIBRATE (MICRONIZED)

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2018-04-30

209504 / 3

Active Ingredient

FENOFIBRATE

Application Number

209504

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2018-04-30

Regulatory Status

RX

1988
02 May
Discontinued Application: 72274

Drug Name

FENOPROFEN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE

Approval Date

1988-05-02

72274 / 1

Active Ingredient

FENOPROFEN CALCIUM

Application Number

72274

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE

Approval Date

1988-05-02

Regulatory Status

Discontinued

2023
04 Jan
Discontinued Application: 204504

Drug Name

FESOTERODINE FUMARATE

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2023-01-04

204504 / 1

Active Ingredient

FESOTERODINE FUMARATE

Application Number

204504

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2023-01-04

Regulatory Status

Discontinued

2023
04 Jan
Discontinued Application: 204504

Drug Name

FESOTERODINE FUMARATE

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2023-01-04

204504 / 2

Active Ingredient

FESOTERODINE FUMARATE

Application Number

204504

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2023-01-04

Regulatory Status

Discontinued

2002
28 Oct
RX Application: 75882

Drug Name

FLECAINIDE ACETATE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-10-28

75882 / 1

Active Ingredient

FLECAINIDE ACETATE

Application Number

75882

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-10-28

Regulatory Status

RX

2002
28 Oct
RX Application: 75882

Drug Name

FLECAINIDE ACETATE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2002-10-28

75882 / 2

Active Ingredient

FLECAINIDE ACETATE

Application Number

75882

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2002-10-28

Regulatory Status

RX

2002
28 Oct
RX Application: 75882

Drug Name

FLECAINIDE ACETATE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2002-10-28

75882 / 3

Active Ingredient

FLECAINIDE ACETATE

Application Number

75882

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2002-10-28

Regulatory Status

RX

2002
28 Oct
Discontinued Application: 76030

Drug Name

FLECAINIDE ACETATE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-10-28

76030 / 1

Active Ingredient

FLECAINIDE ACETATE

Application Number

76030

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-10-28

Regulatory Status

Discontinued

2002
28 Oct
Discontinued Application: 76030

Drug Name

FLECAINIDE ACETATE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2002-10-28

76030 / 2

Active Ingredient

FLECAINIDE ACETATE

Application Number

76030

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2002-10-28

Regulatory Status

Discontinued

2002
28 Oct
Discontinued Application: 76030

Drug Name

FLECAINIDE ACETATE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2002-10-28

76030 / 3

Active Ingredient

FLECAINIDE ACETATE

Application Number

76030

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2002-10-28

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76086

Drug Name

FLUCONAZOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-07-29

76086 / 1

Active Ingredient

FLUCONAZOLE

Application Number

76086

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76086

Drug Name

FLUCONAZOLE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2004-07-29

76086 / 2

Active Ingredient

FLUCONAZOLE

Application Number

76086

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76086

Drug Name

FLUCONAZOLE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2004-07-29

76086 / 3

Active Ingredient

FLUCONAZOLE

Application Number

76086

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76086

Drug Name

FLUCONAZOLE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2004-07-29

76086 / 4

Active Ingredient

FLUCONAZOLE

Application Number

76086

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2011
07 Mar
RX Application: 78423

Drug Name

FLUCONAZOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2011-03-07

78423 / 1

Active Ingredient

FLUCONAZOLE

Application Number

78423

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2011-03-07

Regulatory Status

RX

2011
07 Mar
RX Application: 78423

Drug Name

FLUCONAZOLE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2011-03-07

78423 / 2

Active Ingredient

FLUCONAZOLE

Application Number

78423

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2011-03-07

Regulatory Status

RX

2011
07 Mar
RX Application: 78423

Drug Name

FLUCONAZOLE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2011-03-07

78423 / 3

Active Ingredient

FLUCONAZOLE

Application Number

78423

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2011-03-07

Regulatory Status

RX

2011
07 Mar
RX Application: 78423

Drug Name

FLUCONAZOLE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2011-03-07

78423 / 4

Active Ingredient

FLUCONAZOLE

Application Number

78423

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2011-03-07

Regulatory Status

RX

2008
20 May
Discontinued Application: 76287

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2008-05-20

76287 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

76287

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2008-05-20

Regulatory Status

Discontinued

2008
20 May
Discontinued Application: 76287

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2008-05-20

76287 / 2

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

76287

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2008-05-20

Regulatory Status

Discontinued

1991
30 Aug
Discontinued Application: 73058

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1991-08-30

73058 / 1

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

73058

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1991-08-30

Regulatory Status

Discontinued

1993
29 Apr
Discontinued Application: 81310

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG/5ML

Approval Date

1993-04-29

81310 / 1

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

81310

Product Number

1

Dosage Form

-

Strength

2.5MG/5ML

Approval Date

1993-04-29

Regulatory Status

Discontinued

2001
25 Jan
Discontinued Application: 75897

Drug Name

FLUVOXAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2001-01-25

75897 / 1

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

75897

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2001-01-25

Regulatory Status

Discontinued

2001
25 Jan
Discontinued Application: 75897

Drug Name

FLUVOXAMINE MALEATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2001-01-25

75897 / 2

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

75897

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2001-01-25

Regulatory Status

Discontinued

2001
25 Jan
Discontinued Application: 75897

Drug Name

FLUVOXAMINE MALEATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2001-01-25

75897 / 3

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

75897

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2001-01-25

Regulatory Status

Discontinued

2001
12 Mar
Discontinued Application: 75898

Drug Name

FLUVOXAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2001-03-12

75898 / 1

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

75898

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2001-03-12

Regulatory Status

Discontinued

2001
12 Mar
Discontinued Application: 75898

Drug Name

FLUVOXAMINE MALEATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2001-03-12

75898 / 2

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

75898

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2001-03-12

Regulatory Status

Discontinued

2001
12 Mar
Discontinued Application: 75898

Drug Name

FLUVOXAMINE MALEATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2001-03-12

75898 / 3

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

75898

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2001-03-12

Regulatory Status

Discontinued

2004
03 Dec
Discontinued Application: 76608

Drug Name

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2004-12-03

76608 / 1

Active Ingredient

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

Application Number

76608

Product Number

1

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2004-12-03

Regulatory Status

Discontinued

2004
03 Dec
Discontinued Application: 76608

Drug Name

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2004-12-03

76608 / 2

Active Ingredient

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

Application Number

76608

Product Number

2

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2004-12-03

Regulatory Status

Discontinued

2005
16 Aug
Discontinued Application: 77144

Drug Name

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2005-08-16

77144 / 1

Active Ingredient

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

Application Number

77144

Product Number

1

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2005-08-16

Regulatory Status

Discontinued

2005
16 Aug
Discontinued Application: 77144

Drug Name

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2005-08-16

77144 / 2

Active Ingredient

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

Application Number

77144

Product Number

2

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2005-08-16

Regulatory Status

Discontinued

1986
26 Feb
Discontinued Application: 70413

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1986-02-26

70413 / 1

Active Ingredient

FUROSEMIDE

Application Number

70413

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1986-02-26

Regulatory Status

Discontinued

1987
02 Jan
Discontinued Application: 71379

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1987-01-02

71379 / 1

Active Ingredient

FUROSEMIDE

Application Number

71379

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1987-01-02

Regulatory Status

Discontinued

1988
09 Feb
Discontinued Application: 71594

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1988-02-09

71594 / 1

Active Ingredient

FUROSEMIDE

Application Number

71594

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1988-02-09

Regulatory Status

Discontinued

1996
04 Mar
Discontinued Application: 74387

Drug Name

GLIPIZIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1996-03-04

74387 / 1

Active Ingredient

GLIPIZIDE

Application Number

74387

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1996-03-04

Regulatory Status

Discontinued

1996
04 Mar
Discontinued Application: 74387

Drug Name

GLIPIZIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1996-03-04

74387 / 2

Active Ingredient

GLIPIZIDE

Application Number

74387

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1996-03-04

Regulatory Status

Discontinued

1995
31 Aug
RX Application: 74497

Drug Name

GLIPIZIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1995-08-31

74497 / 1

Active Ingredient

GLIPIZIDE

Application Number

74497

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1995-08-31

Regulatory Status

RX

1995
31 Aug
RX Application: 74497

Drug Name

GLIPIZIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1995-08-31

74497 / 2

Active Ingredient

GLIPIZIDE

Application Number

74497

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1995-08-31

Regulatory Status

RX

1984
11 Oct
Discontinued Application: 88641

Drug Name

GLUCAMIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1984-10-11

88641 / 1

Active Ingredient

CHLORPROPAMIDE

Application Number

88641

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1984-10-11

Regulatory Status

Discontinued

1995
07 Apr
Discontinued Application: 74149

Drug Name

GUANABENZ ACETATE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

1995-04-07

74149 / 1

Active Ingredient

GUANABENZ ACETATE

Application Number

74149

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

1995-04-07

Regulatory Status

Discontinued

1995
07 Apr
Discontinued Application: 74149

Drug Name

GUANABENZ ACETATE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

1995-04-07

74149 / 2

Active Ingredient

GUANABENZ ACETATE

Application Number

74149

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

1995-04-07

Regulatory Status

Discontinued

1994
01 Jun
Discontinued Application: 74267

Drug Name

GUANABENZ ACETATE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

1994-06-01

74267 / 1

Active Ingredient

GUANABENZ ACETATE

Application Number

74267

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

1994-06-01

Regulatory Status

Discontinued

1994
01 Jun
Discontinued Application: 74267

Drug Name

GUANABENZ ACETATE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

1994-06-01

74267 / 2

Active Ingredient

GUANABENZ ACETATE

Application Number

74267

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

1994-06-01

Regulatory Status

Discontinued

2010
23 Jun
Discontinued Application: 77454

Drug Name

HYDROCODONE BITARTRATE AND IBUPROFEN

Product Number

1

Dosage Form

-

Strength

5MG;200MG

Approval Date

2010-06-23

77454 / 1

Active Ingredient

HYDROCODONE BITARTRATE; IBUPROFEN

Application Number

77454

Product Number

1

Dosage Form

-

Strength

5MG;200MG

Approval Date

2010-06-23

Regulatory Status

Discontinued

1987
20 Jan
Discontinued Application: 71144

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1987-01-20

71144 / 1

Active Ingredient

IBUPROFEN

Application Number

71144

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1987-01-20

Regulatory Status

Discontinued

1991
19 Dec
Discontinued Application: 72901

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1991-12-19

72901 / 1

Active Ingredient

IBUPROFEN

Application Number

72901

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1991-12-19

Regulatory Status

Discontinued

1991
19 Dec
Discontinued Application: 72903

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1991-12-19

72903 / 1

Active Ingredient

IBUPROFEN

Application Number

72903

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1991-12-19

Regulatory Status

Discontinued

1995
27 Jul
RX Application: 74299

Drug Name

INDAPAMIDE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1995-07-27

74299 / 1

Active Ingredient

INDAPAMIDE

Application Number

74299

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1995-07-27

Regulatory Status

RX

1996
29 Apr
RX Application: 74299

Drug Name

INDAPAMIDE

Product Number

2

Dosage Form

-

Strength

1.25MG

Approval Date

1996-04-29

74299 / 2

Active Ingredient

INDAPAMIDE

Application Number

74299

Product Number

2

Dosage Form

-

Strength

1.25MG

Approval Date

1996-04-29

Regulatory Status

RX

1996
31 Oct
Discontinued Application: 74498

Drug Name

INDAPAMIDE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1996-10-31

74498 / 1

Active Ingredient

INDAPAMIDE

Application Number

74498

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1996-10-31

Regulatory Status

Discontinued

1998
12 Feb
Discontinued Application: 74498

Drug Name

INDAPAMIDE

Product Number

2

Dosage Form

-

Strength

1.25MG

Approval Date

1998-02-12

74498 / 2

Active Ingredient

INDAPAMIDE

Application Number

74498

Product Number

2

Dosage Form

-

Strength

1.25MG

Approval Date

1998-02-12

Regulatory Status

Discontinued

1998
04 Dec
Discontinued Application: 75201

Drug Name

INDAPAMIDE

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

1998-12-04

75201 / 1

Active Ingredient

INDAPAMIDE

Application Number

75201

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

1998-12-04

Regulatory Status

Discontinued

1998
04 Dec
Discontinued Application: 75201

Drug Name

INDAPAMIDE

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

1998-12-04

75201 / 2

Active Ingredient

INDAPAMIDE

Application Number

75201

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

1998-12-04

Regulatory Status

Discontinued

1983
19 Apr
RX Application: 18553

Drug Name

INDERAL LA

Product Number

1

Dosage Form

-

Strength

160MG

Approval Date

1983-04-19

18553 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

18553

Product Number

1

Dosage Form

-

Strength

160MG

Approval Date

1983-04-19

Regulatory Status

RX

1983
19 Apr
RX Application: 18553

Drug Name

INDERAL LA

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

1983-04-19

18553 / 2

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

18553

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

1983-04-19

Regulatory Status

RX

1983
19 Apr
RX Application: 18553

Drug Name

INDERAL LA

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

1983-04-19

18553 / 3

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

18553

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

1983-04-19

Regulatory Status

RX

1987
18 Mar
RX Application: 18553

Drug Name

INDERAL LA

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

1987-03-18

18553 / 4

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

18553

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

1987-03-18

Regulatory Status

RX

1987
18 Mar
Discontinued Application: 71148

Drug Name

INDOMETHACIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1987-03-18

71148 / 1

Active Ingredient

INDOMETHACIN

Application Number

71148

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1987-03-18

Regulatory Status

Discontinued

1987
18 Mar
Discontinued Application: 71149

Drug Name

INDOMETHACIN

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1987-03-18

71149 / 1

Active Ingredient

INDOMETHACIN

Application Number

71149

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1987-03-18

Regulatory Status

Discontinued

2003
12 Mar
RX Application: 21438

Drug Name

INNOPRAN XL

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2003-03-12

21438 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

21438

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2003-03-12

Regulatory Status

RX

2003
12 Mar
RX Application: 21438

Drug Name

INNOPRAN XL

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2003-03-12

21438 / 2

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

21438

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2003-03-12

Regulatory Status

RX

1988
07 Jan
Discontinued Application: 86032

Drug Name

ISOSORBIDE DINITRATE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1988-01-07

86032 / 1

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

86032

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1988-01-07

Regulatory Status

Discontinued

1998
27 Nov
RX Application: 75147

Drug Name

ISOSORBIDE MONONITRATE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1998-11-27

75147 / 1

Active Ingredient

ISOSORBIDE MONONITRATE

Application Number

75147

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1998-11-27

Regulatory Status

RX

2026
27 Mar
RX Application: 75147

Drug Name

ISOSORBIDE MONONITRATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-03-27

75147 / 2

Active Ingredient

ISOSORBIDE MONONITRATE

Application Number

75147

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-03-27

Regulatory Status

RX

2007
17 Sep
RX Application: 40028

Drug Name

KIONEX

Product Number

1

Dosage Form

-

Strength

15GM/60ML

Approval Date

2007-09-17

40028 / 1

Active Ingredient

SODIUM POLYSTYRENE SULFONATE

Application Number

40028

Product Number

1

Dosage Form

-

Strength

15GM/60ML

Approval Date

2007-09-17

Regulatory Status

RX

1998
06 Feb
RX Application: 40029

Drug Name

KIONEX

Product Number

1

Dosage Form

-

Strength

454GM/BOT

Approval Date

1998-02-06

40029 / 1

Active Ingredient

SODIUM POLYSTYRENE SULFONATE

Application Number

40029

Product Number

1

Dosage Form

-

Strength

454GM/BOT

Approval Date

1998-02-06

Regulatory Status

RX

2007
28 Nov
Discontinued Application: 78430

Drug Name

LACTULOSE

Product Number

1

Dosage Form

-

Strength

10GM/15ML

Approval Date

2007-11-28

78430 / 1

Active Ingredient

LACTULOSE

Application Number

78430

Product Number

1

Dosage Form

-

Strength

10GM/15ML

Approval Date

2007-11-28

Regulatory Status

Discontinued

2008
21 Nov
Discontinued Application: 90426

Drug Name

LACTULOSE

Product Number

1

Dosage Form

-

Strength

10GM/15ML

Approval Date

2008-11-21

90426 / 1

Active Ingredient

LACTULOSE

Application Number

90426

Product Number

1

Dosage Form

-

Strength

10GM/15ML

Approval Date

2008-11-21

Regulatory Status

Discontinued

2010
15 Oct
Discontinued Application: 78730

Drug Name

LANSOPRAZOLE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2010-10-15

78730 / 1

Active Ingredient

LANSOPRAZOLE

Application Number

78730

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2010-10-15

Regulatory Status

Discontinued

2010
15 Oct
Discontinued Application: 78730

Drug Name

LANSOPRAZOLE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2010-10-15

78730 / 2

Active Ingredient

LANSOPRAZOLE

Application Number

78730

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2010-10-15

Regulatory Status

Discontinued

2013
30 Aug
Discontinued Application: 200218

Drug Name

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)

Product Number

1

Dosage Form

-

Strength

500MG;500MG;30MG

Approval Date

2013-08-30

200218 / 1

Active Ingredient

AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE

Application Number

200218

Product Number

1

Dosage Form

-

Strength

500MG;500MG;30MG

Approval Date

2013-08-30

Regulatory Status

Discontinued

1999
24 Mar
Discontinued Application: 75327

Drug Name

LEUCOVORIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

1999-03-24

75327 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

75327

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

1999-03-24

Regulatory Status

Discontinued

2020
28 Oct
Discontinued Application: 211369

Drug Name

LEVOTHYROXINE SODIUM

Product Number

1

Dosage Form

-

Strength

0.075MG

Approval Date

2020-10-28

211369 / 1

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

211369

Product Number

1

Dosage Form

-

Strength

0.075MG

Approval Date

2020-10-28

Regulatory Status

Discontinued

2020
28 Oct
Discontinued Application: 211369

Drug Name

LEVOTHYROXINE SODIUM

Product Number

2

Dosage Form

-

Strength

0.15MG

Approval Date

2020-10-28

211369 / 2

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

211369

Product Number

2

Dosage Form

-

Strength

0.15MG

Approval Date

2020-10-28

Regulatory Status

Discontinued

2021
16 Apr
Discontinued Application: 211369

Drug Name

LEVOTHYROXINE SODIUM

Product Number

3

Dosage Form

-

Strength

0.112MG

Approval Date

2021-04-16

211369 / 3

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

211369

Product Number

3

Dosage Form

-

Strength

0.112MG

Approval Date

2021-04-16

Regulatory Status

Discontinued

2022
09 Nov
Discontinued Application: 211369

Drug Name

LEVOTHYROXINE SODIUM

Product Number

4

Dosage Form

-

Strength

0.2MG

Approval Date

2022-11-09

211369 / 4

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

211369

Product Number

4

Dosage Form

-

Strength

0.2MG

Approval Date

2022-11-09

Regulatory Status

Discontinued

2023
02 May
Discontinued Application: 211369

Drug Name

LEVOTHYROXINE SODIUM

Product Number

5

Dosage Form

-

Strength

0.137MG

Approval Date

2023-05-02

211369 / 5

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

211369

Product Number

5

Dosage Form

-

Strength

0.137MG

Approval Date

2023-05-02

Regulatory Status

Discontinued

2023
02 May
Discontinued Application: 211369

Drug Name

LEVOTHYROXINE SODIUM

Product Number

6

Dosage Form

-

Strength

0.175MG

Approval Date

2023-05-02

211369 / 6

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

211369

Product Number

6

Dosage Form

-

Strength

0.175MG

Approval Date

2023-05-02

Regulatory Status

Discontinued

2021
06 Jan
Discontinued Application: 213256

Drug Name

LEVOTHYROXINE SODIUM

Product Number

1

Dosage Form

-

Strength

0.088MG

Approval Date

2021-01-06

213256 / 1

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

213256

Product Number

1

Dosage Form

-

Strength

0.088MG

Approval Date

2021-01-06

Regulatory Status

Discontinued

2021
06 Jan
Discontinued Application: 213256

Drug Name

LEVOTHYROXINE SODIUM

Product Number

2

Dosage Form

-

Strength

0.1MG

Approval Date

2021-01-06

213256 / 2

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

213256

Product Number

2

Dosage Form

-

Strength

0.1MG

Approval Date

2021-01-06

Regulatory Status

Discontinued

2021
06 Jan
Discontinued Application: 213256

Drug Name

LEVOTHYROXINE SODIUM

Product Number

3

Dosage Form

-

Strength

0.125MG

Approval Date

2021-01-06

213256 / 3

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

213256

Product Number

3

Dosage Form

-

Strength

0.125MG

Approval Date

2021-01-06

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 18027

Drug Name

LITHOBID

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

18027 / 1

Active Ingredient

LITHIUM CARBONATE

Application Number

18027

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

Regulatory Status

RX

2006
13 Dec
RX Application: 77396

Drug Name

LORAZEPAM

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2006-12-13

77396 / 1

Active Ingredient

LORAZEPAM

Application Number

77396

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2006-12-13

Regulatory Status

RX

2006
13 Dec
RX Application: 77396

Drug Name

LORAZEPAM

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2006-12-13

77396 / 2

Active Ingredient

LORAZEPAM

Application Number

77396

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2006-12-13

Regulatory Status

RX

2006
13 Dec
RX Application: 77396

Drug Name

LORAZEPAM

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2006-12-13

77396 / 3

Active Ingredient

LORAZEPAM

Application Number

77396

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2006-12-13

Regulatory Status

RX

2007
20 Dec
RX Application: 21519

Drug Name

LUVOX

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2007-12-20

21519 / 1

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

21519

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2007-12-20

Regulatory Status

RX

2007
20 Dec
RX Application: 21519

Drug Name

LUVOX

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2007-12-20

21519 / 2

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

21519

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2007-12-20

Regulatory Status

RX

2007
20 Dec
RX Application: 21519

Drug Name

LUVOX

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2007-12-20

21519 / 3

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

21519

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2007-12-20

Regulatory Status

RX

2019
07 May
Discontinued Application: 209921

Drug Name

LUXZYLA

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2019-05-07

209921 / 1

Active Ingredient

PENICILLAMINE

Application Number

209921

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2019-05-07

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84657

Drug Name

MECLIZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

84657 / 1

Active Ingredient

MECLIZINE HYDROCHLORIDE

Application Number

84657

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84657

Drug Name

MECLIZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

12.5MG

Approval Date

1982-01-01

84657 / 2

Active Ingredient

MECLIZINE HYDROCHLORIDE

Application Number

84657

Product Number

2

Dosage Form

-

Strength

12.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85269

Drug Name

MECLIZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1982-01-01

85269 / 1

Active Ingredient

MECLIZINE HYDROCHLORIDE

Application Number

85269

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85740

Drug Name

MECLIZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

85740 / 1

Active Ingredient

MECLIZINE HYDROCHLORIDE

Application Number

85740

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985
11 Dec
Discontinued Application: 88732

Drug Name

MECLIZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1985-12-11

88732 / 1

Active Ingredient

MECLIZINE HYDROCHLORIDE

Application Number

88732

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1985-12-11

Regulatory Status

Discontinued

1987
15 Apr
Discontinued Application: 71469

Drug Name

MECLOFENAMATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1987-04-15

71469 / 1

Active Ingredient

MECLOFENAMATE SODIUM

Application Number

71469

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1987-04-15

Regulatory Status

Discontinued

1987
15 Apr
Discontinued Application: 71469

Drug Name

MECLOFENAMATE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1987-04-15

71469 / 2

Active Ingredient

MECLOFENAMATE SODIUM

Application Number

71469

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1987-04-15

Regulatory Status

Discontinued

2020
28 Feb
Discontinued Application: 205365

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

2020-02-28

205365 / 1

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

205365

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

2020-02-28

Regulatory Status

Discontinued

2020
28 Feb
Discontinued Application: 205365

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

2020-02-28

205365 / 2

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

205365

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

2020-02-28

Regulatory Status

Discontinued

2020
28 Feb
Discontinued Application: 205365

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

21MG

Approval Date

2020-02-28

205365 / 3

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

205365

Product Number

3

Dosage Form

-

Strength

21MG

Approval Date

2020-02-28

Regulatory Status

Discontinued

2020
28 Feb
Discontinued Application: 205365

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

28MG

Approval Date

2020-02-28

205365 / 4

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

205365

Product Number

4

Dosage Form

-

Strength

28MG

Approval Date

2020-02-28

Regulatory Status

Discontinued

2023
15 Dec
RX Application: 208237

Drug Name

MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG;21MG

Approval Date

2023-12-15

208237 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

Application Number

208237

Product Number

1

Dosage Form

-

Strength

10MG;21MG

Approval Date

2023-12-15

Regulatory Status

RX

1993
30 Jun
RX Application: 40001

Drug Name

METHAZOLAMIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1993-06-30

40001 / 1

Active Ingredient

METHAZOLAMIDE

Application Number

40001

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1993-06-30

Regulatory Status

RX

1993
30 Jun
RX Application: 40001

Drug Name

METHAZOLAMIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1993-06-30

40001 / 2

Active Ingredient

METHAZOLAMIDE

Application Number

40001

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1993-06-30

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 84276

Drug Name

METHOCARBAMOL

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

1982-01-01

84276 / 2

Active Ingredient

METHOCARBAMOL

Application Number

84276

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84277

Drug Name

METHOCARBAMOL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

84277 / 1

Active Ingredient

METHOCARBAMOL

Application Number

84277

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
08 Jun
Discontinued Application: 87781

Drug Name

METHOXSALEN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-06-08

87781 / 1

Active Ingredient

METHOXSALEN

Application Number

87781

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-06-08

Regulatory Status

Discontinued

2017
14 Jul
Discontinued Application: 208607

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

18MG

Approval Date

2017-07-14

208607 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

208607

Product Number

1

Dosage Form

-

Strength

18MG

Approval Date

2017-07-14

Regulatory Status

Discontinued

2017
14 Jul
Discontinued Application: 208607

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

27MG

Approval Date

2017-07-14

208607 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

208607

Product Number

2

Dosage Form

-

Strength

27MG

Approval Date

2017-07-14

Regulatory Status

Discontinued

2017
14 Jul
Discontinued Application: 208607

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

36MG

Approval Date

2017-07-14

208607 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

208607

Product Number

3

Dosage Form

-

Strength

36MG

Approval Date

2017-07-14

Regulatory Status

Discontinued

2017
14 Jul
Discontinued Application: 208607

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

54MG

Approval Date

2017-07-14

208607 / 4

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

208607

Product Number

4

Dosage Form

-

Strength

54MG

Approval Date

2017-07-14

Regulatory Status

Discontinued

1993
25 Jun
RX Application: 71402

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/5ML

Approval Date

1993-06-25

71402 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

71402

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/5ML

Approval Date

1993-06-25

Regulatory Status

RX

2004
06 Jan
Discontinued Application: 75543

Drug Name

METOLAZONE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2004-01-06

75543 / 1

Active Ingredient

METOLAZONE

Application Number

75543

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2004-01-06

Regulatory Status

Discontinued

2004
01 Mar
Discontinued Application: 75543

Drug Name

METOLAZONE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2004-03-01

75543 / 2

Active Ingredient

METOLAZONE

Application Number

75543

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2004-03-01

Regulatory Status

Discontinued

2003
24 Dec
Discontinued Application: 75543

Drug Name

METOLAZONE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2003-12-24

75543 / 3

Active Ingredient

METOLAZONE

Application Number

75543

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2003-12-24

Regulatory Status

Discontinued

1996
16 May
RX Application: 74450

Drug Name

MEXILETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1996-05-16

74450 / 1

Active Ingredient

MEXILETINE HYDROCHLORIDE

Application Number

74450

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1996-05-16

Regulatory Status

RX

1996
16 May
RX Application: 74450

Drug Name

MEXILETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1996-05-16

74450 / 2

Active Ingredient

MEXILETINE HYDROCHLORIDE

Application Number

74450

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1996-05-16

Regulatory Status

RX

1996
16 May
RX Application: 74450

Drug Name

MEXILETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

250MG

Approval Date

1996-05-16

74450 / 3

Active Ingredient

MEXILETINE HYDROCHLORIDE

Application Number

74450

Product Number

3

Dosage Form

-

Strength

250MG

Approval Date

1996-05-16

Regulatory Status

RX

2018
17 Apr
RX Application: 208342

Drug Name

MIGLUSTAT

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2018-04-17

208342 / 1

Active Ingredient

MIGLUSTAT

Application Number

208342

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2018-04-17

Regulatory Status

RX

2002
10 Jul
RX Application: 76095

Drug Name

MISOPROSTOL

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2002-07-10

76095 / 1

Active Ingredient

MISOPROSTOL

Application Number

76095

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2002-07-10

Regulatory Status

RX

2002
10 Jul
RX Application: 76095

Drug Name

MISOPROSTOL

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2002-07-10

76095 / 2

Active Ingredient

MISOPROSTOL

Application Number

76095

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2002-07-10

Regulatory Status

RX

2018
17 Apr
Discontinued Application: 205509

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

2018-04-17

205509 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

205509

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

2018-04-17

Regulatory Status

Discontinued

2018
17 Apr
Discontinued Application: 205509

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

20MG/5ML

Approval Date

2018-04-17

205509 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

205509

Product Number

2

Dosage Form

-

Strength

20MG/5ML

Approval Date

2018-04-17

Regulatory Status

Discontinued

2018
17 Apr
Discontinued Application: 205509

Drug Name

MORPHINE SULFATE

Product Number

3

Dosage Form

-

Strength

100MG/5ML

Approval Date

2018-04-17

205509 / 3

Active Ingredient

MORPHINE SULFATE

Application Number

205509

Product Number

3

Dosage Form

-

Strength

100MG/5ML

Approval Date

2018-04-17

Regulatory Status

Discontinued

2010
07 Jul
Discontinued Application: 78751

Drug Name

NARATRIPTAN

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2010-07-07

78751 / 1

Active Ingredient

NARATRIPTAN HYDROCHLORIDE

Application Number

78751

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2010-07-07

Regulatory Status

Discontinued

2010
07 Jul
Discontinued Application: 78751

Drug Name

NARATRIPTAN

Product Number

2

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2010-07-07

78751 / 2

Active Ingredient

NARATRIPTAN HYDROCHLORIDE

Application Number

78751

Product Number

2

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2010-07-07

Regulatory Status

Discontinued

2015
16 Apr
RX Application: 203659

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2015-04-16

203659 / 1

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

203659

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2015-04-16

Regulatory Status

RX

2015
16 Apr
RX Application: 203659

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2015-04-16

203659 / 2

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

203659

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2015-04-16

Regulatory Status

RX

2015
16 Apr
RX Application: 203659

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2015-04-16

203659 / 3

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

203659

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2015-04-16

Regulatory Status

RX

2015
16 Apr
RX Application: 203659

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2015-04-16

203659 / 4

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

203659

Product Number

4

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2015-04-16

Regulatory Status

RX

2003
16 Sep
Discontinued Application: 76072

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-09-16

76072 / 1

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76072

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-09-16

Regulatory Status

Discontinued

2003
16 Sep
Discontinued Application: 76072

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2003-09-16

76072 / 2

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76072

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2003-09-16

Regulatory Status

Discontinued

2003
16 Sep
Discontinued Application: 76072

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2003-09-16

76072 / 3

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76072

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2003-09-16

Regulatory Status

Discontinued

2003
16 Sep
Discontinued Application: 76072

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2003-09-16

76072 / 4

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76072

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2003-09-16

Regulatory Status

Discontinued

2003
16 Sep
Discontinued Application: 76072

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

250MG

Approval Date

2003-09-16

76072 / 5

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76072

Product Number

5

Dosage Form

-

Strength

250MG

Approval Date

2003-09-16

Regulatory Status

Discontinued

1996
10 Dec
Discontinued Application: 74439

Drug Name

NICARDIPINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1996-12-10

74439 / 1

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

74439

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1996-12-10

Regulatory Status

Discontinued

1996
10 Dec
Discontinued Application: 74439

Drug Name

NICARDIPINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1996-12-10

74439 / 2

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

74439

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1996-12-10

Regulatory Status

Discontinued

1996
28 Oct
Discontinued Application: 74540

Drug Name

NICARDIPINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1996-10-28

74540 / 1

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

74540

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1996-10-28

Regulatory Status

Discontinued

1996
28 Oct
Discontinued Application: 74540

Drug Name

NICARDIPINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1996-10-28

74540 / 2

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

74540

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1996-10-28

Regulatory Status

Discontinued

1996
28 Oct
RX Application: 74670

Drug Name

NICARDIPINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1996-10-28

74670 / 1

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

74670

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1996-10-28

Regulatory Status

RX

1996
28 Oct
RX Application: 74670

Drug Name

NICARDIPINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1996-10-28

74670 / 2

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

74670

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1996-10-28

Regulatory Status

RX

2016
15 Jul
RX Application: 207631

Drug Name

NILUTAMIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2016-07-15

207631 / 1

Active Ingredient

NILUTAMIDE

Application Number

207631

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2016-07-15

Regulatory Status

RX

2025
03 Feb
RX Application: 214844

Drug Name

NITAZOXANIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2025-02-03

214844 / 1

Active Ingredient

NITAZOXANIDE

Application Number

214844

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2025-02-03

Regulatory Status

RX

2002
08 Jul
Discontinued Application: 75461

Drug Name

NIZATIDINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2002-07-08

75461 / 1

Active Ingredient

NIZATIDINE

Application Number

75461

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2002-07-08

Regulatory Status

Discontinued

2002
08 Jul
Discontinued Application: 75461

Drug Name

NIZATIDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2002-07-08

75461 / 2

Active Ingredient

NIZATIDINE

Application Number

75461

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2002-07-08

Regulatory Status

Discontinued

2002
12 Sep
Discontinued Application: 75668

Drug Name

NIZATIDINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2002-09-12

75668 / 1

Active Ingredient

NIZATIDINE

Application Number

75668

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2002-09-12

Regulatory Status

Discontinued

2002
12 Sep
Discontinued Application: 75668

Drug Name

NIZATIDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2002-09-12

75668 / 2

Active Ingredient

NIZATIDINE

Application Number

75668

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2002-09-12

Regulatory Status

Discontinued

1992
31 Dec
Discontinued Application: 74054

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1992-12-31

74054 / 1

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

74054

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1992-12-31

Regulatory Status

Discontinued

1992
31 Dec
Discontinued Application: 74054

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1992-12-31

74054 / 2

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

74054

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1992-12-31

Regulatory Status

Discontinued

1992
31 Dec
Discontinued Application: 74054

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1992-12-31

74054 / 3

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

74054

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1992-12-31

Regulatory Status

Discontinued

1992
31 Dec
Discontinued Application: 74054

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

1992-12-31

74054 / 4

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

74054

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

1992-12-31

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62222

Drug Name

OXACILLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

62222 / 1

Active Ingredient

OXACILLIN SODIUM

Application Number

62222

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62222

Drug Name

OXACILLIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

62222 / 2

Active Ingredient

OXACILLIN SODIUM

Application Number

62222

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

2007
11 Dec
RX Application: 78005

Drug Name

OXCARBAZEPINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2007-12-11

78005 / 1

Active Ingredient

OXCARBAZEPINE

Application Number

78005

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2007-12-11

Regulatory Status

RX

2007
11 Dec
RX Application: 78005

Drug Name

OXCARBAZEPINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2007-12-11

78005 / 2

Active Ingredient

OXCARBAZEPINE

Application Number

78005

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2007-12-11

Regulatory Status

RX

2007
11 Dec
RX Application: 78005

Drug Name

OXCARBAZEPINE

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2007-12-11

78005 / 3

Active Ingredient

OXCARBAZEPINE

Application Number

78005

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2007-12-11

Regulatory Status

RX

1992
30 Sep
Discontinued Application: 20209

Drug Name

OXISTAT

Product Number

1

Dosage Form

-

Strength

EQ 1% BASE

Approval Date

1992-09-30

20209 / 1

Active Ingredient

OXICONAZOLE NITRATE

Application Number

20209

Product Number

1

Dosage Form

-

Strength

EQ 1% BASE

Approval Date

1992-09-30

Regulatory Status

Discontinued

1998
27 Feb
Discontinued Application: 40255

Drug Name

OXYCODONE AND ASPIRIN

Product Number

1

Dosage Form

-

Strength

325MG;4.5MG;0.38MG

Approval Date

1998-02-27

40255 / 1

Active Ingredient

ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE

Application Number

40255

Product Number

1

Dosage Form

-

Strength

325MG;4.5MG;0.38MG

Approval Date

1998-02-27

Regulatory Status

Discontinued

2017
30 Aug
Discontinued Application: 203447

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2017-08-30

203447 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

203447

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2017-08-30

Regulatory Status

Discontinued

2015
01 Jun
RX Application: 204979

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2015-06-01

204979 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

204979

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2015-06-01

Regulatory Status

RX

2016
31 Mar
RX Application: 205177

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2016-03-31

205177 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

205177

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2016-03-31

Regulatory Status

RX

1997
28 Feb
Discontinued Application: 20453

Drug Name

PANDEL

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1997-02-28

20453 / 1

Active Ingredient

HYDROCORTISONE PROBUTATE

Application Number

20453

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1997-02-28

Regulatory Status

Discontinued

1997
09 Jul
RX Application: 74878

Drug Name

PENTOXIFYLLINE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1997-07-09

74878 / 1

Active Ingredient

PENTOXIFYLLINE

Application Number

74878

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1997-07-09

Regulatory Status

RX

1998
04 Sep
Discontinued Application: 75107

Drug Name

PENTOXIFYLLINE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1998-09-04

75107 / 1

Active Ingredient

PENTOXIFYLLINE

Application Number

75107

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1998-09-04

Regulatory Status

Discontinued

1999
03 Sep
Discontinued Application: 75199

Drug Name

PENTOXIFYLLINE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1999-09-03

75199 / 1

Active Ingredient

PENTOXIFYLLINE

Application Number

75199

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1999-09-03

Regulatory Status

Discontinued

2009
10 Nov
Discontinued Application: 78138

Drug Name

PERINDOPRIL ERBUMINE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2009-11-10

78138 / 1

Active Ingredient

PERINDOPRIL ERBUMINE

Application Number

78138

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2009-11-10

Regulatory Status

Discontinued

2009
10 Nov
Discontinued Application: 78138

Drug Name

PERINDOPRIL ERBUMINE

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2009-11-10

78138 / 2

Active Ingredient

PERINDOPRIL ERBUMINE

Application Number

78138

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2009-11-10

Regulatory Status

Discontinued

2009
10 Nov
Discontinued Application: 78138

Drug Name

PERINDOPRIL ERBUMINE

Product Number

3

Dosage Form

-

Strength

8MG

Approval Date

2009-11-10

78138 / 3

Active Ingredient

PERINDOPRIL ERBUMINE

Application Number

78138

Product Number

3

Dosage Form

-

Strength

8MG

Approval Date

2009-11-10

Regulatory Status

Discontinued

1987
10 Sep
Discontinued Application: 89456

Drug Name

PERPHENAZINE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1987-09-10

89456 / 1

Active Ingredient

PERPHENAZINE

Application Number

89456

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1987-09-10

Regulatory Status

Discontinued

1987
10 Sep
Discontinued Application: 89457

Drug Name

PERPHENAZINE

Product Number

1

Dosage Form

-

Strength

16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-09-10

89457 / 1

Active Ingredient

PERPHENAZINE

Application Number

89457

Product Number

1

Dosage Form

-

Strength

16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-09-10

Regulatory Status

Discontinued

1987
10 Sep
Discontinued Application: 89707

Drug Name

PERPHENAZINE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1987-09-10

89707 / 1

Active Ingredient

PERPHENAZINE

Application Number

89707

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1987-09-10

Regulatory Status

Discontinued

1987
10 Sep
Discontinued Application: 89708

Drug Name

PERPHENAZINE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1987-09-10

89708 / 1

Active Ingredient

PERPHENAZINE

Application Number

89708

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1987-09-10

Regulatory Status

Discontinued

1984
02 Apr
Discontinued Application: 8604

Drug Name

PHENERGAN VC

Product Number

3

Dosage Form

-

Strength

5MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-04-02

8604 / 3

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

Application Number

8604

Product Number

3

Dosage Form

-

Strength

5MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-04-02

Regulatory Status

Discontinued

1984
02 Apr
Discontinued Application: 8306

Drug Name

PHENERGAN VC W/ CODEINE

Product Number

5

Dosage Form

-

Strength

10MG/5ML;5MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-04-02

8306 / 5

Active Ingredient

CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

Application Number

8306

Product Number

5

Dosage Form

-

Strength

10MG/5ML;5MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-04-02

Regulatory Status

Discontinued

1984
02 Apr
Discontinued Application: 8306

Drug Name

PHENERGAN W/ CODEINE

Product Number

4

Dosage Form

-

Strength

10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-04-02

8306 / 4

Active Ingredient

CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

Application Number

8306

Product Number

4

Dosage Form

-

Strength

10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-04-02

Regulatory Status

Discontinued

1993
29 Mar
RX Application: 73609

Drug Name

PINDOLOL

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1993-03-29

73609 / 1

Active Ingredient

PINDOLOL

Application Number

73609

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1993-03-29

Regulatory Status

RX

1993
29 Mar
RX Application: 73609

Drug Name

PINDOLOL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1993-03-29

73609 / 2

Active Ingredient

PINDOLOL

Application Number

73609

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1993-03-29

Regulatory Status

RX

2015
15 Dec
OTC Application: 202850

Drug Name

POLYETHYLENE GLYCOL 3350

Product Number

1

Dosage Form

-

Strength

17GM/SCOOPFUL

Approval Date

2015-12-15

202850 / 1

Active Ingredient

POLYETHYLENE GLYCOL 3350

Application Number

202850

Product Number

1

Dosage Form

-

Strength

17GM/SCOOPFUL

Approval Date

2015-12-15

Regulatory Status

OTC

2021
30 Nov
OTC Application: 202850

Drug Name

POLYETHYLENE GLYCOL 3350

Product Number

2

Dosage Form

-

Strength

17GM/PACKET

Approval Date

2021-11-30

202850 / 2

Active Ingredient

POLYETHYLENE GLYCOL 3350

Application Number

202850

Product Number

2

Dosage Form

-

Strength

17GM/PACKET

Approval Date

2021-11-30

Regulatory Status

OTC

2020
14 Jan
RX Application: 212779

Drug Name

POTASSIUM CITRATE

Product Number

1

Dosage Form

-

Strength

10MEQ

Approval Date

2020-01-14

212779 / 1

Active Ingredient

POTASSIUM CITRATE

Application Number

212779

Product Number

1

Dosage Form

-

Strength

10MEQ

Approval Date

2020-01-14

Regulatory Status

RX

2020
14 Jan
RX Application: 212779

Drug Name

POTASSIUM CITRATE

Product Number

2

Dosage Form

-

Strength

15MEQ

Approval Date

2020-01-14

212779 / 2

Active Ingredient

POTASSIUM CITRATE

Application Number

212779

Product Number

2

Dosage Form

-

Strength

15MEQ

Approval Date

2020-01-14

Regulatory Status

RX

1989
16 May
Discontinued Application: 72577

Drug Name

PRAZOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1989-05-16

72577 / 1

Active Ingredient

PRAZOSIN HYDROCHLORIDE

Application Number

72577

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1989-05-16

Regulatory Status

Discontinued

1989
16 May
Discontinued Application: 72577

Drug Name

PRAZOSIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

1989-05-16

72577 / 2

Active Ingredient

PRAZOSIN HYDROCHLORIDE

Application Number

72577

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

1989-05-16

Regulatory Status

Discontinued

1989
16 May
Discontinued Application: 72577

Drug Name

PRAZOSIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1989-05-16

72577 / 3

Active Ingredient

PRAZOSIN HYDROCHLORIDE

Application Number

72577

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1989-05-16

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83734

Drug Name

PROBENECID AND COLCHICINE

Product Number

1

Dosage Form

-

Strength

0.5MG;500MG

Approval Date

1982-01-01

83734 / 1

Active Ingredient

COLCHICINE; PROBENECID

Application Number

83734

Product Number

1

Dosage Form

-

Strength

0.5MG;500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996
13 Dec
Discontinued Application: 40111

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

1996-12-13

40111 / 1

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

40111

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

1996-12-13

Regulatory Status

Discontinued

1985
02 Dec
Discontinued Application: 88958

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1985-12-02

88958 / 1

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

88958

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1985-12-02

Regulatory Status

Discontinued

1985
02 Dec
Discontinued Application: 88959

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1985-12-02

88959 / 1

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

88959

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1985-12-02

Regulatory Status

Discontinued

1985
22 Jul
Discontinued Application: 88974

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1985-07-22

88974 / 1

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

88974

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1985-07-22

Regulatory Status

Discontinued

1986
01 Jul
Discontinued Application: 89219

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1986-07-01

89219 / 1

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

89219

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1986-07-01

Regulatory Status

Discontinued

1986
01 Jul
Discontinued Application: 89219

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

1986-07-01

89219 / 2

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

89219

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

1986-07-01

Regulatory Status

Discontinued

1986
01 Jul
Discontinued Application: 89219

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1986-07-01

89219 / 3

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

89219

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1986-07-01

Regulatory Status

Discontinued

1987
14 Aug
Discontinued Application: 89369

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1987-08-14

89369 / 1

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

89369

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1987-08-14

Regulatory Status

Discontinued

1987
09 Jan
Discontinued Application: 89369

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1987-01-09

89369 / 2

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

89369

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1987-01-09

Regulatory Status

Discontinued

1987
14 Aug
Discontinued Application: 89369

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

1987-08-14

89369 / 3

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

89369

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

1987-08-14

Regulatory Status

Discontinued

1987
23 Mar
Discontinued Application: 89438

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

1987-03-23

89438 / 1

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

89438

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

1987-03-23

Regulatory Status

Discontinued

1984
02 Apr
RX Application: 11265

Drug Name

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

15MG/5ML;6.25MG/5ML

Approval Date

1984-04-02

11265 / 2

Active Ingredient

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE

Application Number

11265

Product Number

2

Dosage Form

-

Strength

15MG/5ML;6.25MG/5ML

Approval Date

1984-04-02

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 8381

Drug Name

PROMETHAZINE HYDROCHLORIDE PLAIN

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

8381 / 3

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

8381

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
18 Apr
Discontinued Application: 8381

Drug Name

PROMETHAZINE HYDROCHLORIDE PLAIN

Product Number

4

Dosage Form

-

Strength

6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-04-18

8381 / 4

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

8381

Product Number

4

Dosage Form

-

Strength

6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-04-18

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80259

Drug Name

PROMPT PHENYTOIN SODIUM

Product Number

1

Dosage Form

-

Strength

100MG PROMPT

Approval Date

1982-01-01

80259 / 1

Active Ingredient

PHENYTOIN SODIUM

Application Number

80259

Product Number

1

Dosage Form

-

Strength

100MG PROMPT

Approval Date

1982-01-01

Regulatory Status

Discontinued

2004
23 Apr
RX Application: 76550

Drug Name

PROPAFENONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2004-04-23

76550 / 1

Active Ingredient

PROPAFENONE HYDROCHLORIDE

Application Number

76550

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2004-04-23

Regulatory Status

RX

2004
23 Apr
RX Application: 76550

Drug Name

PROPAFENONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

225MG

Approval Date

2004-04-23

76550 / 2

Active Ingredient

PROPAFENONE HYDROCHLORIDE

Application Number

76550

Product Number

2

Dosage Form

-

Strength

225MG

Approval Date

2004-04-23

Regulatory Status

RX

2004
23 Apr
RX Application: 76550

Drug Name

PROPAFENONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2004-04-23

76550 / 3

Active Ingredient

PROPAFENONE HYDROCHLORIDE

Application Number

76550

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2004-04-23

Regulatory Status

RX

1987
15 Jul
Discontinued Application: 71791

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

1987-07-15

71791 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

71791

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

1987-07-15

Regulatory Status

Discontinued

1988
06 Apr
Discontinued Application: 71977

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

1988-04-06

71977 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

71977

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

1988-04-06

Regulatory Status

Discontinued

1986
01 Oct
Discontinued Application: 70705

Drug Name

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG;80MG

Approval Date

1986-10-01

70705 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE

Application Number

70705

Product Number

1

Dosage Form

-

Strength

25MG;80MG

Approval Date

1986-10-01

Regulatory Status

Discontinued

1986
01 Oct
Discontinued Application: 70705

Drug Name

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

25MG;40MG

Approval Date

1986-10-01

70705 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE

Application Number

70705

Product Number

2

Dosage Form

-

Strength

25MG;40MG

Approval Date

1986-10-01

Regulatory Status

Discontinued

1988
14 Mar
Discontinued Application: 72043

Drug Name

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG;80MG

Approval Date

1988-03-14

72043 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE

Application Number

72043

Product Number

1

Dosage Form

-

Strength

25MG;80MG

Approval Date

1988-03-14

Regulatory Status

Discontinued

1988
14 Mar
Discontinued Application: 72043

Drug Name

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

25MG;40MG

Approval Date

1988-03-14

72043 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE

Application Number

72043

Product Number

2

Dosage Form

-

Strength

25MG;40MG

Approval Date

1988-03-14

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80215

Drug Name

PROPYLTHIOURACIL

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

80215 / 1

Active Ingredient

PROPYLTHIOURACIL

Application Number

80215

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8975

Drug Name

PURIFIED CORTROPHIN GEL

Product Number

1

Dosage Form

-

Strength

40 UNITS/ML

Approval Date

1982-01-01

8975 / 1

Active Ingredient

CORTICOTROPIN

Application Number

8975

Product Number

1

Dosage Form

-

Strength

40 UNITS/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 8975

Drug Name

PURIFIED CORTROPHIN GEL

Product Number

2

Dosage Form

-

Strength

80 UNITS/ML

Approval Date

1982-01-01

8975 / 2

Active Ingredient

CORTICOTROPIN

Application Number

8975

Product Number

2

Dosage Form

-

Strength

80 UNITS/ML

Approval Date

1982-01-01

Regulatory Status

RX

2003
08 Oct
RX Application: 40512

Drug Name

PYRIDOSTIGMINE BROMIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2003-10-08

40512 / 1

Active Ingredient

PYRIDOSTIGMINE BROMIDE

Application Number

40512

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2003-10-08

Regulatory Status

RX

2005
20 Jul
Discontinued Application: 40512

Drug Name

PYRIDOSTIGMINE BROMIDE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2005-07-20

40512 / 2

Active Ingredient

PYRIDOSTIGMINE BROMIDE

Application Number

40512

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2005-07-20

Regulatory Status

Discontinued

2007
24 Aug
Discontinued Application: 75504

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-08-24

75504 / 1

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

75504

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-08-24

Regulatory Status

Discontinued

2007
24 Aug
Discontinued Application: 75504

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-08-24

75504 / 2

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

75504

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-08-24

Regulatory Status

Discontinued

2007
24 Aug
Discontinued Application: 75504

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2007-08-24

75504 / 3

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

75504

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2007-08-24

Regulatory Status

Discontinued

2007
24 Aug
Discontinued Application: 75504

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2007-08-24

75504 / 4

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

75504

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2007-08-24

Regulatory Status

Discontinued

1982
29 Sep
Discontinued Application: 87810

Drug Name

QUINIDINE GLUCONATE

Product Number

1

Dosage Form

-

Strength

324MG

Approval Date

1982-09-29

87810 / 1

Active Ingredient

QUINIDINE GLUCONATE

Application Number

87810

Product Number

1

Dosage Form

-

Strength

324MG

Approval Date

1982-09-29

Regulatory Status

Discontinued

1997
31 Jul
Discontinued Application: 74488

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1997-07-31

74488 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

74488

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1997-07-31

Regulatory Status

Discontinued

1997
31 Jul
Discontinued Application: 74488

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

1997-07-31

74488 / 2

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

74488

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

1997-07-31

Regulatory Status

Discontinued

2000
14 Jan
Discontinued Application: 75212

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2000-01-14

75212 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

75212

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2000-01-14

Regulatory Status

Discontinued

2000
14 Jan
Discontinued Application: 75296

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2000-01-14

75296 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

75296

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2000-01-14

Regulatory Status

Discontinued

2005
19 Dec
Discontinued Application: 77426

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2005-12-19

77426 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

77426

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2005-12-19

Regulatory Status

Discontinued

2005
19 Dec
Discontinued Application: 77426

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2005-12-19

77426 / 2

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

77426

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2005-12-19

Regulatory Status

Discontinued

2019
29 Oct
Discontinued Application: 210482

Drug Name

RANOLAZINE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2019-10-29

210482 / 1

Active Ingredient

RANOLAZINE

Application Number

210482

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2019-10-29

Regulatory Status

Discontinued

2019
29 Oct
Discontinued Application: 210482

Drug Name

RANOLAZINE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2019-10-29

210482 / 2

Active Ingredient

RANOLAZINE

Application Number

210482

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2019-10-29

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 17854

Drug Name

REGLAN

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1982-01-01

17854 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

17854

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1982-01-01

Regulatory Status

RX

1987
05 May
RX Application: 17854

Drug Name

REGLAN

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1987-05-05

17854 / 2

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

17854

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1987-05-05

Regulatory Status

RX

2009
30 Jan
RX Application: 76440

Drug Name

RISPERIDONE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2009-01-30

76440 / 1

Active Ingredient

RISPERIDONE

Application Number

76440

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2009-01-30

Regulatory Status

RX

2013
25 Jan
Discontinued Application: 76747

Drug Name

ROSIGLITAZONE MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2013-01-25

76747 / 1

Active Ingredient

ROSIGLITAZONE MALEATE

Application Number

76747

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2013-01-25

Regulatory Status

Discontinued

2013
25 Jan
Discontinued Application: 76747

Drug Name

ROSIGLITAZONE MALEATE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2013-01-25

76747 / 2

Active Ingredient

ROSIGLITAZONE MALEATE

Application Number

76747

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2013-01-25

Regulatory Status

Discontinued

2013
25 Jan
Discontinued Application: 76747

Drug Name

ROSIGLITAZONE MALEATE

Product Number

3

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2013-01-25

76747 / 3

Active Ingredient

ROSIGLITAZONE MALEATE

Application Number

76747

Product Number

3

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2013-01-25

Regulatory Status

Discontinued

2011
13 May
Discontinued Application: 90590

Drug Name

SODIUM POLYSTYRENE SULFONATE

Product Number

1

Dosage Form

-

Strength

15GM/60ML

Approval Date

2011-05-13

90590 / 1

Active Ingredient

SODIUM POLYSTYRENE SULFONATE

Application Number

90590

Product Number

1

Dosage Form

-

Strength

15GM/60ML

Approval Date

2011-05-13

Regulatory Status

Discontinued

1987
02 Jun
Discontinued Application: 70028

Drug Name

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Product Number

1

Dosage Form

-

Strength

200MG/5ML;40MG/5ML

Approval Date

1987-06-02

70028 / 1

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

70028

Product Number

1

Dosage Form

-

Strength

200MG/5ML;40MG/5ML

Approval Date

1987-06-02

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80142

Drug Name

SULFISOXAZOLE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

80142 / 1

Active Ingredient

SULFISOXAZOLE

Application Number

80142

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1992
28 Feb
Discontinued Application: 72973

Drug Name

SULINDAC

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1992-02-28

72973 / 1

Active Ingredient

SULINDAC

Application Number

72973

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1992-02-28

Regulatory Status

Discontinued

1992
28 Feb
Discontinued Application: 72973

Drug Name

SULINDAC

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

1992-02-28

72973 / 2

Active Ingredient

SULINDAC

Application Number

72973

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

1992-02-28

Regulatory Status

Discontinued

2016
13 Jul
Discontinued Application: 203490

Drug Name

TEMOZOLOMIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2016-07-13

203490 / 1

Active Ingredient

TEMOZOLOMIDE

Application Number

203490

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2016-07-13

Regulatory Status

Discontinued

2016
13 Jul
Discontinued Application: 203490

Drug Name

TEMOZOLOMIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2016-07-13

203490 / 2

Active Ingredient

TEMOZOLOMIDE

Application Number

203490

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2016-07-13

Regulatory Status

Discontinued

2016
13 Jul
Discontinued Application: 203490

Drug Name

TEMOZOLOMIDE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2016-07-13

203490 / 3

Active Ingredient

TEMOZOLOMIDE

Application Number

203490

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2016-07-13

Regulatory Status

Discontinued

2016
13 Jul
Discontinued Application: 203490

Drug Name

TEMOZOLOMIDE

Product Number

4

Dosage Form

-

Strength

140MG

Approval Date

2016-07-13

203490 / 4

Active Ingredient

TEMOZOLOMIDE

Application Number

203490

Product Number

4

Dosage Form

-

Strength

140MG

Approval Date

2016-07-13

Regulatory Status

Discontinued

2016
13 Jul
Discontinued Application: 203490

Drug Name

TEMOZOLOMIDE

Product Number

5

Dosage Form

-

Strength

180MG

Approval Date

2016-07-13

203490 / 5

Active Ingredient

TEMOZOLOMIDE

Application Number

203490

Product Number

5

Dosage Form

-

Strength

180MG

Approval Date

2016-07-13

Regulatory Status

Discontinued

2016
13 Jul
Discontinued Application: 203490

Drug Name

TEMOZOLOMIDE

Product Number

6

Dosage Form

-

Strength

250MG

Approval Date

2016-07-13

203490 / 6

Active Ingredient

TEMOZOLOMIDE

Application Number

203490

Product Number

6

Dosage Form

-

Strength

250MG

Approval Date

2016-07-13

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12546

Drug Name

TENUATE DOSPAN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

12546 / 1

Active Ingredient

DIETHYLPROPION HYDROCHLORIDE

Application Number

12546

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

2012
14 Feb
Discontinued Application: 202763

Drug Name

TESTOSTERONE

Product Number

1

Dosage Form

-

Strength

25MG/2.5GM PACKET

Approval Date

2012-02-14

202763 / 1

Active Ingredient

TESTOSTERONE

Application Number

202763

Product Number

1

Dosage Form

-

Strength

25MG/2.5GM PACKET

Approval Date

2012-02-14

Regulatory Status

Discontinued

2012
14 Feb
Discontinued Application: 202763

Drug Name

TESTOSTERONE

Product Number

2

Dosage Form

-

Strength

50MG/5GM PACKET

Approval Date

2012-02-14

202763 / 2

Active Ingredient

TESTOSTERONE

Application Number

202763

Product Number

2

Dosage Form

-

Strength

50MG/5GM PACKET

Approval Date

2012-02-14

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61471

Drug Name

TETRACYCLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

61471 / 1

Active Ingredient

TETRACYCLINE HYDROCHLORIDE

Application Number

61471

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1983
14 Apr
Discontinued Application: 88194

Drug Name

THIORIDAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1983-04-14

88194 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

88194

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1983-04-14

Regulatory Status

Discontinued

1983
14 Apr
Discontinued Application: 88270

Drug Name

THIORIDAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1983-04-14

88270 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

88270

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1983-04-14

Regulatory Status

Discontinued

1983
14 Apr
Discontinued Application: 88271

Drug Name

THIORIDAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1983-04-14

88271 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

88271

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1983-04-14

Regulatory Status

Discontinued

1983
14 Apr
Discontinued Application: 88272

Drug Name

THIORIDAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1983-04-14

88272 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

88272

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1983-04-14

Regulatory Status

Discontinued

1983
03 Oct
Discontinued Application: 88273

Drug Name

THIORIDAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1983-10-03

88273 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

88273

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1983-10-03

Regulatory Status

Discontinued

1985
17 May
Discontinued Application: 88456

Drug Name

THIORIDAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1985-05-17

88456 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

88456

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1985-05-17

Regulatory Status

Discontinued

1985
17 May
Discontinued Application: 88493

Drug Name

THIORIDAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1985-05-17

88493 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

88493

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1985-05-17

Regulatory Status

Discontinued

1987
09 Nov
Discontinued Application: 89602

Drug Name

THIORIDAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

1987-11-09

89602 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

89602

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

1987-11-09

Regulatory Status

Discontinued

1987
09 Nov
Discontinued Application: 89603

Drug Name

THIORIDAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1987-11-09

89603 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

89603

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1987-11-09

Regulatory Status

Discontinued

1991
31 Jul
Discontinued Application: 72917

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1991-07-31

72917 / 1

Active Ingredient

TIMOLOL MALEATE

Application Number

72917

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1991-07-31

Regulatory Status

Discontinued

1991
31 Jul
Discontinued Application: 72918

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1991-07-31

72918 / 1

Active Ingredient

TIMOLOL MALEATE

Application Number

72918

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1991-07-31

Regulatory Status

Discontinued

1991
31 Jul
Discontinued Application: 72919

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1991-07-31

72919 / 1

Active Ingredient

TIMOLOL MALEATE

Application Number

72919

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1991-07-31

Regulatory Status

Discontinued

2002
12 Jul
Discontinued Application: 76283

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2002-07-12

76283 / 1

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

76283

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2002-07-12

Regulatory Status

Discontinued

2002
12 Jul
Discontinued Application: 76283

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2002-07-12

76283 / 2

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

76283

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2002-07-12

Regulatory Status

Discontinued

2002
03 Jul
Discontinued Application: 76284

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2002-07-03

76284 / 1

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

76284

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2002-07-03

Regulatory Status

Discontinued

2002
03 Jul
Discontinued Application: 76284

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2002-07-03

76284 / 2

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

76284

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2002-07-03

Regulatory Status

Discontinued

2004
30 Sep
Discontinued Application: 76321

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2004-09-30

76321 / 1

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

76321

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2004-09-30

Regulatory Status

Discontinued

2004
30 Sep
Discontinued Application: 76321

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2004-09-30

76321 / 2

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

76321

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2004-09-30

Regulatory Status

Discontinued

2003
09 Apr
Discontinued Application: 76371

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2003-04-09

76371 / 1

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

76371

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2003-04-09

Regulatory Status

Discontinued

2003
09 Apr
Discontinued Application: 76371

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2003-04-09

76371 / 2

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

76371

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2003-04-09

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87093

Drug Name

TOLBUTAMIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

87093 / 1

Active Ingredient

TOLBUTAMIDE

Application Number

87093

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1992
24 Jan
Discontinued Application: 73308

Drug Name

TOLMETIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

1992-01-24

73308 / 1

Active Ingredient

TOLMETIN SODIUM

Application Number

73308

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

1992-01-24

Regulatory Status

Discontinued

1992
24 Jan
Discontinued Application: 73392

Drug Name

TOLMETIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

1992-01-24

73392 / 1

Active Ingredient

TOLMETIN SODIUM

Application Number

73392

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

1992-01-24

Regulatory Status

Discontinued

1992
29 May
Discontinued Application: 73519

Drug Name

TOLMETIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

1992-05-29

73519 / 1

Active Ingredient

TOLMETIN SODIUM

Application Number

73519

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

1992-05-29

Regulatory Status

Discontinued

1992
30 Jun
Discontinued Application: 73527

Drug Name

TOLMETIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE

Approval Date

1992-06-30

73527 / 1

Active Ingredient

TOLMETIN SODIUM

Application Number

73527

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE

Approval Date

1992-06-30

Regulatory Status

Discontinued

2016
25 Jul
RX Application: 203256

Drug Name

TRANEXAMIC ACID

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

2016-07-25

203256 / 1

Active Ingredient

TRANEXAMIC ACID

Application Number

203256

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

2016-07-25

Regulatory Status

RX

1996
31 Jan
Discontinued Application: 73467

Drug Name

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

50MG;75MG

Approval Date

1996-01-31

73467 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; TRIAMTERENE

Application Number

73467

Product Number

1

Dosage Form

-

Strength

50MG;75MG

Approval Date

1996-01-31

Regulatory Status

Discontinued

1995
30 Mar
Discontinued Application: 74259

Drug Name

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG;50MG

Approval Date

1995-03-30

74259 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; TRIAMTERENE

Application Number

74259

Product Number

1

Dosage Form

-

Strength

25MG;50MG

Approval Date

1995-03-30

Regulatory Status

Discontinued

1998
06 Jan
Discontinued Application: 74970

Drug Name

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG;37.5MG

Approval Date

1998-01-06

74970 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; TRIAMTERENE

Application Number

74970

Product Number

1

Dosage Form

-

Strength

25MG;37.5MG

Approval Date

1998-01-06

Regulatory Status

Discontinued

1992
25 Aug
RX Application: 73178

Drug Name

VALPROIC ACID

Product Number

1

Dosage Form

-

Strength

250MG/5ML

Approval Date

1992-08-25

73178 / 1

Active Ingredient

VALPROIC ACID

Application Number

73178

Product Number

1

Dosage Form

-

Strength

250MG/5ML

Approval Date

1992-08-25

Regulatory Status

RX

1986
15 Apr
RX Application: 50606

Drug Name

VANCOCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE

Approval Date

1986-04-15

50606 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

50606

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE

Approval Date

1986-04-15

Regulatory Status

RX

1986
15 Apr
RX Application: 50606

Drug Name

VANCOCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1986-04-15

50606 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

50606

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1986-04-15

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 61667

Drug Name

VANCOCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/6ML

Approval Date

1982-01-01

61667 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

61667

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/6ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1983
13 Jul
RX Application: 61667

Drug Name

VANCOCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1983-07-13

61667 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

61667

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1983-07-13

Regulatory Status

RX

2006
31 Oct
RX Application: 21902

Drug Name

VEREGEN

Product Number

1

Dosage Form

-

Strength

15%

Approval Date

2006-10-31

21902 / 1

Active Ingredient

SINECATECHINS

Application Number

21902

Product Number

1

Dosage Form

-

Strength

15%

Approval Date

2006-10-31

Regulatory Status

RX

2014
04 Mar
Discontinued Application: 90861

Drug Name

ZOLMITRIPTAN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2014-03-04

90861 / 1

Active Ingredient

ZOLMITRIPTAN

Application Number

90861

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2014-03-04

Regulatory Status

Discontinued

2014
04 Mar
Discontinued Application: 90861

Drug Name

ZOLMITRIPTAN

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2014-03-04

90861 / 2

Active Ingredient

ZOLMITRIPTAN

Application Number

90861

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2014-03-04

Regulatory Status

Discontinued

2005
22 Dec
Discontinued Application: 77639

Drug Name

ZONISAMIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2005-12-22

77639 / 1

Active Ingredient

ZONISAMIDE

Application Number

77639

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2005-12-22

Regulatory Status

Discontinued

2005
22 Dec
Discontinued Application: 77639

Drug Name

ZONISAMIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2005-12-22

77639 / 2

Active Ingredient

ZONISAMIDE

Application Number

77639

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2005-12-22

Regulatory Status

Discontinued

2005
22 Dec
Discontinued Application: 77639

Drug Name

ZONISAMIDE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2005-12-22

77639 / 3

Active Ingredient

ZONISAMIDE

Application Number

77639

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2005-12-22

Regulatory Status

Discontinued

2005
22 Dec
Discontinued Application: 77641

Drug Name

ZONISAMIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2005-12-22

77641 / 1

Active Ingredient

ZONISAMIDE

Application Number

77641

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2005-12-22

Regulatory Status

Discontinued

2005
22 Dec
Discontinued Application: 77641

Drug Name

ZONISAMIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2005-12-22

77641 / 2

Active Ingredient

ZONISAMIDE

Application Number

77641

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2005-12-22

Regulatory Status

Discontinued

2005
22 Dec
Discontinued Application: 77641

Drug Name

ZONISAMIDE

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2005-12-22

77641 / 3

Active Ingredient

ZONISAMIDE

Application Number

77641

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2005-12-22

Regulatory Status

Discontinued

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  • FDA Approved Drugs Database
    450 View
Drug Status Breakdown
450 total
  • RX
  • Discontinued
  • Unclassified
  • OTC
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

ACEBUTOLOL HYDROCHLORIDE

Application Number

74007

Product Number

1

Active Ingredient

ACEBUTOLOL HYDROCHLORIDE

Dosage Form

-

Strength

EQ 200MG BASE

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

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