Unichem Pharmaceuticals USA, Inc
FDA Approved Drugs

Unichem Pharmaceuticals USA, Inc

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

RX Discontinued OTC
  • Total Records 185
  • Latest Approval Date Jul 13, 2026
  • Data Source FDA
  • First Approval Date Dec 20, 2006
All
185
View
Discontinued
38
View
OTC
1
View
RX
146
View
Company Overview

Company

Unichem Pharmaceuticals USA, Inc

Country

U.S.A

Website

Visit Website

Email

Social Profiles

Company Snapshot

Unichem Pharmaceuticals USA, Inc

One Tower Center Blvd Suite 2200, East Brunswick, NJ 08816

U.S.A

www.unichemusa.com/ View on Map
FDA Approved Drug Records ( 185 records )
2016
28 Jan
RX Application: 203192

Drug Name

ALFUZOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2016-01-28

203192 / 1

Active Ingredient

ALFUZOSIN HYDROCHLORIDE

Application Number

203192

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2016-01-28

Regulatory Status

RX

2019
12 Mar
RX Application: 211820

Drug Name

ALLOPURINOL

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2019-03-12

211820 / 1

Active Ingredient

ALLOPURINOL

Application Number

211820

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2019-03-12

Regulatory Status

RX

2019
12 Mar
RX Application: 211820

Drug Name

ALLOPURINOL

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2019-03-12

211820 / 2

Active Ingredient

ALLOPURINOL

Application Number

211820

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2019-03-12

Regulatory Status

RX

2026
13 Jul
RX Application: 213204

Drug Name

ALPRAZOLAM

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2026-07-13

213204 / 1

Active Ingredient

ALPRAZOLAM

Application Number

213204

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2026-07-13

Regulatory Status

RX

2026
13 Jul
RX Application: 213204

Drug Name

ALPRAZOLAM

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2026-07-13

213204 / 2

Active Ingredient

ALPRAZOLAM

Application Number

213204

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2026-07-13

Regulatory Status

RX

2026
13 Jul
RX Application: 213204

Drug Name

ALPRAZOLAM

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2026-07-13

213204 / 3

Active Ingredient

ALPRAZOLAM

Application Number

213204

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2026-07-13

Regulatory Status

RX

2026
13 Jul
RX Application: 213204

Drug Name

ALPRAZOLAM

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2026-07-13

213204 / 4

Active Ingredient

ALPRAZOLAM

Application Number

213204

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2026-07-13

Regulatory Status

RX

2020
21 Jul
RX Application: 213446

Drug Name

AMIODARONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2020-07-21

213446 / 1

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

213446

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2020-07-21

Regulatory Status

RX

2021
19 May
RX Application: 214548

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-05-19

214548 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

214548

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-05-19

Regulatory Status

RX

2021
19 May
RX Application: 214548

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2021-05-19

214548 / 2

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

214548

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2021-05-19

Regulatory Status

RX

2021
19 May
RX Application: 214548

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2021-05-19

214548 / 3

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

214548

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2021-05-19

Regulatory Status

RX

2021
19 May
RX Application: 214548

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

2021-05-19

214548 / 4

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

214548

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

2021-05-19

Regulatory Status

RX

2021
19 May
RX Application: 214548

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

2021-05-19

214548 / 5

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

214548

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

2021-05-19

Regulatory Status

RX

2021
19 May
RX Application: 214548

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

150MG

Approval Date

2021-05-19

214548 / 6

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

214548

Product Number

6

Dosage Form

-

Strength

150MG

Approval Date

2021-05-19

Regulatory Status

RX

2013
21 Oct
RX Application: 203245

Drug Name

AMLODIPINE BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2013-10-21

203245 / 1

Active Ingredient

AMLODIPINE BESYLATE

Application Number

203245

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2013-10-21

Regulatory Status

RX

2013
21 Oct
RX Application: 203245

Drug Name

AMLODIPINE BESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2013-10-21

203245 / 2

Active Ingredient

AMLODIPINE BESYLATE

Application Number

203245

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2013-10-21

Regulatory Status

RX

2013
21 Oct
RX Application: 203245

Drug Name

AMLODIPINE BESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2013-10-21

203245 / 3

Active Ingredient

AMLODIPINE BESYLATE

Application Number

203245

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2013-10-21

Regulatory Status

RX

2021
17 Feb
Discontinued Application: 211819

Drug Name

APREMILAST

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-02-17

211819 / 1

Active Ingredient

APREMILAST

Application Number

211819

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-02-17

Regulatory Status

Discontinued

2021
17 Feb
Discontinued Application: 211819

Drug Name

APREMILAST

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2021-02-17

211819 / 2

Active Ingredient

APREMILAST

Application Number

211819

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2021-02-17

Regulatory Status

Discontinued

2021
17 Feb
Discontinued Application: 211819

Drug Name

APREMILAST

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2021-02-17

211819 / 3

Active Ingredient

APREMILAST

Application Number

211819

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2021-02-17

Regulatory Status

Discontinued

2021
01 Dec
RX Application: 203025

Drug Name

ARIPIPRAZOLE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2021-12-01

203025 / 1

Active Ingredient

ARIPIPRAZOLE

Application Number

203025

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2021-12-01

Regulatory Status

RX

2021
01 Dec
RX Application: 203025

Drug Name

ARIPIPRAZOLE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2021-12-01

203025 / 2

Active Ingredient

ARIPIPRAZOLE

Application Number

203025

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2021-12-01

Regulatory Status

RX

2021
01 Dec
RX Application: 203025

Drug Name

ARIPIPRAZOLE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2021-12-01

203025 / 3

Active Ingredient

ARIPIPRAZOLE

Application Number

203025

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2021-12-01

Regulatory Status

RX

2021
01 Dec
RX Application: 203025

Drug Name

ARIPIPRAZOLE

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2021-12-01

203025 / 4

Active Ingredient

ARIPIPRAZOLE

Application Number

203025

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2021-12-01

Regulatory Status

RX

2021
01 Dec
RX Application: 203025

Drug Name

ARIPIPRAZOLE

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2021-12-01

203025 / 5

Active Ingredient

ARIPIPRAZOLE

Application Number

203025

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2021-12-01

Regulatory Status

RX

2021
01 Dec
RX Application: 203025

Drug Name

ARIPIPRAZOLE

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2021-12-01

203025 / 6

Active Ingredient

ARIPIPRAZOLE

Application Number

203025

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2021-12-01

Regulatory Status

RX

2019
21 Nov
RX Application: 213136

Drug Name

ATENOLOL

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-11-21

213136 / 1

Active Ingredient

ATENOLOL

Application Number

213136

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-11-21

Regulatory Status

RX

2019
21 Nov
RX Application: 213136

Drug Name

ATENOLOL

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2019-11-21

213136 / 2

Active Ingredient

ATENOLOL

Application Number

213136

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2019-11-21

Regulatory Status

RX

2019
21 Nov
RX Application: 213136

Drug Name

ATENOLOL

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2019-11-21

213136 / 3

Active Ingredient

ATENOLOL

Application Number

213136

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2019-11-21

Regulatory Status

RX

2020
25 Nov
RX Application: 213302

Drug Name

ATENOLOL AND CHLORTHALIDONE

Product Number

1

Dosage Form

-

Strength

50MG;25MG

Approval Date

2020-11-25

213302 / 1

Active Ingredient

ATENOLOL; CHLORTHALIDONE

Application Number

213302

Product Number

1

Dosage Form

-

Strength

50MG;25MG

Approval Date

2020-11-25

Regulatory Status

RX

2020
25 Nov
RX Application: 213302

Drug Name

ATENOLOL AND CHLORTHALIDONE

Product Number

2

Dosage Form

-

Strength

100MG;25MG

Approval Date

2020-11-25

213302 / 2

Active Ingredient

ATENOLOL; CHLORTHALIDONE

Application Number

213302

Product Number

2

Dosage Form

-

Strength

100MG;25MG

Approval Date

2020-11-25

Regulatory Status

RX

2020
09 Jul
RX Application: 212067

Drug Name

BACLOFEN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2020-07-09

212067 / 1

Active Ingredient

BACLOFEN

Application Number

212067

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2020-07-09

Regulatory Status

RX

2020
09 Jul
RX Application: 212067

Drug Name

BACLOFEN

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2020-07-09

212067 / 2

Active Ingredient

BACLOFEN

Application Number

212067

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2020-07-09

Regulatory Status

RX

2023
09 Mar
RX Application: 212067

Drug Name

BACLOFEN

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2023-03-09

212067 / 3

Active Ingredient

BACLOFEN

Application Number

212067

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2023-03-09

Regulatory Status

RX

2009
18 Aug
RX Application: 78635

Drug Name

BISOPROLOL FUMARATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-08-18

78635 / 1

Active Ingredient

BISOPROLOL FUMARATE

Application Number

78635

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-08-18

Regulatory Status

RX

2009
18 Aug
RX Application: 78635

Drug Name

BISOPROLOL FUMARATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2009-08-18

78635 / 2

Active Ingredient

BISOPROLOL FUMARATE

Application Number

78635

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2009-08-18

Regulatory Status

RX

2010
28 Jul
RX Application: 79106

Drug Name

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

2.5MG;6.25MG

Approval Date

2010-07-28

79106 / 1

Active Ingredient

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Application Number

79106

Product Number

1

Dosage Form

-

Strength

2.5MG;6.25MG

Approval Date

2010-07-28

Regulatory Status

RX

2010
28 Jul
RX Application: 79106

Drug Name

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2010-07-28

79106 / 2

Active Ingredient

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Application Number

79106

Product Number

2

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2010-07-28

Regulatory Status

RX

2010
28 Jul
RX Application: 79106

Drug Name

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

10MG;6.25MG

Approval Date

2010-07-28

79106 / 3

Active Ingredient

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Application Number

79106

Product Number

3

Dosage Form

-

Strength

10MG;6.25MG

Approval Date

2010-07-28

Regulatory Status

RX

2019
14 Nov
RX Application: 210907

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-11-14

210907 / 1

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

210907

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-11-14

Regulatory Status

RX

2019
14 Nov
RX Application: 210907

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-11-14

210907 / 2

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

210907

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-11-14

Regulatory Status

RX

2019
14 Nov
RX Application: 210907

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2019-11-14

210907 / 3

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

210907

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2019-11-14

Regulatory Status

RX

2019
14 Nov
RX Application: 210907

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2019-11-14

210907 / 4

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

210907

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2019-11-14

Regulatory Status

RX

2022
22 Aug
RX Application: 213284

Drug Name

CARBAMAZEPINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2022-08-22

213284 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

213284

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2022-08-22

Regulatory Status

RX

2021
12 Jan
Discontinued Application: 213301

Drug Name

CELECOXIB

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2021-01-12

213301 / 1

Active Ingredient

CELECOXIB

Application Number

213301

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2021-01-12

Regulatory Status

Discontinued

2021
12 Jan
Discontinued Application: 213301

Drug Name

CELECOXIB

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2021-01-12

213301 / 2

Active Ingredient

CELECOXIB

Application Number

213301

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2021-01-12

Regulatory Status

Discontinued

2021
12 Jan
Discontinued Application: 213301

Drug Name

CELECOXIB

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2021-01-12

213301 / 3

Active Ingredient

CELECOXIB

Application Number

213301

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2021-01-12

Regulatory Status

Discontinued

2021
12 Jan
Discontinued Application: 213301

Drug Name

CELECOXIB

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

2021-01-12

213301 / 4

Active Ingredient

CELECOXIB

Application Number

213301

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

2021-01-12

Regulatory Status

Discontinued

2009
26 Jun
Discontinued Application: 78680

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2009-06-26

78680 / 3

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

78680

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2009-06-26

Regulatory Status

Discontinued

2009
26 Jun
Discontinued Application: 78680

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2009-06-26

78680 / 4

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

78680

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2009-06-26

Regulatory Status

Discontinued

2024
10 Sep
Discontinued Application: 210507

Drug Name

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG;120MG

Approval Date

2024-09-10

210507 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

210507

Product Number

1

Dosage Form

-

Strength

5MG;120MG

Approval Date

2024-09-10

Regulatory Status

Discontinued

2009
26 Jun
Discontinued Application: 78680

Drug Name

CETIRIZINE HYDROCHLORIDE HIVES

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-06-26

78680 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

78680

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-06-26

Regulatory Status

Discontinued

2009
26 Jun
Discontinued Application: 78680

Drug Name

CETIRIZINE HYDROCHLORIDE HIVES

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2009-06-26

78680 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

78680

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2009-06-26

Regulatory Status

Discontinued

2019
06 Aug
RX Application: 211627

Drug Name

CHLORTHALIDONE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-08-06

211627 / 1

Active Ingredient

CHLORTHALIDONE

Application Number

211627

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-08-06

Regulatory Status

RX

2019
06 Aug
RX Application: 211627

Drug Name

CHLORTHALIDONE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2019-08-06

211627 / 2

Active Ingredient

CHLORTHALIDONE

Application Number

211627

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2019-08-06

Regulatory Status

RX

2009
26 Aug
RX Application: 78895

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2009-08-26

78895 / 1

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

78895

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2009-08-26

Regulatory Status

RX

2009
26 Aug
RX Application: 78895

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2009-08-26

78895 / 2

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

78895

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2009-08-26

Regulatory Status

RX

2009
26 Aug
RX Application: 78895

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

0.3MG

Approval Date

2009-08-26

78895 / 3

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

78895

Product Number

3

Dosage Form

-

Strength

0.3MG

Approval Date

2009-08-26

Regulatory Status

RX

2020
06 Jul
RX Application: 213324

Drug Name

CYCLOBENZAPRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2020-07-06

213324 / 1

Active Ingredient

CYCLOBENZAPRINE HYDROCHLORIDE

Application Number

213324

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2020-07-06

Regulatory Status

RX

2020
06 Jul
RX Application: 213324

Drug Name

CYCLOBENZAPRINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2020-07-06

213324 / 2

Active Ingredient

CYCLOBENZAPRINE HYDROCHLORIDE

Application Number

213324

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2020-07-06

Regulatory Status

RX

2020
05 Jul
RX Application: 213324

Drug Name

CYCLOBENZAPRINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2020-07-05

213324 / 3

Active Ingredient

CYCLOBENZAPRINE HYDROCHLORIDE

Application Number

213324

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2020-07-05

Regulatory Status

RX

2018
13 Nov
RX Application: 210819

Drug Name

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Product Number

1

Dosage Form

-

Strength

0.025MG;2.5MG

Approval Date

2018-11-13

210819 / 1

Active Ingredient

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

Application Number

210819

Product Number

1

Dosage Form

-

Strength

0.025MG;2.5MG

Approval Date

2018-11-13

Regulatory Status

RX

2022
25 Feb
RX Application: 214643

Drug Name

DIVALPROEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2022-02-25

214643 / 1

Active Ingredient

DIVALPROEX SODIUM

Application Number

214643

Product Number

1

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2022-02-25

Regulatory Status

RX

2022
25 Feb
RX Application: 214643

Drug Name

DIVALPROEX SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2022-02-25

214643 / 2

Active Ingredient

DIVALPROEX SODIUM

Application Number

214643

Product Number

2

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2022-02-25

Regulatory Status

RX

2016
23 Jun
Discontinued Application: 203656

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2016-06-23

203656 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

203656

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2016-06-23

Regulatory Status

Discontinued

2016
23 Jun
Discontinued Application: 203656

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2016-06-23

203656 / 2

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

203656

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2016-06-23

Regulatory Status

Discontinued

2016
10 Nov
Discontinued Application: 204831

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2016-11-10

204831 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

204831

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2016-11-10

Regulatory Status

Discontinued

2016
10 Nov
Discontinued Application: 204831

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2016-11-10

204831 / 2

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

204831

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2016-11-10

Regulatory Status

Discontinued

2024
10 Jan
RX Application: 212329

Drug Name

DOXAZOSIN MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2024-01-10

212329 / 1

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

212329

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2024-01-10

Regulatory Status

RX

2024
10 Jan
RX Application: 212329

Drug Name

DOXAZOSIN MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2024-01-10

212329 / 2

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

212329

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2024-01-10

Regulatory Status

RX

2024
10 Jan
RX Application: 212329

Drug Name

DOXAZOSIN MESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2024-01-10

212329 / 3

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

212329

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2024-01-10

Regulatory Status

RX

2024
10 Jan
RX Application: 212329

Drug Name

DOXAZOSIN MESYLATE

Product Number

4

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2024-01-10

212329 / 4

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

212329

Product Number

4

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2024-01-10

Regulatory Status

RX

2020
24 Nov
RX Application: 212263

Drug Name

ETODOLAC

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2020-11-24

212263 / 1

Active Ingredient

ETODOLAC

Application Number

212263

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2020-11-24

Regulatory Status

RX

2020
24 Nov
RX Application: 212263

Drug Name

ETODOLAC

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2020-11-24

212263 / 2

Active Ingredient

ETODOLAC

Application Number

212263

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2020-11-24

Regulatory Status

RX

2020
24 Nov
RX Application: 212263

Drug Name

ETODOLAC

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2020-11-24

212263 / 3

Active Ingredient

ETODOLAC

Application Number

212263

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2020-11-24

Regulatory Status

RX

2022
13 Oct
Discontinued Application: 213834

Drug Name

EXTENDED PHENYTOIN SODIUM

Product Number

1

Dosage Form

-

Strength

100MG EXTENDED

Approval Date

2022-10-13

213834 / 1

Active Ingredient

PHENYTOIN SODIUM

Application Number

213834

Product Number

1

Dosage Form

-

Strength

100MG EXTENDED

Approval Date

2022-10-13

Regulatory Status

Discontinued

2024
16 Jan
RX Application: 217605

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

2024-01-16

217605 / 1

Active Ingredient

FAMOTIDINE

Application Number

217605

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

2024-01-16

Regulatory Status

RX

2021
03 Mar
RX Application: 214689

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2021-03-03

214689 / 1

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

214689

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2021-03-03

Regulatory Status

RX

2021
03 Mar
RX Application: 214689

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2021-03-03

214689 / 2

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

214689

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2021-03-03

Regulatory Status

RX

2024
19 Nov
RX Application: 219033

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2024-11-19

219033 / 1

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

219033

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2024-11-19

Regulatory Status

RX

2024
19 Nov
RX Application: 219033

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2024-11-19

219033 / 2

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

219033

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2024-11-19

Regulatory Status

RX

2024
19 Nov
RX Application: 219033

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2024-11-19

219033 / 3

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

219033

Product Number

3

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2024-11-19

Regulatory Status

RX

2024
19 Nov
RX Application: 219033

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2024-11-19

219033 / 4

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

219033

Product Number

4

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2024-11-19

Regulatory Status

RX

2008
15 Aug
RX Application: 40907

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2008-08-15

40907 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

40907

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2008-08-15

Regulatory Status

RX

2008
15 Aug
RX Application: 40907

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2008-08-15

40907 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

40907

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2008-08-15

Regulatory Status

RX

2025
03 Apr
RX Application: 40907

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2025-04-03

40907 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

40907

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2025-04-03

Regulatory Status

RX

2010
19 Jan
RX Application: 90510

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2010-01-19

90510 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

90510

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2010-01-19

Regulatory Status

RX

2015
07 Dec
RX Application: 203020

Drug Name

IRBESARTAN

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2015-12-07

203020 / 1

Active Ingredient

IRBESARTAN

Application Number

203020

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2015-12-07

Regulatory Status

RX

2015
07 Dec
RX Application: 203020

Drug Name

IRBESARTAN

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2015-12-07

203020 / 2

Active Ingredient

IRBESARTAN

Application Number

203020

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2015-12-07

Regulatory Status

RX

2015
07 Dec
RX Application: 203020

Drug Name

IRBESARTAN

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2015-12-07

203020 / 3

Active Ingredient

IRBESARTAN

Application Number

203020

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2015-12-07

Regulatory Status

RX

2017
19 Sep
Discontinued Application: 207018

Drug Name

IRBESARTAN AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;150MG

Approval Date

2017-09-19

207018 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; IRBESARTAN

Application Number

207018

Product Number

1

Dosage Form

-

Strength

12.5MG;150MG

Approval Date

2017-09-19

Regulatory Status

Discontinued

2017
19 Sep
Discontinued Application: 207018

Drug Name

IRBESARTAN AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;300MG

Approval Date

2017-09-19

207018 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; IRBESARTAN

Application Number

207018

Product Number

2

Dosage Form

-

Strength

12.5MG;300MG

Approval Date

2017-09-19

Regulatory Status

Discontinued

2020
01 Jun
OTC Application: 204059

Drug Name

KETOTIFEN FUMARATE

Product Number

1

Dosage Form

-

Strength

EQ 0.025% BASE

Approval Date

2020-06-01

204059 / 1

Active Ingredient

KETOTIFEN FUMARATE

Application Number

204059

Product Number

1

Dosage Form

-

Strength

EQ 0.025% BASE

Approval Date

2020-06-01

Regulatory Status

OTC

2022
08 Aug
Discontinued Application: 212719

Drug Name

LABETALOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2022-08-08

212719 / 1

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

212719

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2022-08-08

Regulatory Status

Discontinued

2022
08 Aug
Discontinued Application: 212719

Drug Name

LABETALOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2022-08-08

212719 / 2

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

212719

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2022-08-08

Regulatory Status

Discontinued

2022
08 Aug
Discontinued Application: 212719

Drug Name

LABETALOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2022-08-08

212719 / 3

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

212719

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2022-08-08

Regulatory Status

Discontinued

2024
04 Sep
RX Application: 213109

Drug Name

LACOSAMIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2024-09-04

213109 / 1

Active Ingredient

LACOSAMIDE

Application Number

213109

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2024-09-04

Regulatory Status

RX

2024
04 Sep
RX Application: 213109

Drug Name

LACOSAMIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2024-09-04

213109 / 2

Active Ingredient

LACOSAMIDE

Application Number

213109

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2024-09-04

Regulatory Status

RX

2024
04 Sep
RX Application: 213109

Drug Name

LACOSAMIDE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2024-09-04

213109 / 3

Active Ingredient

LACOSAMIDE

Application Number

213109

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2024-09-04

Regulatory Status

RX

2024
04 Sep
RX Application: 213109

Drug Name

LACOSAMIDE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2024-09-04

213109 / 4

Active Ingredient

LACOSAMIDE

Application Number

213109

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2024-09-04

Regulatory Status

RX

2015
14 Oct
RX Application: 203030

Drug Name

LOSARTAN POTASSIUM

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2015-10-14

203030 / 1

Active Ingredient

LOSARTAN POTASSIUM

Application Number

203030

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2015-10-14

Regulatory Status

RX

2015
14 Oct
RX Application: 203030

Drug Name

LOSARTAN POTASSIUM

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2015-10-14

203030 / 2

Active Ingredient

LOSARTAN POTASSIUM

Application Number

203030

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2015-10-14

Regulatory Status

RX

2015
14 Oct
RX Application: 203030

Drug Name

LOSARTAN POTASSIUM

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2015-10-14

203030 / 3

Active Ingredient

LOSARTAN POTASSIUM

Application Number

203030

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2015-10-14

Regulatory Status

RX

2017
21 Jul
RX Application: 204832

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;50MG

Approval Date

2017-07-21

204832 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

204832

Product Number

1

Dosage Form

-

Strength

12.5MG;50MG

Approval Date

2017-07-21

Regulatory Status

RX

2017
21 Jul
RX Application: 204832

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;100MG

Approval Date

2017-07-21

204832 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

204832

Product Number

2

Dosage Form

-

Strength

12.5MG;100MG

Approval Date

2017-07-21

Regulatory Status

RX

2017
21 Jul
RX Application: 204832

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;100MG

Approval Date

2017-07-21

204832 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

204832

Product Number

3

Dosage Form

-

Strength

25MG;100MG

Approval Date

2017-07-21

Regulatory Status

RX

2006
20 Dec
RX Application: 77927

Drug Name

MELOXICAM

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2006-12-20

77927 / 1

Active Ingredient

MELOXICAM

Application Number

77927

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2006-12-20

Regulatory Status

RX

2006
20 Dec
RX Application: 77927

Drug Name

MELOXICAM

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2006-12-20

77927 / 2

Active Ingredient

MELOXICAM

Application Number

77927

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2006-12-20

Regulatory Status

RX

2015
13 Oct
RX Application: 200022

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-10-13

200022 / 1

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

200022

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-10-13

Regulatory Status

RX

2015
13 Oct
RX Application: 200022

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-10-13

200022 / 2

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

200022

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-10-13

Regulatory Status

RX

2021
11 Aug
RX Application: 213359

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2021-08-11

213359 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

213359

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2021-08-11

Regulatory Status

RX

2021
11 Aug
RX Application: 213359

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2021-08-11

213359 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

213359

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2021-08-11

Regulatory Status

RX

2012
24 Sep
RX Application: 200602

Drug Name

METHSCOPOLAMINE BROMIDE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2012-09-24

200602 / 1

Active Ingredient

METHSCOPOLAMINE BROMIDE

Application Number

200602

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2012-09-24

Regulatory Status

RX

2012
24 Sep
RX Application: 200602

Drug Name

METHSCOPOLAMINE BROMIDE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2012-09-24

200602 / 2

Active Ingredient

METHSCOPOLAMINE BROMIDE

Application Number

200602

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2012-09-24

Regulatory Status

RX

2021
30 Mar
RX Application: 214799

Drug Name

METOLAZONE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2021-03-30

214799 / 1

Active Ingredient

METOLAZONE

Application Number

214799

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2021-03-30

Regulatory Status

RX

2021
30 Mar
RX Application: 214799

Drug Name

METOLAZONE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2021-03-30

214799 / 2

Active Ingredient

METOLAZONE

Application Number

214799

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2021-03-30

Regulatory Status

RX

2021
30 Mar
RX Application: 214799

Drug Name

METOLAZONE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2021-03-30

214799 / 3

Active Ingredient

METOLAZONE

Application Number

214799

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2021-03-30

Regulatory Status

RX

2014
22 Jan
RX Application: 203458

Drug Name

METRONIDAZOLE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2014-01-22

203458 / 1

Active Ingredient

METRONIDAZOLE

Application Number

203458

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2014-01-22

Regulatory Status

RX

2014
22 Jan
RX Application: 203458

Drug Name

METRONIDAZOLE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2014-01-22

203458 / 2

Active Ingredient

METRONIDAZOLE

Application Number

203458

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2014-01-22

Regulatory Status

RX

2015
08 Oct
RX Application: 204290

Drug Name

MONTELUKAST SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2015-10-08

204290 / 1

Active Ingredient

MONTELUKAST SODIUM

Application Number

204290

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2015-10-08

Regulatory Status

RX

2018
02 Jul
RX Application: 208621

Drug Name

MONTELUKAST SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2018-07-02

208621 / 1

Active Ingredient

MONTELUKAST SODIUM

Application Number

208621

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2018-07-02

Regulatory Status

RX

2018
02 Jul
RX Application: 208621

Drug Name

MONTELUKAST SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2018-07-02

208621 / 2

Active Ingredient

MONTELUKAST SODIUM

Application Number

208621

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2018-07-02

Regulatory Status

RX

2022
15 Mar
RX Application: 213830

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2022-03-15

213830 / 1

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

213830

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2022-03-15

Regulatory Status

RX

2022
15 Mar
RX Application: 213830

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2022-03-15

213830 / 2

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

213830

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2022-03-15

Regulatory Status

RX

2022
15 Mar
RX Application: 213830

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2022-03-15

213830 / 3

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

213830

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2022-03-15

Regulatory Status

RX

2022
15 Mar
RX Application: 213830

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2022-03-15

213830 / 4

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

213830

Product Number

4

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2022-03-15

Regulatory Status

RX

2012
27 Jul
RX Application: 91158

Drug Name

ORPHENADRINE CITRATE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2012-07-27

91158 / 1

Active Ingredient

ORPHENADRINE CITRATE

Application Number

91158

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2012-07-27

Regulatory Status

RX

2019
01 Aug
RX Application: 211712

Drug Name

PINDOLOL

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-08-01

211712 / 1

Active Ingredient

PINDOLOL

Application Number

211712

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-08-01

Regulatory Status

RX

2019
01 Aug
RX Application: 211712

Drug Name

PINDOLOL

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-08-01

211712 / 2

Active Ingredient

PINDOLOL

Application Number

211712

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-08-01

Regulatory Status

RX

2017
13 Apr
Discontinued Application: 208340

Drug Name

PIROXICAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-04-13

208340 / 1

Active Ingredient

PIROXICAM

Application Number

208340

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-04-13

Regulatory Status

Discontinued

2017
13 Apr
Discontinued Application: 208340

Drug Name

PIROXICAM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2017-04-13

208340 / 2

Active Ingredient

PIROXICAM

Application Number

208340

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2017-04-13

Regulatory Status

Discontinued

2018
19 Dec
Discontinued Application: 207011

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2018-12-19

207011 / 1

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

207011

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2018-12-19

Regulatory Status

Discontinued

2018
19 Dec
Discontinued Application: 207011

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2018-12-19

207011 / 2

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

207011

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2018-12-19

Regulatory Status

Discontinued

2018
19 Dec
Discontinued Application: 207011

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2018-12-19

207011 / 3

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

207011

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2018-12-19

Regulatory Status

Discontinued

2018
19 Dec
Discontinued Application: 207011

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

0.75MG

Approval Date

2018-12-19

207011 / 4

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

207011

Product Number

4

Dosage Form

-

Strength

0.75MG

Approval Date

2018-12-19

Regulatory Status

Discontinued

2018
19 Dec
Discontinued Application: 207011

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

1MG

Approval Date

2018-12-19

207011 / 5

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

207011

Product Number

5

Dosage Form

-

Strength

1MG

Approval Date

2018-12-19

Regulatory Status

Discontinued

2018
19 Dec
Discontinued Application: 207011

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

1.5MG

Approval Date

2018-12-19

207011 / 6

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

207011

Product Number

6

Dosage Form

-

Strength

1.5MG

Approval Date

2018-12-19

Regulatory Status

Discontinued

2023
28 Aug
RX Application: 213315

Drug Name

PRASUGREL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2023-08-28

213315 / 1

Active Ingredient

PRASUGREL HYDROCHLORIDE

Application Number

213315

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2023-08-28

Regulatory Status

RX

2023
28 Aug
RX Application: 213315

Drug Name

PRASUGREL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2023-08-28

213315 / 2

Active Ingredient

PRASUGREL HYDROCHLORIDE

Application Number

213315

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2023-08-28

Regulatory Status

RX

2026
30 Apr
RX Application: 219593

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2026-04-30

219593 / 1

Active Ingredient

PREGABALIN

Application Number

219593

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2026-04-30

Regulatory Status

RX

2026
30 Apr
RX Application: 219593

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2026-04-30

219593 / 2

Active Ingredient

PREGABALIN

Application Number

219593

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2026-04-30

Regulatory Status

RX

2026
30 Apr
RX Application: 219593

Drug Name

PREGABALIN

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2026-04-30

219593 / 3

Active Ingredient

PREGABALIN

Application Number

219593

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2026-04-30

Regulatory Status

RX

2026
30 Apr
RX Application: 219593

Drug Name

PREGABALIN

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2026-04-30

219593 / 4

Active Ingredient

PREGABALIN

Application Number

219593

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2026-04-30

Regulatory Status

RX

2026
30 Apr
RX Application: 219593

Drug Name

PREGABALIN

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2026-04-30

219593 / 5

Active Ingredient

PREGABALIN

Application Number

219593

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2026-04-30

Regulatory Status

RX

2026
30 Apr
RX Application: 219593

Drug Name

PREGABALIN

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2026-04-30

219593 / 6

Active Ingredient

PREGABALIN

Application Number

219593

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2026-04-30

Regulatory Status

RX

2026
30 Apr
RX Application: 219593

Drug Name

PREGABALIN

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2026-04-30

219593 / 7

Active Ingredient

PREGABALIN

Application Number

219593

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2026-04-30

Regulatory Status

RX

2026
30 Apr
RX Application: 219593

Drug Name

PREGABALIN

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2026-04-30

219593 / 8

Active Ingredient

PREGABALIN

Application Number

219593

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2026-04-30

Regulatory Status

RX

2014
25 Feb
RX Application: 204476

Drug Name

PRIMAQUINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2014-02-25

204476 / 1

Active Ingredient

PRIMAQUINE PHOSPHATE

Application Number

204476

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2014-02-25

Regulatory Status

RX

2016
08 Mar
RX Application: 202674

Drug Name

QUETIAPINE FUMARATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2016-03-08

202674 / 1

Active Ingredient

QUETIAPINE FUMARATE

Application Number

202674

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2016-03-08

Regulatory Status

RX

2016
08 Mar
RX Application: 202674

Drug Name

QUETIAPINE FUMARATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2016-03-08

202674 / 2

Active Ingredient

QUETIAPINE FUMARATE

Application Number

202674

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2016-03-08

Regulatory Status

RX

2016
08 Mar
RX Application: 202674

Drug Name

QUETIAPINE FUMARATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2016-03-08

202674 / 3

Active Ingredient

QUETIAPINE FUMARATE

Application Number

202674

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2016-03-08

Regulatory Status

RX

2016
08 Mar
RX Application: 202674

Drug Name

QUETIAPINE FUMARATE

Product Number

4

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2016-03-08

202674 / 4

Active Ingredient

QUETIAPINE FUMARATE

Application Number

202674

Product Number

4

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2016-03-08

Regulatory Status

RX

2016
08 Mar
RX Application: 202674

Drug Name

QUETIAPINE FUMARATE

Product Number

5

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2016-03-08

202674 / 5

Active Ingredient

QUETIAPINE FUMARATE

Application Number

202674

Product Number

5

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2016-03-08

Regulatory Status

RX

2016
08 Mar
RX Application: 202674

Drug Name

QUETIAPINE FUMARATE

Product Number

6

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2016-03-08

202674 / 6

Active Ingredient

QUETIAPINE FUMARATE

Application Number

202674

Product Number

6

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2016-03-08

Regulatory Status

RX

2022
15 Aug
RX Application: 215478

Drug Name

QUETIAPINE FUMARATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2022-08-15

215478 / 1

Active Ingredient

QUETIAPINE FUMARATE

Application Number

215478

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2022-08-15

Regulatory Status

RX

2022
15 Aug
RX Application: 215478

Drug Name

QUETIAPINE FUMARATE

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2022-08-15

215478 / 2

Active Ingredient

QUETIAPINE FUMARATE

Application Number

215478

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2022-08-15

Regulatory Status

RX

2022
15 Aug
RX Application: 215478

Drug Name

QUETIAPINE FUMARATE

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2022-08-15

215478 / 3

Active Ingredient

QUETIAPINE FUMARATE

Application Number

215478

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2022-08-15

Regulatory Status

RX

2022
15 Aug
RX Application: 215478

Drug Name

QUETIAPINE FUMARATE

Product Number

4

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2022-08-15

215478 / 4

Active Ingredient

QUETIAPINE FUMARATE

Application Number

215478

Product Number

4

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2022-08-15

Regulatory Status

RX

2022
15 Aug
RX Application: 215478

Drug Name

QUETIAPINE FUMARATE

Product Number

5

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2022-08-15

215478 / 5

Active Ingredient

QUETIAPINE FUMARATE

Application Number

215478

Product Number

5

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2022-08-15

Regulatory Status

RX

2023
16 Mar
RX Application: 213083

Drug Name

RANOLAZINE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2023-03-16

213083 / 1

Active Ingredient

RANOLAZINE

Application Number

213083

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2023-03-16

Regulatory Status

RX

2023
16 Mar
RX Application: 213083

Drug Name

RANOLAZINE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2023-03-16

213083 / 2

Active Ingredient

RANOLAZINE

Application Number

213083

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2023-03-16

Regulatory Status

RX

2017
07 Mar
Discontinued Application: 207835

Drug Name

RIZATRIPTAN BENZOATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2017-03-07

207835 / 1

Active Ingredient

RIZATRIPTAN BENZOATE

Application Number

207835

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2017-03-07

Regulatory Status

Discontinued

2017
07 Mar
Discontinued Application: 207835

Drug Name

RIZATRIPTAN BENZOATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2017-03-07

207835 / 2

Active Ingredient

RIZATRIPTAN BENZOATE

Application Number

207835

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2017-03-07

Regulatory Status

Discontinued

2017
07 Mar
Discontinued Application: 207836

Drug Name

RIZATRIPTAN BENZOATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2017-03-07

207836 / 1

Active Ingredient

RIZATRIPTAN BENZOATE

Application Number

207836

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2017-03-07

Regulatory Status

Discontinued

2017
07 Mar
Discontinued Application: 207836

Drug Name

RIZATRIPTAN BENZOATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2017-03-07

207836 / 2

Active Ingredient

RIZATRIPTAN BENZOATE

Application Number

207836

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2017-03-07

Regulatory Status

Discontinued

2019
27 Aug
RX Application: 211701

Drug Name

SOLIFENACIN SUCCINATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-08-27

211701 / 1

Active Ingredient

SOLIFENACIN SUCCINATE

Application Number

211701

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-08-27

Regulatory Status

RX

2019
27 Aug
RX Application: 211701

Drug Name

SOLIFENACIN SUCCINATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-08-27

211701 / 2

Active Ingredient

SOLIFENACIN SUCCINATE

Application Number

211701

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-08-27

Regulatory Status

RX

2019
26 Mar
RX Application: 209250

Drug Name

TADALAFIL

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2019-03-26

209250 / 1

Active Ingredient

TADALAFIL

Application Number

209250

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2019-03-26

Regulatory Status

RX

2019
26 Mar
RX Application: 209250

Drug Name

TADALAFIL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-03-26

209250 / 2

Active Ingredient

TADALAFIL

Application Number

209250

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-03-26

Regulatory Status

RX

2019
26 Mar
RX Application: 209250

Drug Name

TADALAFIL

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2019-03-26

209250 / 3

Active Ingredient

TADALAFIL

Application Number

209250

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2019-03-26

Regulatory Status

RX

2019
26 Mar
RX Application: 209250

Drug Name

TADALAFIL

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2019-03-26

209250 / 4

Active Ingredient

TADALAFIL

Application Number

209250

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2019-03-26

Regulatory Status

RX

2020
05 Aug
RX Application: 205399

Drug Name

TOLTERODINE TARTRATE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2020-08-05

205399 / 1

Active Ingredient

TOLTERODINE TARTRATE

Application Number

205399

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2020-08-05

Regulatory Status

RX

2020
05 Aug
RX Application: 205399

Drug Name

TOLTERODINE TARTRATE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2020-08-05

205399 / 2

Active Ingredient

TOLTERODINE TARTRATE

Application Number

205399

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2020-08-05

Regulatory Status

RX

2024
27 Aug
RX Application: 216917

Drug Name

TOLTERODINE TARTRATE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2024-08-27

216917 / 1

Active Ingredient

TOLTERODINE TARTRATE

Application Number

216917

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2024-08-27

Regulatory Status

RX

2024
27 Aug
RX Application: 216917

Drug Name

TOLTERODINE TARTRATE

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2024-08-27

216917 / 2

Active Ingredient

TOLTERODINE TARTRATE

Application Number

216917

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2024-08-27

Regulatory Status

RX

2019
09 Aug
RX Application: 211825

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2019-08-09

211825 / 1

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

211825

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2019-08-09

Regulatory Status

RX

2018
04 May
Discontinued Application: 209261

Drug Name

VALSARTAN

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2018-05-04

209261 / 1

Active Ingredient

VALSARTAN

Application Number

209261

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2018-05-04

Regulatory Status

Discontinued

2018
04 May
Discontinued Application: 209261

Drug Name

VALSARTAN

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2018-05-04

209261 / 2

Active Ingredient

VALSARTAN

Application Number

209261

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2018-05-04

Regulatory Status

Discontinued

2018
04 May
Discontinued Application: 209261

Drug Name

VALSARTAN

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2018-05-04

209261 / 3

Active Ingredient

VALSARTAN

Application Number

209261

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2018-05-04

Regulatory Status

Discontinued

2018
04 May
Discontinued Application: 209261

Drug Name

VALSARTAN

Product Number

4

Dosage Form

-

Strength

320MG

Approval Date

2018-05-04

209261 / 4

Active Ingredient

VALSARTAN

Application Number

209261

Product Number

4

Dosage Form

-

Strength

320MG

Approval Date

2018-05-04

Regulatory Status

Discontinued

2008
06 Jun
RX Application: 78989

Drug Name

ZALEPLON

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-06-06

78989 / 1

Active Ingredient

ZALEPLON

Application Number

78989

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-06-06

Regulatory Status

RX

2008
06 Jun
RX Application: 78989

Drug Name

ZALEPLON

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-06-06

78989 / 2

Active Ingredient

ZALEPLON

Application Number

78989

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-06-06

Regulatory Status

RX

2021
26 Jan
RX Application: 214492

Drug Name

ZONISAMIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2021-01-26

214492 / 1

Active Ingredient

ZONISAMIDE

Application Number

214492

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2021-01-26

Regulatory Status

RX

2021
26 Jan
RX Application: 214492

Drug Name

ZONISAMIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2021-01-26

214492 / 2

Active Ingredient

ZONISAMIDE

Application Number

214492

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2021-01-26

Regulatory Status

RX

2021
26 Jan
RX Application: 214492

Drug Name

ZONISAMIDE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2021-01-26

214492 / 3

Active Ingredient

ZONISAMIDE

Application Number

214492

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2021-01-26

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
    185 View
  • Drug Prices in Switzerland
    0 View
Drug Status Breakdown
185 total
  • RX
  • Discontinued
  • OTC
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

ALFUZOSIN HYDROCHLORIDE

Application Number

203192

Product Number

1

Active Ingredient

ALFUZOSIN HYDROCHLORIDE

Dosage Form

-

Strength

10MG

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