Upsher-Smith Laboratories RX
FDA Approved Drugs

Upsher-Smith Laboratories RX

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
  • Total Records 87
  • Latest Approval Date Jan 06, 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 RX

Country

U.S.A

Website

Visit Website

Email

uslinfo@upsher-smith.com

Social Profiles

Company Snapshot

Upsher-Smith Laboratories RX

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 ( 87 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

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

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

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
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

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

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

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

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

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

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

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

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

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

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

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

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

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

Related Databases
  • FDA Inspections
    0 View
  • EDQM CEP
    0 View
  • KDMF
    0 View
  • Japan DMF
    0 View
  • Eudra GMP
    0 View
  • NDC Database
    0 View
  • FDA Approved Drugs Database
    162 View
  • Drug Prices in Switzerland
    0 View
Drug Status Breakdown
87 total
  • RX
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

Reliable Data

Organized FDA drug records

Create a New Buying Request

Fields marked with * are mandatory.

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