Upsher-Smith Laboratories
FDA Approved Drugs

Upsher-Smith Laboratories

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
  • Total Records 162
  • Latest Approval Date Jan 22, 2026
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
162
View
Discontinued
75
View
RX
87
View
Company Overview

Company

Upsher-Smith Laboratories

Country

U.S.A

Website

Visit Website

Email

uslinfo@upsher-smith.com

Social Profiles

Company Snapshot

Upsher-Smith Laboratories

Upsher-Smith Laboratories, Inc., 6701 Evenstad Drive, Maple Grove, MN 55369

U.S.A

www.upsher-smith.com/ uslinfo@upsher-smith.com View on Map
FDA Approved Drug Records ( 162 records )
1986
05 Aug
RX Application: 70589

Drug Name

AMANTADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1986-08-05

70589 / 1

Active Ingredient

AMANTADINE HYDROCHLORIDE

Application Number

70589

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1986-08-05

Regulatory Status

RX

2002
16 Dec
RX Application: 76186

Drug Name

AMANTADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2002-12-16

76186 / 1

Active Ingredient

AMANTADINE HYDROCHLORIDE

Application Number

76186

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2002-12-16

Regulatory Status

RX

1998
23 Dec
Discontinued Application: 75315

Drug Name

AMIODARONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1998-12-23

75315 / 1

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

75315

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1998-12-23

Regulatory Status

Discontinued

2000
30 Jun
Discontinued Application: 75315

Drug Name

AMIODARONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2000-06-30

75315 / 2

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

75315

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2000-06-30

Regulatory Status

Discontinued

2005
01 Jun
RX Application: 40633

Drug Name

BETHANECHOL CHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2005-06-01

40633 / 1

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

40633

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2005-06-01

Regulatory Status

RX

2005
01 Jun
RX Application: 40634

Drug Name

BETHANECHOL CHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2005-06-01

40634 / 1

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

40634

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2005-06-01

Regulatory Status

RX

2005
01 Jun
RX Application: 40635

Drug Name

BETHANECHOL CHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2005-06-01

40635 / 1

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

40635

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2005-06-01

Regulatory Status

RX

2005
01 Jun
RX Application: 40636

Drug Name

BETHANECHOL CHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2005-06-01

40636 / 1

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

40636

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2005-06-01

Regulatory Status

RX

2018
25 Jul
RX Application: 209886

Drug Name

BEXAROTENE

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2018-07-25

209886 / 1

Active Ingredient

BEXAROTENE

Application Number

209886

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2018-07-25

Regulatory Status

RX

2024
12 Jun
Discontinued Application: 216772

Drug Name

BRIMONIDINE TARTRATE

Product Number

1

Dosage Form

-

Strength

0.15%

Approval Date

2024-06-12

216772 / 1

Active Ingredient

BRIMONIDINE TARTRATE

Application Number

216772

Product Number

1

Dosage Form

-

Strength

0.15%

Approval Date

2024-06-12

Regulatory Status

Discontinued

2025
30 Jul
Discontinued Application: 217599

Drug Name

BRIMONIDINE TARTRATE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2025-07-30

217599 / 1

Active Ingredient

BRIMONIDINE TARTRATE

Application Number

217599

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2025-07-30

Regulatory Status

Discontinued

2022
12 Dec
RX Application: 215598

Drug Name

BRIMONIDINE TARTRATE AND TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

0.2%;EQ 0.5% BASE

Approval Date

2022-12-12

215598 / 1

Active Ingredient

BRIMONIDINE TARTRATE; TIMOLOL MALEATE

Application Number

215598

Product Number

1

Dosage Form

-

Strength

0.2%;EQ 0.5% BASE

Approval Date

2022-12-12

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 83215

Drug Name

BROMPHENIRAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

83215 / 1

Active Ingredient

BROMPHENIRAMINE MALEATE

Application Number

83215

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2018
23 Jan
RX Application: 209916

Drug Name

BUMETANIDE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2018-01-23

209916 / 1

Active Ingredient

BUMETANIDE

Application Number

209916

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2018-01-23

Regulatory Status

RX

2018
23 Jan
RX Application: 209916

Drug Name

BUMETANIDE

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2018-01-23

209916 / 2

Active Ingredient

BUMETANIDE

Application Number

209916

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2018-01-23

Regulatory Status

RX

2018
23 Jan
RX Application: 209916

Drug Name

BUMETANIDE

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2018-01-23

209916 / 3

Active Ingredient

BUMETANIDE

Application Number

209916

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2018-01-23

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 84823

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

84823 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

84823

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84919

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

84919 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

84919

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84920

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

84920 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

84920

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 83386

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

83386 / 1

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

83386

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 84112

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

84112 / 1

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

84112

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 84113

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

84113 / 1

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

84113

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 84114

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

84114 / 1

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

84114

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 84115

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

84115 / 1

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

84115

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

RX

1996
24 Jan
Discontinued Application: 74506

Drug Name

CIMETIDINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1996-01-24

74506 / 1

Active Ingredient

CIMETIDINE

Application Number

74506

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1996-01-24

Regulatory Status

Discontinued

1996
24 Jan
Discontinued Application: 74506

Drug Name

CIMETIDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1996-01-24

74506 / 2

Active Ingredient

CIMETIDINE

Application Number

74506

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1996-01-24

Regulatory Status

Discontinued

1996
24 Jan
Discontinued Application: 74506

Drug Name

CIMETIDINE

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1996-01-24

74506 / 3

Active Ingredient

CIMETIDINE

Application Number

74506

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1996-01-24

Regulatory Status

Discontinued

1996
24 Jan
Discontinued Application: 74506

Drug Name

CIMETIDINE

Product Number

4

Dosage Form

-

Strength

800MG

Approval Date

1996-01-24

74506 / 4

Active Ingredient

CIMETIDINE

Application Number

74506

Product Number

4

Dosage Form

-

Strength

800MG

Approval Date

1996-01-24

Regulatory Status

Discontinued

2026
06 Jan
RX Application: 216487

Drug Name

CIPROFLOXACIN AND DEXAMETHASONE

Product Number

1

Dosage Form

-

Strength

0.3%;0.1%

Approval Date

2026-01-06

216487 / 1

Active Ingredient

CIPROFLOXACIN; DEXAMETHASONE

Application Number

216487

Product Number

1

Dosage Form

-

Strength

0.3%;0.1%

Approval Date

2026-01-06

Regulatory Status

RX

2018
22 Oct
RX Application: 209687

Drug Name

CLOBAZAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-10-22

209687 / 1

Active Ingredient

CLOBAZAM

Application Number

209687

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-10-22

Regulatory Status

RX

2018
22 Oct
RX Application: 209687

Drug Name

CLOBAZAM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-10-22

209687 / 2

Active Ingredient

CLOBAZAM

Application Number

209687

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-10-22

Regulatory Status

RX

2018
22 Oct
Discontinued Application: 210569

Drug Name

CLOBAZAM

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2018-10-22

210569 / 1

Active Ingredient

CLOBAZAM

Application Number

210569

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2018-10-22

Regulatory Status

Discontinued

2024
05 Nov
RX Application: 216720

Drug Name

DEFLAZACORT

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

2024-11-05

216720 / 1

Active Ingredient

DEFLAZACORT

Application Number

216720

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

2024-11-05

Regulatory Status

RX

2024
05 Nov
RX Application: 216720

Drug Name

DEFLAZACORT

Product Number

2

Dosage Form

-

Strength

18MG

Approval Date

2024-11-05

216720 / 2

Active Ingredient

DEFLAZACORT

Application Number

216720

Product Number

2

Dosage Form

-

Strength

18MG

Approval Date

2024-11-05

Regulatory Status

RX

2024
05 Nov
RX Application: 216720

Drug Name

DEFLAZACORT

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2024-11-05

216720 / 3

Active Ingredient

DEFLAZACORT

Application Number

216720

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2024-11-05

Regulatory Status

RX

2024
05 Nov
RX Application: 216720

Drug Name

DEFLAZACORT

Product Number

4

Dosage Form

-

Strength

36MG

Approval Date

2024-11-05

216720 / 4

Active Ingredient

DEFLAZACORT

Application Number

216720

Product Number

4

Dosage Form

-

Strength

36MG

Approval Date

2024-11-05

Regulatory Status

RX

2025
11 Aug
RX Application: 216992

Drug Name

DEFLAZACORT

Product Number

1

Dosage Form

-

Strength

22.75MG/ML

Approval Date

2025-08-11

216992 / 1

Active Ingredient

DEFLAZACORT

Application Number

216992

Product Number

1

Dosage Form

-

Strength

22.75MG/ML

Approval Date

2025-08-11

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 87533

Drug Name

DEXAMETHASONE

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

1982-01-01

87533 / 1

Active Ingredient

DEXAMETHASONE

Application Number

87533

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87534

Drug Name

DEXAMETHASONE

Product Number

1

Dosage Form

-

Strength

0.75MG

Approval Date

1982-01-01

87534 / 1

Active Ingredient

DEXAMETHASONE

Application Number

87534

Product Number

1

Dosage Form

-

Strength

0.75MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2025
11 Feb
RX Application: 218191

Drug Name

DIFLUPREDNATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2025-02-11

218191 / 1

Active Ingredient

DIFLUPREDNATE

Application Number

218191

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2025-02-11

Regulatory Status

RX

2008
29 Jul
RX Application: 78182

Drug Name

DIVALPROEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2008-07-29

78182 / 1

Active Ingredient

DIVALPROEX SODIUM

Application Number

78182

Product Number

1

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2008-07-29

Regulatory Status

RX

2008
29 Jul
RX Application: 78182

Drug Name

DIVALPROEX SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2008-07-29

78182 / 2

Active Ingredient

DIVALPROEX SODIUM

Application Number

78182

Product Number

2

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2008-07-29

Regulatory Status

RX

2008
29 Jul
RX Application: 78182

Drug Name

DIVALPROEX SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2008-07-29

78182 / 3

Active Ingredient

DIVALPROEX SODIUM

Application Number

78182

Product Number

3

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2008-07-29

Regulatory Status

RX

2021
18 Feb
Discontinued Application: 213661

Drug Name

DROXIDOPA

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2021-02-18

213661 / 1

Active Ingredient

DROXIDOPA

Application Number

213661

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2021-02-18

Regulatory Status

Discontinued

2021
18 Feb
Discontinued Application: 213661

Drug Name

DROXIDOPA

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2021-02-18

213661 / 2

Active Ingredient

DROXIDOPA

Application Number

213661

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2021-02-18

Regulatory Status

Discontinued

2021
18 Feb
Discontinued Application: 213661

Drug Name

DROXIDOPA

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2021-02-18

213661 / 3

Active Ingredient

DROXIDOPA

Application Number

213661

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2021-02-18

Regulatory Status

Discontinued

2023
02 May
RX Application: 212420

Drug Name

ELIGLUSTAT TARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 84MG BASE

Approval Date

2023-05-02

212420 / 1

Active Ingredient

ELIGLUSTAT TARTRATE

Application Number

212420

Product Number

1

Dosage Form

-

Strength

EQ 84MG BASE

Approval Date

2023-05-02

Regulatory Status

RX

2020
19 Feb
RX Application: 212417

Drug Name

ETHACRYNIC ACID

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2020-02-19

212417 / 1

Active Ingredient

ETHACRYNIC ACID

Application Number

212417

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2020-02-19

Regulatory Status

RX

2017
26 Jul
RX Application: 209208

Drug Name

EXEMESTANE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2017-07-26

209208 / 1

Active Ingredient

EXEMESTANE

Application Number

209208

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2017-07-26

Regulatory Status

RX

2022
15 Nov
RX Application: 216953

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/5ML

Approval Date

2022-11-15

216953 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

216953

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/5ML

Approval Date

2022-11-15

Regulatory Status

RX

1983
21 Oct
Discontinued Application: 88342

Drug Name

FLUOXYMESTERONE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1983-10-21

88342 / 1

Active Ingredient

FLUOXYMESTERONE

Application Number

88342

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1983-10-21

Regulatory Status

Discontinued

2022
24 Oct
RX Application: 213784

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2022-10-24

213784 / 1

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

213784

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2022-10-24

Regulatory Status

RX

2022
24 Oct
RX Application: 213784

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2022-10-24

213784 / 2

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

213784

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2022-10-24

Regulatory Status

RX

2022
24 Oct
RX Application: 213784

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2022-10-24

213784 / 3

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

213784

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2022-10-24

Regulatory Status

RX

2022
24 Oct
RX Application: 213784

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2022-10-24

213784 / 4

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

213784

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2022-10-24

Regulatory Status

RX

2001
05 Jan
Discontinued Application: 75887

Drug Name

FLUVOXAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2001-01-05

75887 / 1

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

75887

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2001-01-05

Regulatory Status

Discontinued

2001
05 Jan
Discontinued Application: 75887

Drug Name

FLUVOXAMINE MALEATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2001-01-05

75887 / 2

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

75887

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2001-01-05

Regulatory Status

Discontinued

2001
05 Jan
Discontinued Application: 75887

Drug Name

FLUVOXAMINE MALEATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2001-01-05

75887 / 3

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

75887

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2001-01-05

Regulatory Status

Discontinued

2005
12 Aug
Discontinued Application: 21406

Drug Name

FORTICAL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2005-08-12

21406 / 1

Active Ingredient

CALCITONIN SALMON RECOMBINANT

Application Number

21406

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2005-08-12

Regulatory Status

Discontinued

2004
08 Oct
Discontinued Application: 76188

Drug Name

FOSINOPRIL SODIUM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2004-10-08

76188 / 1

Active Ingredient

FOSINOPRIL SODIUM

Application Number

76188

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2004-10-08

Regulatory Status

Discontinued

2004
08 Oct
Discontinued Application: 76188

Drug Name

FOSINOPRIL SODIUM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2004-10-08

76188 / 2

Active Ingredient

FOSINOPRIL SODIUM

Application Number

76188

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2004-10-08

Regulatory Status

Discontinued

2004
08 Oct
Discontinued Application: 76188

Drug Name

FOSINOPRIL SODIUM

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2004-10-08

76188 / 3

Active Ingredient

FOSINOPRIL SODIUM

Application Number

76188

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2004-10-08

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83234

Drug Name

GLUTETHIMIDE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

83234 / 2

Active Ingredient

GLUTETHIMIDE

Application Number

83234

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83241

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

83241 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

83241

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83560

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

83560 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

83560

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83561

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

83561 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

83561

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85088

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

85088 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

85088

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2017
24 Mar
Discontinued Application: 206484

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

2017-03-24

206484 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

206484

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

2017-03-24

Regulatory Status

Discontinued

2017
24 Mar
Discontinued Application: 206484

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2017-03-24

206484 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

206484

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2017-03-24

Regulatory Status

Discontinued

2017
24 Mar
Discontinued Application: 206484

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

2017-03-24

206484 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

206484

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

2017-03-24

Regulatory Status

Discontinued

2021
21 Sep
RX Application: 212333

Drug Name

ISOTRETINOIN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-09-21

212333 / 1

Active Ingredient

ISOTRETINOIN

Application Number

212333

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-09-21

Regulatory Status

RX

2021
21 Sep
RX Application: 212333

Drug Name

ISOTRETINOIN

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2021-09-21

212333 / 2

Active Ingredient

ISOTRETINOIN

Application Number

212333

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2021-09-21

Regulatory Status

RX

2021
21 Sep
RX Application: 212333

Drug Name

ISOTRETINOIN

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2021-09-21

212333 / 3

Active Ingredient

ISOTRETINOIN

Application Number

212333

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2021-09-21

Regulatory Status

RX

2021
12 Apr
RX Application: 213571

Drug Name

ISOTRETINOIN

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2021-04-12

213571 / 1

Active Ingredient

ISOTRETINOIN

Application Number

213571

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2021-04-12

Regulatory Status

RX

2003
02 Oct
RX Application: 40416

Drug Name

JANTOVEN

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2003-10-02

40416 / 1

Active Ingredient

WARFARIN SODIUM

Application Number

40416

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2003-10-02

Regulatory Status

RX

2003
02 Oct
RX Application: 40416

Drug Name

JANTOVEN

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2003-10-02

40416 / 2

Active Ingredient

WARFARIN SODIUM

Application Number

40416

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2003-10-02

Regulatory Status

RX

2003
02 Oct
RX Application: 40416

Drug Name

JANTOVEN

Product Number

3

Dosage Form

-

Strength

2.5MG

Approval Date

2003-10-02

40416 / 3

Active Ingredient

WARFARIN SODIUM

Application Number

40416

Product Number

3

Dosage Form

-

Strength

2.5MG

Approval Date

2003-10-02

Regulatory Status

RX

2003
02 Oct
RX Application: 40416

Drug Name

JANTOVEN

Product Number

4

Dosage Form

-

Strength

3MG

Approval Date

2003-10-02

40416 / 4

Active Ingredient

WARFARIN SODIUM

Application Number

40416

Product Number

4

Dosage Form

-

Strength

3MG

Approval Date

2003-10-02

Regulatory Status

RX

2003
02 Oct
RX Application: 40416

Drug Name

JANTOVEN

Product Number

5

Dosage Form

-

Strength

4MG

Approval Date

2003-10-02

40416 / 5

Active Ingredient

WARFARIN SODIUM

Application Number

40416

Product Number

5

Dosage Form

-

Strength

4MG

Approval Date

2003-10-02

Regulatory Status

RX

2003
02 Oct
RX Application: 40416

Drug Name

JANTOVEN

Product Number

6

Dosage Form

-

Strength

5MG

Approval Date

2003-10-02

40416 / 6

Active Ingredient

WARFARIN SODIUM

Application Number

40416

Product Number

6

Dosage Form

-

Strength

5MG

Approval Date

2003-10-02

Regulatory Status

RX

2003
02 Oct
RX Application: 40416

Drug Name

JANTOVEN

Product Number

7

Dosage Form

-

Strength

6MG

Approval Date

2003-10-02

40416 / 7

Active Ingredient

WARFARIN SODIUM

Application Number

40416

Product Number

7

Dosage Form

-

Strength

6MG

Approval Date

2003-10-02

Regulatory Status

RX

2003
02 Oct
RX Application: 40416

Drug Name

JANTOVEN

Product Number

8

Dosage Form

-

Strength

7.5MG

Approval Date

2003-10-02

40416 / 8

Active Ingredient

WARFARIN SODIUM

Application Number

40416

Product Number

8

Dosage Form

-

Strength

7.5MG

Approval Date

2003-10-02

Regulatory Status

RX

2003
02 Oct
RX Application: 40416

Drug Name

JANTOVEN

Product Number

9

Dosage Form

-

Strength

10MG

Approval Date

2003-10-02

40416 / 9

Active Ingredient

WARFARIN SODIUM

Application Number

40416

Product Number

9

Dosage Form

-

Strength

10MG

Approval Date

2003-10-02

Regulatory Status

RX

1986
17 Apr
RX Application: 19123

Drug Name

KLOR-CON

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

1986-04-17

19123 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

19123

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

1986-04-17

Regulatory Status

RX

1986
17 Apr
RX Application: 19123

Drug Name

KLOR-CON

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

1986-04-17

19123 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

19123

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

1986-04-17

Regulatory Status

RX

2015
10 Jul
Discontinued Application: 203106

Drug Name

KLOR-CON

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2015-07-10

203106 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

203106

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2015-07-10

Regulatory Status

Discontinued

2015
10 Jul
Discontinued Application: 203106

Drug Name

KLOR-CON

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2015-07-10

203106 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

203106

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2015-07-10

Regulatory Status

Discontinued

2017
23 Oct
RX Application: 209662

Drug Name

KLOR-CON

Product Number

1

Dosage Form

-

Strength

20MEQ

Approval Date

2017-10-23

209662 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

209662

Product Number

1

Dosage Form

-

Strength

20MEQ

Approval Date

2017-10-23

Regulatory Status

RX

2000
09 Aug
RX Application: 74726

Drug Name

KLOR-CON M10

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2000-08-09

74726 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

74726

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2000-08-09

Regulatory Status

RX

2003
06 Jun
RX Application: 74726

Drug Name

KLOR-CON M15

Product Number

3

Dosage Form

-

Strength

15MEQ

Approval Date

2003-06-06

74726 / 3

Active Ingredient

POTASSIUM CHLORIDE

Application Number

74726

Product Number

3

Dosage Form

-

Strength

15MEQ

Approval Date

2003-06-06

Regulatory Status

RX

1998
20 Nov
RX Application: 74726

Drug Name

KLOR-CON M20

Product Number

1

Dosage Form

-

Strength

20MEQ

Approval Date

1998-11-20

74726 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

74726

Product Number

1

Dosage Form

-

Strength

20MEQ

Approval Date

1998-11-20

Regulatory Status

RX

1984
26 Jul
Discontinued Application: 88484

Drug Name

MEDROXYPROGESTERONE ACETATE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1984-07-26

88484 / 1

Active Ingredient

MEDROXYPROGESTERONE ACETATE

Application Number

88484

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1984-07-26

Regulatory Status

Discontinued

2015
31 Jul
RX Application: 90043

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-07-31

90043 / 1

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

90043

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-07-31

Regulatory Status

RX

2015
31 Jul
RX Application: 90043

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-07-31

90043 / 2

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

90043

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-07-31

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 87453

Drug Name

METHOCARBAMOL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

87453 / 1

Active Ingredient

METHOCARBAMOL

Application Number

87453

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87454

Drug Name

METHOCARBAMOL

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

1982-01-01

87454 / 1

Active Ingredient

METHOCARBAMOL

Application Number

87454

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2003
19 Jun
Discontinued Application: 76189

Drug Name

MIRTAZAPINE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2003-06-19

76189 / 1

Active Ingredient

MIRTAZAPINE

Application Number

76189

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2003-06-19

Regulatory Status

Discontinued

2003
19 Jun
Discontinued Application: 76189

Drug Name

MIRTAZAPINE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2003-06-19

76189 / 2

Active Ingredient

MIRTAZAPINE

Application Number

76189

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2003-06-19

Regulatory Status

Discontinued

2003
19 Jun
Discontinued Application: 76189

Drug Name

MIRTAZAPINE

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2003-06-19

76189 / 3

Active Ingredient

MIRTAZAPINE

Application Number

76189

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2003-06-19

Regulatory Status

Discontinued

2013
03 Jun
RX Application: 202104

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2013-06-03

202104 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

202104

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2013-06-03

Regulatory Status

RX

2013
03 Jun
RX Application: 202104

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2013-06-03

202104 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

202104

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2013-06-03

Regulatory Status

RX

2013
03 Jun
RX Application: 202104

Drug Name

MORPHINE SULFATE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2013-06-03

202104 / 3

Active Ingredient

MORPHINE SULFATE

Application Number

202104

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2013-06-03

Regulatory Status

RX

2013
03 Jun
RX Application: 202104

Drug Name

MORPHINE SULFATE

Product Number

4

Dosage Form

-

Strength

50MG

Approval Date

2013-06-03

202104 / 4

Active Ingredient

MORPHINE SULFATE

Application Number

202104

Product Number

4

Dosage Form

-

Strength

50MG

Approval Date

2013-06-03

Regulatory Status

RX

2013
03 Jun
RX Application: 202104

Drug Name

MORPHINE SULFATE

Product Number

5

Dosage Form

-

Strength

60MG

Approval Date

2013-06-03

202104 / 5

Active Ingredient

MORPHINE SULFATE

Application Number

202104

Product Number

5

Dosage Form

-

Strength

60MG

Approval Date

2013-06-03

Regulatory Status

RX

2013
03 Jun
RX Application: 202104

Drug Name

MORPHINE SULFATE

Product Number

6

Dosage Form

-

Strength

80MG

Approval Date

2013-06-03

202104 / 6

Active Ingredient

MORPHINE SULFATE

Application Number

202104

Product Number

6

Dosage Form

-

Strength

80MG

Approval Date

2013-06-03

Regulatory Status

RX

2013
03 Jun
RX Application: 202104

Drug Name

MORPHINE SULFATE

Product Number

7

Dosage Form

-

Strength

100MG

Approval Date

2013-06-03

202104 / 7

Active Ingredient

MORPHINE SULFATE

Application Number

202104

Product Number

7

Dosage Form

-

Strength

100MG

Approval Date

2013-06-03

Regulatory Status

RX

2019
22 Jul
RX Application: 210610

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2019-07-22

210610 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

210610

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2019-07-22

Regulatory Status

RX

2019
22 Jul
RX Application: 210610

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2019-07-22

210610 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

210610

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2019-07-22

Regulatory Status

RX

2021
10 Feb
RX Application: 212616

Drug Name

MOXIFLOXACIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2021-02-10

212616 / 1

Active Ingredient

MOXIFLOXACIN HYDROCHLORIDE

Application Number

212616

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2021-02-10

Regulatory Status

RX

2012
19 Jan
RX Application: 76485

Drug Name

MYORISAN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2012-01-19

76485 / 1

Active Ingredient

ISOTRETINOIN

Application Number

76485

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2012-01-19

Regulatory Status

RX

2012
19 Jan
RX Application: 76485

Drug Name

MYORISAN

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2012-01-19

76485 / 2

Active Ingredient

ISOTRETINOIN

Application Number

76485

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2012-01-19

Regulatory Status

RX

2012
19 Jan
RX Application: 76485

Drug Name

MYORISAN

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2012-01-19

76485 / 3

Active Ingredient

ISOTRETINOIN

Application Number

76485

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2012-01-19

Regulatory Status

RX

2015
25 Aug
RX Application: 76485

Drug Name

MYORISAN

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2015-08-25

76485 / 4

Active Ingredient

ISOTRETINOIN

Application Number

76485

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2015-08-25

Regulatory Status

RX

2005
03 May
RX Application: 65183

Drug Name

NYSTATIN

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM

Approval Date

2005-05-03

65183 / 1

Active Ingredient

NYSTATIN

Application Number

65183

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM

Approval Date

2005-05-03

Regulatory Status

RX

2026
22 Jan
Discontinued Application: 213437

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2026-01-22

213437 / 1

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

213437

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2026-01-22

Regulatory Status

Discontinued

2026
22 Jan
Discontinued Application: 213437

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

2

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2026-01-22

213437 / 2

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

213437

Product Number

2

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2026-01-22

Regulatory Status

Discontinued

2026
22 Jan
Discontinued Application: 213437

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2026-01-22

213437 / 3

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

213437

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2026-01-22

Regulatory Status

Discontinued

2006
01 Dec
Discontinued Application: 76761

Drug Name

OXANDROLONE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2006-12-01

76761 / 1

Active Ingredient

OXANDROLONE

Application Number

76761

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2006-12-01

Regulatory Status

Discontinued

2007
22 Mar
Discontinued Application: 78033

Drug Name

OXANDROLONE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2007-03-22

78033 / 1

Active Ingredient

OXANDROLONE

Application Number

78033

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2007-03-22

Regulatory Status

Discontinued

1998
30 Apr
RX Application: 75135

Drug Name

PACERONE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1998-04-30

75135 / 1

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

75135

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1998-04-30

Regulatory Status

RX

2005
12 Apr
RX Application: 75135

Drug Name

PACERONE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2005-04-12

75135 / 2

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

75135

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2005-04-12

Regulatory Status

RX

2020
02 Jul
RX Application: 75135

Drug Name

PACERONE

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2020-07-02

75135 / 3

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

75135

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2020-07-02

Regulatory Status

RX

2004
08 Mar
Discontinued Application: 75566

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2004-03-08

75566 / 1

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

75566

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2004-03-08

Regulatory Status

Discontinued

2004
08 Mar
Discontinued Application: 75566

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2004-03-08

75566 / 2

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

75566

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2004-03-08

Regulatory Status

Discontinued

2004
08 Mar
Discontinued Application: 75566

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2004-03-08

75566 / 3

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

75566

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2004-03-08

Regulatory Status

Discontinued

2004
08 Mar
Discontinued Application: 75566

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2004-03-08

75566 / 4

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

75566

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2004-03-08

Regulatory Status

Discontinued

1999
31 Mar
Discontinued Application: 74962

Drug Name

PENTOXIL

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1999-03-31

74962 / 1

Active Ingredient

PENTOXIFYLLINE

Application Number

74962

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1999-03-31

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84399

Drug Name

PHENDIMETRAZINE TARTRATE

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

84399 / 1

Active Ingredient

PHENDIMETRAZINE TARTRATE

Application Number

84399

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
09 Apr
Discontinued Application: 84487

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-04-09

84487 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

84487

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-04-09

Regulatory Status

Discontinued

1984
27 Mar
Discontinued Application: 88430

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1984-03-27

88430 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

88430

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1984-03-27

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87470

Drug Name

PREDNISONE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

87470 / 1

Active Ingredient

PREDNISONE

Application Number

87470

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87471

Drug Name

PREDNISONE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

87471 / 1

Active Ingredient

PREDNISONE

Application Number

87471

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2020
25 Jun
RX Application: 212744

Drug Name

PROPAFENONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

225MG

Approval Date

2020-06-25

212744 / 1

Active Ingredient

PROPAFENONE HYDROCHLORIDE

Application Number

212744

Product Number

1

Dosage Form

-

Strength

225MG

Approval Date

2020-06-25

Regulatory Status

RX

2020
25 Jun
RX Application: 212744

Drug Name

PROPAFENONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

325MG

Approval Date

2020-06-25

212744 / 2

Active Ingredient

PROPAFENONE HYDROCHLORIDE

Application Number

212744

Product Number

2

Dosage Form

-

Strength

325MG

Approval Date

2020-06-25

Regulatory Status

RX

2020
25 Jun
RX Application: 212744

Drug Name

PROPAFENONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

425MG

Approval Date

2020-06-25

212744 / 3

Active Ingredient

PROPAFENONE HYDROCHLORIDE

Application Number

212744

Product Number

3

Dosage Form

-

Strength

425MG

Approval Date

2020-06-25

Regulatory Status

RX

2009
06 Mar
Discontinued Application: 78311

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2009-03-06

78311 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

78311

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2009-03-06

Regulatory Status

Discontinued

2009
06 Mar
Discontinued Application: 78311

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2009-03-06

78311 / 2

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

78311

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2009-03-06

Regulatory Status

Discontinued

2009
06 Mar
Discontinued Application: 78311

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

2009-03-06

78311 / 3

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

78311

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

2009-03-06

Regulatory Status

Discontinued

2009
06 Mar
Discontinued Application: 78311

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

160MG

Approval Date

2009-03-06

78311 / 4

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

78311

Product Number

4

Dosage Form

-

Strength

160MG

Approval Date

2009-03-06

Regulatory Status

Discontinued

2014
11 Mar
RX Application: 205122

Drug Name

QUDEXY XR

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2014-03-11

205122 / 1

Active Ingredient

TOPIRAMATE

Application Number

205122

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2014-03-11

Regulatory Status

RX

2014
11 Mar
RX Application: 205122

Drug Name

QUDEXY XR

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2014-03-11

205122 / 2

Active Ingredient

TOPIRAMATE

Application Number

205122

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2014-03-11

Regulatory Status

RX

2014
11 Mar
RX Application: 205122

Drug Name

QUDEXY XR

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2014-03-11

205122 / 3

Active Ingredient

TOPIRAMATE

Application Number

205122

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2014-03-11

Regulatory Status

RX

2014
11 Mar
RX Application: 205122

Drug Name

QUDEXY XR

Product Number

4

Dosage Form

-

Strength

150MG

Approval Date

2014-03-11

205122 / 4

Active Ingredient

TOPIRAMATE

Application Number

205122

Product Number

4

Dosage Form

-

Strength

150MG

Approval Date

2014-03-11

Regulatory Status

RX

2014
11 Mar
RX Application: 205122

Drug Name

QUDEXY XR

Product Number

5

Dosage Form

-

Strength

200MG

Approval Date

2014-03-11

205122 / 5

Active Ingredient

TOPIRAMATE

Application Number

205122

Product Number

5

Dosage Form

-

Strength

200MG

Approval Date

2014-03-11

Regulatory Status

RX

2011
21 Dec
RX Application: 90313

Drug Name

SODIUM POLYSTYRENE SULFONATE

Product Number

1

Dosage Form

-

Strength

453.6GM/BOT

Approval Date

2011-12-21

90313 / 1

Active Ingredient

SODIUM POLYSTYRENE SULFONATE

Application Number

90313

Product Number

1

Dosage Form

-

Strength

453.6GM/BOT

Approval Date

2011-12-21

Regulatory Status

RX

2000
01 May
Discontinued Application: 75366

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2000-05-01

75366 / 1

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

75366

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2000-05-01

Regulatory Status

Discontinued

2000
01 May
Discontinued Application: 75366

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2000-05-01

75366 / 2

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

75366

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2000-05-01

Regulatory Status

Discontinued

2000
01 May
Discontinued Application: 75366

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2000-05-01

75366 / 3

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

75366

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2000-05-01

Regulatory Status

Discontinued

2000
01 May
Discontinued Application: 75366

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

240MG

Approval Date

2000-05-01

75366 / 4

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

75366

Product Number

4

Dosage Form

-

Strength

240MG

Approval Date

2000-05-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87554

Drug Name

SPIRONOLACTONE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

87554 / 1

Active Ingredient

SPIRONOLACTONE

Application Number

87554

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87553

Drug Name

SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG;25MG

Approval Date

1982-01-01

87553 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

Application Number

87553

Product Number

1

Dosage Form

-

Strength

25MG;25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2015
29 Apr
Discontinued Application: 91635

Drug Name

TROSPIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2015-04-29

91635 / 1

Active Ingredient

TROSPIUM CHLORIDE

Application Number

91635

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2015-04-29

Regulatory Status

Discontinued

2023
29 Jun
RX Application: 214749

Drug Name

VIGABATRIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2023-06-29

214749 / 1

Active Ingredient

VIGABATRIN

Application Number

214749

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2023-06-29

Regulatory Status

RX

2014
04 Jun
RX Application: 204399

Drug Name

VOGELXO

Product Number

2

Dosage Form

-

Strength

50MG/5GM PACKET

Approval Date

2014-06-04

204399 / 2

Active Ingredient

TESTOSTERONE

Application Number

204399

Product Number

2

Dosage Form

-

Strength

50MG/5GM PACKET

Approval Date

2014-06-04

Regulatory Status

RX

2014
04 Jun
RX Application: 204399

Drug Name

VOGELXO

Product Number

3

Dosage Form

-

Strength

12.5MG/1.25GM ACTUATION

Approval Date

2014-06-04

204399 / 3

Active Ingredient

TESTOSTERONE

Application Number

204399

Product Number

3

Dosage Form

-

Strength

12.5MG/1.25GM ACTUATION

Approval Date

2014-06-04

Regulatory Status

RX

2008
06 Jun
Discontinued Application: 78095

Drug Name

ZALEPLON

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-06-06

78095 / 1

Active Ingredient

ZALEPLON

Application Number

78095

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-06-06

Regulatory Status

Discontinued

2008
06 Jun
Discontinued Application: 78095

Drug Name

ZALEPLON

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-06-06

78095 / 2

Active Ingredient

ZALEPLON

Application Number

78095

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-06-06

Regulatory Status

Discontinued

2008
06 Jun
Discontinued Application: 78706

Drug Name

ZALEPLON

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-06-06

78706 / 1

Active Ingredient

ZALEPLON

Application Number

78706

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-06-06

Regulatory Status

Discontinued

2008
06 Jun
Discontinued Application: 78706

Drug Name

ZALEPLON

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-06-06

78706 / 2

Active Ingredient

ZALEPLON

Application Number

78706

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-06-06

Regulatory Status

Discontinued

2005
22 Dec
Discontinued Application: 77644

Drug Name

ZONISAMIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2005-12-22

77644 / 1

Active Ingredient

ZONISAMIDE

Application Number

77644

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2005-12-22

Regulatory Status

Discontinued

2005
22 Dec
Discontinued Application: 77644

Drug Name

ZONISAMIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2005-12-22

77644 / 2

Active Ingredient

ZONISAMIDE

Application Number

77644

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2005-12-22

Regulatory Status

Discontinued

2005
22 Dec
Discontinued Application: 77644

Drug Name

ZONISAMIDE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2005-12-22

77644 / 3

Active Ingredient

ZONISAMIDE

Application Number

77644

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2005-12-22

Regulatory Status

Discontinued

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Drug Status Breakdown
162 total
  • RX
  • Discontinued
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

AMANTADINE HYDROCHLORIDE

Application Number

70589

Product Number

1

Active Ingredient

AMANTADINE HYDROCHLORIDE

Dosage Form

-

Strength

100MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

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Organized FDA drug records

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