Bionpharma
FDA Approved Drugs

Bionpharma

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 OTC Discontinued
  • Total Records 126
  • Latest Approval Date Dec 23, 2025
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
126
View
Discontinued
13
View
OTC
15
View
RX
98
View
Company Overview

Company

Bionpharma

Country

U.S.A

Website

Visit Website

Email

admin@bionpharma.com

Social Profiles

Company Snapshot

Bionpharma

Suite 2-4B, 600 Alexander Road, Princeton, NJ 08540

U.S.A

www.bionpharma.com/index.html admin@bionpharma.com View on Map
FDA Approved Drug Records ( 126 records )
2025
18 Sep
RX Application: 219904

Drug Name

ACAMPROSATE CALCIUM

Product Number

1

Dosage Form

-

Strength

333MG

Approval Date

2025-09-18

219904 / 1

Active Ingredient

ACAMPROSATE CALCIUM

Application Number

219904

Product Number

1

Dosage Form

-

Strength

333MG

Approval Date

2025-09-18

Regulatory Status

RX

2023
01 Aug
OTC Application: 216999

Drug Name

ACETAMINOPHEN AND IBUPROFEN

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

2023-08-01

216999 / 1

Active Ingredient

ACETAMINOPHEN; IBUPROFEN

Application Number

216999

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

2023-08-01

Regulatory Status

OTC

2008
29 May
RX Application: 78720

Drug Name

AMANTADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2008-05-29

78720 / 1

Active Ingredient

AMANTADINE HYDROCHLORIDE

Application Number

78720

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2008-05-29

Regulatory Status

RX

2019
22 Nov
RX Application: 212919

Drug Name

AMPHETAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-11-22

212919 / 1

Active Ingredient

AMPHETAMINE SULFATE

Application Number

212919

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-11-22

Regulatory Status

RX

2019
22 Nov
RX Application: 212919

Drug Name

AMPHETAMINE SULFATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-11-22

212919 / 2

Active Ingredient

AMPHETAMINE SULFATE

Application Number

212919

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-11-22

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 80429

Drug Name

ANESTACON

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

80429 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

80429

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

Regulatory Status

Discontinued

2020
08 Apr
Discontinued Application: 210152

Drug Name

APIXABAN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2020-04-08

210152 / 1

Active Ingredient

APIXABAN

Application Number

210152

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2020-04-08

Regulatory Status

Discontinued

2020
08 Apr
Discontinued Application: 210152

Drug Name

APIXABAN

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2020-04-08

210152 / 2

Active Ingredient

APIXABAN

Application Number

210152

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2020-04-08

Regulatory Status

Discontinued

2021
30 Mar
RX Application: 212918

Drug Name

ATOVAQUONE

Product Number

1

Dosage Form

-

Strength

750MG/5ML

Approval Date

2021-03-30

212918 / 1

Active Ingredient

ATOVAQUONE

Application Number

212918

Product Number

1

Dosage Form

-

Strength

750MG/5ML

Approval Date

2021-03-30

Regulatory Status

RX

2015
28 Jul
Discontinued Application: 90176

Drug Name

AZELASTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.137MG/SPRAY

Approval Date

2015-07-28

90176 / 1

Active Ingredient

AZELASTINE HYDROCHLORIDE

Application Number

90176

Product Number

1

Dosage Form

-

Strength

0.137MG/SPRAY

Approval Date

2015-07-28

Regulatory Status

Discontinued

2018
26 Dec
RX Application: 209999

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE

Approval Date

2018-12-26

209999 / 1

Active Ingredient

AZITHROMYCIN

Application Number

209999

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE

Approval Date

2018-12-26

Regulatory Status

RX

2019
26 Feb
RX Application: 210000

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2019-02-26

210000 / 1

Active Ingredient

AZITHROMYCIN

Application Number

210000

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2019-02-26

Regulatory Status

RX

2019
26 Feb
RX Application: 210001

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2019-02-26

210001 / 1

Active Ingredient

AZITHROMYCIN

Application Number

210001

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2019-02-26

Regulatory Status

RX

1993
29 Jan
RX Application: 81297

Drug Name

BENZONATATE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1993-01-29

81297 / 1

Active Ingredient

BENZONATATE

Application Number

81297

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1993-01-29

Regulatory Status

RX

2007
30 Oct
RX Application: 81297

Drug Name

BENZONATATE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2007-10-30

81297 / 2

Active Ingredient

BENZONATATE

Application Number

81297

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2007-10-30

Regulatory Status

RX

2014
12 Aug
RX Application: 203174

Drug Name

BEXAROTENE

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2014-08-12

203174 / 1

Active Ingredient

BEXAROTENE

Application Number

203174

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2014-08-12

Regulatory Status

RX

2020
30 Sep
RX Application: 203997

Drug Name

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

2MG/5ML;10MG/5ML;30MG/5ML

Approval Date

2020-09-30

203997 / 1

Active Ingredient

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

203997

Product Number

1

Dosage Form

-

Strength

2MG/5ML;10MG/5ML;30MG/5ML

Approval Date

2020-09-30

Regulatory Status

RX

2013
24 May
RX Application: 91174

Drug Name

CALCITRIOL

Product Number

1

Dosage Form

-

Strength

0.25MCG

Approval Date

2013-05-24

91174 / 1

Active Ingredient

CALCITRIOL

Application Number

91174

Product Number

1

Dosage Form

-

Strength

0.25MCG

Approval Date

2013-05-24

Regulatory Status

RX

2013
24 May
RX Application: 91174

Drug Name

CALCITRIOL

Product Number

2

Dosage Form

-

Strength

0.5MCG

Approval Date

2013-05-24

91174 / 2

Active Ingredient

CALCITRIOL

Application Number

91174

Product Number

2

Dosage Form

-

Strength

0.5MCG

Approval Date

2013-05-24

Regulatory Status

RX

2024
16 Feb
RX Application: 218221

Drug Name

CARBAMAZEPINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2024-02-16

218221 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

218221

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2024-02-16

Regulatory Status

RX

2008
06 Oct
RX Application: 78488

Drug Name

CETIRIZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2008-10-06

78488 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

78488

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2008-10-06

Regulatory Status

RX

2009
23 Jul
OTC Application: 22429

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-07-23

22429 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

22429

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-07-23

Regulatory Status

OTC

2009
23 Jul
OTC Application: 22429

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2009-07-23

22429 / 4

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

22429

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2009-07-23

Regulatory Status

OTC

2009
23 Jul
OTC Application: 22429

Drug Name

CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2009-07-23

22429 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

22429

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2009-07-23

Regulatory Status

OTC

2009
23 Jul
OTC Application: 22429

Drug Name

CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2009-07-23

22429 / 3

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

22429

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2009-07-23

Regulatory Status

OTC

2023
08 Nov
RX Application: 218290

Drug Name

CEVIMELINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2023-11-08

218290 / 1

Active Ingredient

CEVIMELINE HYDROCHLORIDE

Application Number

218290

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2023-11-08

Regulatory Status

RX

2024
07 Nov
RX Application: 218220

Drug Name

CIMETIDINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2024-11-07

218220 / 1

Active Ingredient

CIMETIDINE

Application Number

218220

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2024-11-07

Regulatory Status

RX

2024
07 Nov
RX Application: 218220

Drug Name

CIMETIDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2024-11-07

218220 / 2

Active Ingredient

CIMETIDINE

Application Number

218220

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2024-11-07

Regulatory Status

RX

2024
07 Nov
RX Application: 218220

Drug Name

CIMETIDINE

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2024-11-07

218220 / 3

Active Ingredient

CIMETIDINE

Application Number

218220

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2024-11-07

Regulatory Status

RX

2024
07 Nov
RX Application: 218220

Drug Name

CIMETIDINE

Product Number

4

Dosage Form

-

Strength

800MG

Approval Date

2024-11-07

218220 / 4

Active Ingredient

CIMETIDINE

Application Number

218220

Product Number

4

Dosage Form

-

Strength

800MG

Approval Date

2024-11-07

Regulatory Status

RX

2018
22 Oct
RX Application: 208819

Drug Name

CLOBAZAM

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2018-10-22

208819 / 1

Active Ingredient

CLOBAZAM

Application Number

208819

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2018-10-22

Regulatory Status

RX

2018
22 Oct
RX Application: 208825

Drug Name

CLOBAZAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-10-22

208825 / 1

Active Ingredient

CLOBAZAM

Application Number

208825

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-10-22

Regulatory Status

RX

2018
22 Oct
RX Application: 208825

Drug Name

CLOBAZAM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-10-22

208825 / 2

Active Ingredient

CLOBAZAM

Application Number

208825

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-10-22

Regulatory Status

RX

2019
13 Sep
RX Application: 208670

Drug Name

COLESEVELAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

625MG

Approval Date

2019-09-13

208670 / 1

Active Ingredient

COLESEVELAM HYDROCHLORIDE

Application Number

208670

Product Number

1

Dosage Form

-

Strength

625MG

Approval Date

2019-09-13

Regulatory Status

RX

2019
20 Nov
RX Application: 210920

Drug Name

DEFERASIROX

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2019-11-20

210920 / 1

Active Ingredient

DEFERASIROX

Application Number

210920

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2019-11-20

Regulatory Status

RX

2019
20 Nov
RX Application: 210920

Drug Name

DEFERASIROX

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2019-11-20

210920 / 2

Active Ingredient

DEFERASIROX

Application Number

210920

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2019-11-20

Regulatory Status

RX

2019
20 Nov
RX Application: 210920

Drug Name

DEFERASIROX

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2019-11-20

210920 / 3

Active Ingredient

DEFERASIROX

Application Number

210920

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2019-11-20

Regulatory Status

RX

2023
19 Apr
RX Application: 217001

Drug Name

DEXAMETHASONE

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2023-04-19

217001 / 1

Active Ingredient

DEXAMETHASONE

Application Number

217001

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2023-04-19

Regulatory Status

RX

2023
19 Apr
RX Application: 217001

Drug Name

DEXAMETHASONE

Product Number

2

Dosage Form

-

Strength

6MG

Approval Date

2023-04-19

217001 / 2

Active Ingredient

DEXAMETHASONE

Application Number

217001

Product Number

2

Dosage Form

-

Strength

6MG

Approval Date

2023-04-19

Regulatory Status

RX

2023
26 Apr
RX Application: 217538

Drug Name

DEXAMETHASONE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2023-04-26

217538 / 1

Active Ingredient

DEXAMETHASONE

Application Number

217538

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2023-04-26

Regulatory Status

RX

2020
24 Mar
Discontinued Application: 209754

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2020-03-24

209754 / 1

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

209754

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2020-03-24

Regulatory Status

Discontinued

2020
24 Mar
Discontinued Application: 209754

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2020-03-24

209754 / 2

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

209754

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2020-03-24

Regulatory Status

Discontinued

2016
23 Feb
RX Application: 204648

Drug Name

DICLOFENAC POTASSIUM

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2016-02-23

204648 / 1

Active Ingredient

DICLOFENAC POTASSIUM

Application Number

204648

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2016-02-23

Regulatory Status

RX

2023
04 Aug
RX Application: 217916

Drug Name

DICYCLOMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2023-08-04

217916 / 1

Active Ingredient

DICYCLOMINE HYDROCHLORIDE

Application Number

217916

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2023-08-04

Regulatory Status

RX

2018
10 Apr
RX Application: 208625

Drug Name

DOFETILIDE

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2018-04-10

208625 / 1

Active Ingredient

DOFETILIDE

Application Number

208625

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2018-04-10

Regulatory Status

RX

2018
10 Apr
RX Application: 208625

Drug Name

DOFETILIDE

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2018-04-10

208625 / 2

Active Ingredient

DOFETILIDE

Application Number

208625

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2018-04-10

Regulatory Status

RX

2018
10 Apr
RX Application: 208625

Drug Name

DOFETILIDE

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2018-04-10

208625 / 3

Active Ingredient

DOFETILIDE

Application Number

208625

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2018-04-10

Regulatory Status

RX

2020
10 Dec
Discontinued Application: 209393

Drug Name

DOXYCYCLINE HYCLATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2020-12-10

209393 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

209393

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2020-12-10

Regulatory Status

Discontinued

2020
10 Dec
Discontinued Application: 209393

Drug Name

DOXYCYCLINE HYCLATE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2020-12-10

209393 / 2

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

209393

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2020-12-10

Regulatory Status

Discontinued

2023
04 Aug
RX Application: 217000

Drug Name

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG;10MG

Approval Date

2023-08-04

217000 / 1

Active Ingredient

DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

Application Number

217000

Product Number

1

Dosage Form

-

Strength

10MG;10MG

Approval Date

2023-08-04

Regulatory Status

RX

2021
28 Apr
RX Application: 213033

Drug Name

DROXIDOPA

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2021-04-28

213033 / 1

Active Ingredient

DROXIDOPA

Application Number

213033

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2021-04-28

Regulatory Status

RX

2021
28 Apr
RX Application: 213033

Drug Name

DROXIDOPA

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2021-04-28

213033 / 2

Active Ingredient

DROXIDOPA

Application Number

213033

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2021-04-28

Regulatory Status

RX

2021
28 Apr
RX Application: 213033

Drug Name

DROXIDOPA

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2021-04-28

213033 / 3

Active Ingredient

DROXIDOPA

Application Number

213033

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2021-04-28

Regulatory Status

RX

2021
10 Aug
RX Application: 212408

Drug Name

ENALAPRIL MALEATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2021-08-10

212408 / 1

Active Ingredient

ENALAPRIL MALEATE

Application Number

212408

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2021-08-10

Regulatory Status

RX

2002
28 Oct
RX Application: 40430

Drug Name

ETHOSUXIMIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2002-10-28

40430 / 1

Active Ingredient

ETHOSUXIMIDE

Application Number

40430

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2002-10-28

Regulatory Status

RX

2025
02 Oct
RX Application: 219152

Drug Name

ETRAVIRINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2025-10-02

219152 / 1

Active Ingredient

ETRAVIRINE

Application Number

219152

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2025-10-02

Regulatory Status

RX

2025
02 Oct
RX Application: 219152

Drug Name

ETRAVIRINE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2025-10-02

219152 / 2

Active Ingredient

ETRAVIRINE

Application Number

219152

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2025-10-02

Regulatory Status

RX

2025
23 Jun
Discontinued Application: 219153

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

2025-06-23

219153 / 1

Active Ingredient

FAMOTIDINE

Application Number

219153

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

2025-06-23

Regulatory Status

Discontinued

2023
24 May
RX Application: 210252

Drug Name

FINGOLIMOD HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2023-05-24

210252 / 1

Active Ingredient

FINGOLIMOD HYDROCHLORIDE

Application Number

210252

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2023-05-24

Regulatory Status

RX

2020
11 May
RX Application: 212182

Drug Name

FLUVOXAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2020-05-11

212182 / 1

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

212182

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2020-05-11

Regulatory Status

RX

2020
16 Sep
RX Application: 212182

Drug Name

FLUVOXAMINE MALEATE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2020-09-16

212182 / 2

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

212182

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2020-09-16

Regulatory Status

RX

2024
22 Jan
RX Application: 217917

Drug Name

FLUVOXAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2024-01-22

217917 / 1

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

217917

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2024-01-22

Regulatory Status

RX

2024
22 Jan
RX Application: 217917

Drug Name

FLUVOXAMINE MALEATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2024-01-22

217917 / 2

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

217917

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2024-01-22

Regulatory Status

RX

2024
22 Jan
RX Application: 217917

Drug Name

FLUVOXAMINE MALEATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2024-01-22

217917 / 3

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

217917

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2024-01-22

Regulatory Status

RX

2025
23 Dec
RX Application: 220062

Drug Name

GLYCOPYRROLATE

Product Number

1

Dosage Form

-

Strength

1MG/5ML

Approval Date

2025-12-23

220062 / 1

Active Ingredient

GLYCOPYRROLATE

Application Number

220062

Product Number

1

Dosage Form

-

Strength

1MG/5ML

Approval Date

2025-12-23

Regulatory Status

RX

2008
30 Jun
RX Application: 78863

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

Approval Date

2008-06-30

78863 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

78863

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

Approval Date

2008-06-30

Regulatory Status

RX

2008
30 Jun
RX Application: 78880

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

Approval Date

2008-06-30

78880 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

78880

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

Approval Date

2008-06-30

Regulatory Status

RX

2008
30 Jun
RX Application: 78863

Drug Name

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

Approval Date

2008-06-30

78863 / 2

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

78863

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

Approval Date

2008-06-30

Regulatory Status

RX

2025
28 Apr
RX Application: 219289

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

2025-04-28

219289 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

219289

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

2025-04-28

Regulatory Status

RX

2009
24 Mar
OTC Application: 78682

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

EQ 200MG FREE ACID AND POTASSIUM SALT

Approval Date

2009-03-24

78682 / 1

Active Ingredient

IBUPROFEN

Application Number

78682

Product Number

1

Dosage Form

-

Strength

EQ 200MG FREE ACID AND POTASSIUM SALT

Approval Date

2009-03-24

Regulatory Status

OTC

2010
22 Nov
OTC Application: 90397

Drug Name

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG;EQ 200MG FREE ACID AND POTASSIUM SALT

Approval Date

2010-11-22

90397 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

Application Number

90397

Product Number

1

Dosage Form

-

Strength

25MG;EQ 200MG FREE ACID AND POTASSIUM SALT

Approval Date

2010-11-22

Regulatory Status

OTC

2024
05 Sep
RX Application: 213276

Drug Name

IVABRADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2024-09-05

213276 / 1

Active Ingredient

IVABRADINE HYDROCHLORIDE

Application Number

213276

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2024-09-05

Regulatory Status

RX

2024
05 Sep
RX Application: 213276

Drug Name

IVABRADINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 7.5MG BASE

Approval Date

2024-09-05

213276 / 2

Active Ingredient

IVABRADINE HYDROCHLORIDE

Application Number

213276

Product Number

2

Dosage Form

-

Strength

EQ 7.5MG BASE

Approval Date

2024-09-05

Regulatory Status

RX

2023
23 Feb
RX Application: 216759

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-02-23

216759 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

216759

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-02-23

Regulatory Status

RX

2009
16 Jan
RX Application: 79120

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2009-01-16

79120 / 1

Active Ingredient

LEVETIRACETAM

Application Number

79120

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2009-01-16

Regulatory Status

RX

2005
04 Aug
OTC Application: 21855

Drug Name

LOPERAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2005-08-04

21855 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE

Application Number

21855

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2005-08-04

Regulatory Status

OTC

2005
04 Aug
OTC Application: 21855

Drug Name

LOPERAMIDE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2005-08-04

21855 / 2

Active Ingredient

LOPERAMIDE HYDROCHLORIDE

Application Number

21855

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2005-08-04

Regulatory Status

OTC

2021
22 Oct
RX Application: 215579

Drug Name

LOPERAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2021-10-22

215579 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE

Application Number

215579

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2021-10-22

Regulatory Status

RX

2025
19 Sep
OTC Application: 220100

Drug Name

LOPERAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG/7.5ML

Approval Date

2025-09-19

220100 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE

Application Number

220100

Product Number

1

Dosage Form

-

Strength

1MG/7.5ML

Approval Date

2025-09-19

Regulatory Status

OTC

2021
10 Sep
OTC Application: 213484

Drug Name

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

Product Number

1

Dosage Form

-

Strength

2MG;125MG

Approval Date

2021-09-10

213484 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

Application Number

213484

Product Number

1

Dosage Form

-

Strength

2MG;125MG

Approval Date

2021-09-10

Regulatory Status

OTC

2018
21 Dec
OTC Application: 202538

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-12-21

202538 / 1

Active Ingredient

LORATADINE

Application Number

202538

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-12-21

Regulatory Status

OTC

2024
14 May
OTC Application: 218017

Drug Name

LORATADINE AND PSEUDOEPHEDRINE SULFATE

Product Number

1

Dosage Form

-

Strength

10MG;240MG

Approval Date

2024-05-14

218017 / 1

Active Ingredient

LORATADINE; PSEUDOEPHEDRINE SULFATE

Application Number

218017

Product Number

1

Dosage Form

-

Strength

10MG;240MG

Approval Date

2024-05-14

Regulatory Status

OTC

2025
14 Apr
RX Application: 219151

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG/5ML

Approval Date

2025-04-14

219151 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

219151

Product Number

1

Dosage Form

-

Strength

500MG/5ML

Approval Date

2025-04-14

Regulatory Status

RX

2023
25 Sep
RX Application: 218149

Drug Name

METHIMAZOLE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2023-09-25

218149 / 1

Active Ingredient

METHIMAZOLE

Application Number

218149

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2023-09-25

Regulatory Status

RX

2023
25 Sep
RX Application: 218149

Drug Name

METHIMAZOLE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2023-09-25

218149 / 2

Active Ingredient

METHIMAZOLE

Application Number

218149

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2023-09-25

Regulatory Status

RX

2018
02 Mar
RX Application: 209753

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2018-03-02

209753 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

209753

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2018-03-02

Regulatory Status

RX

2018
02 Mar
RX Application: 209753

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2018-03-02

209753 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

209753

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2018-03-02

Regulatory Status

RX

2018
02 Mar
RX Application: 209753

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2018-03-02

209753 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

209753

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2018-03-02

Regulatory Status

RX

2002
18 Oct
OTC Application: 21472

Drug Name

MIDOL LIQUID GELS

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2002-10-18

21472 / 1

Active Ingredient

IBUPROFEN

Application Number

21472

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2002-10-18

Regulatory Status

OTC

2006
17 Feb
OTC Application: 21920

Drug Name

NAPROXEN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2006-02-17

21920 / 1

Active Ingredient

NAPROXEN SODIUM

Application Number

21920

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2006-02-17

Regulatory Status

OTC

2023
03 May
RX Application: 217555

Drug Name

NICARDIPINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2023-05-03

217555 / 1

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

217555

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2023-05-03

Regulatory Status

RX

2023
03 May
RX Application: 217555

Drug Name

NICARDIPINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2023-05-03

217555 / 2

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

217555

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2023-05-03

Regulatory Status

RX

2008
17 Jan
RX Application: 76740

Drug Name

NIMODIPINE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2008-01-17

76740 / 1

Active Ingredient

NIMODIPINE

Application Number

76740

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2008-01-17

Regulatory Status

RX

2022
04 Nov
RX Application: 209652

Drug Name

OXCARBAZEPINE

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2022-11-04

209652 / 1

Active Ingredient

OXCARBAZEPINE

Application Number

209652

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2022-11-04

Regulatory Status

RX

2019
17 Dec
RX Application: 210717

Drug Name

OXYBUTYNIN CHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-12-17

210717 / 1

Active Ingredient

OXYBUTYNIN CHLORIDE

Application Number

210717

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-12-17

Regulatory Status

RX

2019
17 Dec
RX Application: 210717

Drug Name

OXYBUTYNIN CHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-12-17

210717 / 2

Active Ingredient

OXYBUTYNIN CHLORIDE

Application Number

210717

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-12-17

Regulatory Status

RX

2019
17 Dec
RX Application: 210717

Drug Name

OXYBUTYNIN CHLORIDE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2019-12-17

210717 / 3

Active Ingredient

OXYBUTYNIN CHLORIDE

Application Number

210717

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2019-12-17

Regulatory Status

RX

2014
27 Mar
RX Application: 202539

Drug Name

PARICALCITOL

Product Number

1

Dosage Form

-

Strength

1MCG

Approval Date

2014-03-27

202539 / 1

Active Ingredient

PARICALCITOL

Application Number

202539

Product Number

1

Dosage Form

-

Strength

1MCG

Approval Date

2014-03-27

Regulatory Status

RX

2014
27 Mar
RX Application: 202539

Drug Name

PARICALCITOL

Product Number

2

Dosage Form

-

Strength

2MCG

Approval Date

2014-03-27

202539 / 2

Active Ingredient

PARICALCITOL

Application Number

202539

Product Number

2

Dosage Form

-

Strength

2MCG

Approval Date

2014-03-27

Regulatory Status

RX

2014
27 Mar
RX Application: 202539

Drug Name

PARICALCITOL

Product Number

3

Dosage Form

-

Strength

4MCG

Approval Date

2014-03-27

202539 / 3

Active Ingredient

PARICALCITOL

Application Number

202539

Product Number

3

Dosage Form

-

Strength

4MCG

Approval Date

2014-03-27

Regulatory Status

RX

2020
29 Jun
RX Application: 212799

Drug Name

POTASSIUM CITRATE

Product Number

1

Dosage Form

-

Strength

10MEQ

Approval Date

2020-06-29

212799 / 1

Active Ingredient

POTASSIUM CITRATE

Application Number

212799

Product Number

1

Dosage Form

-

Strength

10MEQ

Approval Date

2020-06-29

Regulatory Status

RX

2020
29 Jun
RX Application: 212799

Drug Name

POTASSIUM CITRATE

Product Number

2

Dosage Form

-

Strength

15MEQ

Approval Date

2020-06-29

212799 / 2

Active Ingredient

POTASSIUM CITRATE

Application Number

212799

Product Number

2

Dosage Form

-

Strength

15MEQ

Approval Date

2020-06-29

Regulatory Status

RX

2023
04 Apr
RX Application: 217478

Drug Name

PROCHLORPERAZINE MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2023-04-04

217478 / 1

Active Ingredient

PROCHLORPERAZINE MALEATE

Application Number

217478

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2023-04-04

Regulatory Status

RX

2023
04 Apr
RX Application: 217478

Drug Name

PROCHLORPERAZINE MALEATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2023-04-04

217478 / 2

Active Ingredient

PROCHLORPERAZINE MALEATE

Application Number

217478

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2023-04-04

Regulatory Status

RX

2013
16 Aug
RX Application: 200900

Drug Name

PROGESTERONE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2013-08-16

200900 / 1

Active Ingredient

PROGESTERONE

Application Number

200900

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2013-08-16

Regulatory Status

RX

2013
16 Aug
RX Application: 200900

Drug Name

PROGESTERONE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2013-08-16

200900 / 2

Active Ingredient

PROGESTERONE

Application Number

200900

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2013-08-16

Regulatory Status

RX

2019
23 Apr
RX Application: 211388

Drug Name

RUFINAMIDE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2019-04-23

211388 / 1

Active Ingredient

RUFINAMIDE

Application Number

211388

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2019-04-23

Regulatory Status

RX

2021
17 May
RX Application: 209374

Drug Name

SEVELAMER CARBONATE

Product Number

1

Dosage Form

-

Strength

800MG/PACKET

Approval Date

2021-05-17

209374 / 1

Active Ingredient

SEVELAMER CARBONATE

Application Number

209374

Product Number

1

Dosage Form

-

Strength

800MG/PACKET

Approval Date

2021-05-17

Regulatory Status

RX

2024
24 Jun
RX Application: 204135

Drug Name

SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE

Product Number

1

Dosage Form

-

Strength

1.6GM/BOT;3.13GM/BOT;17.5GM/BOT

Approval Date

2024-06-24

204135 / 1

Active Ingredient

MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

Application Number

204135

Product Number

1

Dosage Form

-

Strength

1.6GM/BOT;3.13GM/BOT;17.5GM/BOT

Approval Date

2024-06-24

Regulatory Status

RX

2008
29 Jul
Discontinued Application: 22152

Drug Name

STAVZOR

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2008-07-29

22152 / 1

Active Ingredient

VALPROIC ACID

Application Number

22152

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2008-07-29

Regulatory Status

Discontinued

2008
29 Jul
Discontinued Application: 22152

Drug Name

STAVZOR

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2008-07-29

22152 / 2

Active Ingredient

VALPROIC ACID

Application Number

22152

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2008-07-29

Regulatory Status

Discontinued

2008
29 Jul
Discontinued Application: 22152

Drug Name

STAVZOR

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2008-07-29

22152 / 3

Active Ingredient

VALPROIC ACID

Application Number

22152

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2008-07-29

Regulatory Status

Discontinued

2000
28 Jul
RX Application: 75667

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2000-07-28

75667 / 1

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

75667

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2000-07-28

Regulatory Status

RX

2000
28 Jul
RX Application: 75667

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2000-07-28

75667 / 2

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

75667

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2000-07-28

Regulatory Status

RX

2000
28 Jul
RX Application: 75667

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2000-07-28

75667 / 3

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

75667

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2000-07-28

Regulatory Status

RX

2000
28 Jul
RX Application: 75667

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2000-07-28

75667 / 4

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

75667

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2000-07-28

Regulatory Status

RX

2017
18 Dec
RX Application: 208826

Drug Name

TETRABENAZINE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2017-12-18

208826 / 1

Active Ingredient

TETRABENAZINE

Application Number

208826

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2017-12-18

Regulatory Status

RX

2017
18 Dec
RX Application: 208826

Drug Name

TETRABENAZINE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2017-12-18

208826 / 2

Active Ingredient

TETRABENAZINE

Application Number

208826

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2017-12-18

Regulatory Status

RX

2023
26 Apr
RX Application: 216300

Drug Name

THEOPHYLLINE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2023-04-26

216300 / 1

Active Ingredient

THEOPHYLLINE

Application Number

216300

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2023-04-26

Regulatory Status

RX

2023
26 Apr
RX Application: 216300

Drug Name

THEOPHYLLINE

Product Number

2

Dosage Form

-

Strength

450MG

Approval Date

2023-04-26

216300 / 2

Active Ingredient

THEOPHYLLINE

Application Number

216300

Product Number

2

Dosage Form

-

Strength

450MG

Approval Date

2023-04-26

Regulatory Status

RX

2025
19 Aug
Discontinued Application: 219123

Drug Name

TRANEXAMIC ACID

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

2025-08-19

219123 / 1

Active Ingredient

TRANEXAMIC ACID

Application Number

219123

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

2025-08-19

Regulatory Status

Discontinued

1993
29 Jun
RX Application: 73484

Drug Name

VALPROIC ACID

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1993-06-29

73484 / 1

Active Ingredient

VALPROIC ACID

Application Number

73484

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1993-06-29

Regulatory Status

RX

1982
01 Jan
RX Application: 80704

Drug Name

VITAMIN D

Product Number

1

Dosage Form

-

Strength

50,000 IU

Approval Date

1982-01-01

80704 / 1

Active Ingredient

ERGOCALCIFEROL

Application Number

80704

Product Number

1

Dosage Form

-

Strength

50,000 IU

Approval Date

1982-01-01

Regulatory Status

RX

2006
16 Aug
RX Application: 77813

Drug Name

ZONISAMIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2006-08-16

77813 / 1

Active Ingredient

ZONISAMIDE

Application Number

77813

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2006-08-16

Regulatory Status

RX

2006
16 Aug
RX Application: 77813

Drug Name

ZONISAMIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2006-08-16

77813 / 2

Active Ingredient

ZONISAMIDE

Application Number

77813

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2006-08-16

Regulatory Status

RX

2006
16 Aug
RX Application: 77813

Drug Name

ZONISAMIDE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2006-08-16

77813 / 3

Active Ingredient

ZONISAMIDE

Application Number

77813

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2006-08-16

Regulatory Status

RX

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Drug Status Breakdown
126 total
  • RX
  • OTC
  • 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

ACAMPROSATE CALCIUM

Application Number

219904

Product Number

1

Active Ingredient

ACAMPROSATE CALCIUM

Dosage Form

-

Strength

333MG

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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Searchable pharmaceutical data

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