Zydus Lifesciences
FDA Approved Drugs

Zydus Lifesciences

FDA Approved Drugs Database

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

RX Discontinued Unclassified
  • Total Records 245
  • Latest Approval Date Aug 03, 2026
  • Data Source FDA
  • First Approval Date Apr 20, 2005
All
245
View
Unclassified
3
View
Discontinued
31
View
RX
211
View
Company Overview

Company

Zydus Lifesciences

Country

India

Website

Visit Website

Email

Social Profiles

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Company Snapshot

Zydus Lifesciences

Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej - Gandhinagar Hwy, Ahmedabad, 382481

India

www.zyduscadila.com/ View on Map
FDA Approved Drug Records ( 245 records )
2019
16 Jan
RX Application: 205301

Drug Name

ACETAZOLAMIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2019-01-16

205301 / 1

Active Ingredient

ACETAZOLAMIDE

Application Number

205301

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2019-01-16

Regulatory Status

RX

2023
04 Apr
RX Application: 211069

Drug Name

ACETAZOLAMIDE

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2023-04-04

211069 / 1

Active Ingredient

ACETAZOLAMIDE

Application Number

211069

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2023-04-04

Regulatory Status

RX

2023
04 Apr
RX Application: 211069

Drug Name

ACETAZOLAMIDE

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2023-04-04

211069 / 2

Active Ingredient

ACETAZOLAMIDE

Application Number

211069

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2023-04-04

Regulatory Status

RX

2016
25 Mar
RX Application: 204313

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2016-03-25

204313 / 1

Active Ingredient

ACYCLOVIR

Application Number

204313

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2016-03-25

Regulatory Status

RX

2019
15 Mar
RX Application: 205974

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2019-03-15

205974 / 1

Active Ingredient

ACYCLOVIR

Application Number

205974

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2019-03-15

Regulatory Status

RX

2023
28 Feb
RX Application: 206770

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2023-02-28

206770 / 1

Active Ingredient

ACYCLOVIR

Application Number

206770

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2023-02-28

Regulatory Status

RX

2026
15 May
RX Application: 217758

Drug Name

AMMONIUM LACTATE

Product Number

1

Dosage Form

-

Strength

EQ 12% BASE

Approval Date

2026-05-15

217758 / 1

Active Ingredient

AMMONIUM LACTATE

Application Number

217758

Product Number

1

Dosage Form

-

Strength

EQ 12% BASE

Approval Date

2026-05-15

Regulatory Status

RX

2026
12 Feb
RX Application: 217815

Drug Name

AMMONIUM LACTATE

Product Number

1

Dosage Form

-

Strength

EQ 12% BASE

Approval Date

2026-02-12

217815 / 1

Active Ingredient

AMMONIUM LACTATE

Application Number

217815

Product Number

1

Dosage Form

-

Strength

EQ 12% BASE

Approval Date

2026-02-12

Regulatory Status

RX

2025
17 Mar
RX Application: 217113

Drug Name

APALUTAMIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2025-03-17

217113 / 1

Active Ingredient

APALUTAMIDE

Application Number

217113

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2025-03-17

Regulatory Status

RX

2018
31 Jul
RX Application: 211147

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/5ML

Approval Date

2018-07-31

211147 / 1

Active Ingredient

AZITHROMYCIN

Application Number

211147

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/5ML

Approval Date

2018-07-31

Regulatory Status

RX

2018
31 Jul
RX Application: 211147

Drug Name

AZITHROMYCIN

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

2018-07-31

211147 / 2

Active Ingredient

AZITHROMYCIN

Application Number

211147

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

2018-07-31

Regulatory Status

RX

2018
23 Nov
RX Application: 211659

Drug Name

BACLOFEN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-11-23

211659 / 1

Active Ingredient

BACLOFEN

Application Number

211659

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-11-23

Regulatory Status

RX

2018
23 Nov
RX Application: 211659

Drug Name

BACLOFEN

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-11-23

211659 / 2

Active Ingredient

BACLOFEN

Application Number

211659

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-11-23

Regulatory Status

RX

2020
17 Apr
RX Application: 211659

Drug Name

BACLOFEN

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2020-04-17

211659 / 3

Active Ingredient

BACLOFEN

Application Number

211659

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2020-04-17

Regulatory Status

RX

2024
13 Feb
RX Application: 211659

Drug Name

BACLOFEN

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2024-02-13

211659 / 4

Active Ingredient

BACLOFEN

Application Number

211659

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2024-02-13

Regulatory Status

RX

2023
08 Jun
RX Application: 217592

Drug Name

BALSALAZIDE DISODIUM

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2023-06-08

217592 / 1

Active Ingredient

BALSALAZIDE DISODIUM

Application Number

217592

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2023-06-08

Regulatory Status

RX

2008
23 May
RX Application: 78848

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-05-23

78848 / 1

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

78848

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-05-23

Regulatory Status

RX

2008
23 May
RX Application: 78848

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-05-23

78848 / 2

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

78848

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-05-23

Regulatory Status

RX

2008
23 May
RX Application: 78848

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2008-05-23

78848 / 3

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

78848

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2008-05-23

Regulatory Status

RX

2008
23 May
RX Application: 78848

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2008-05-23

78848 / 4

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

78848

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2008-05-23

Regulatory Status

RX

2020
14 Jul
RX Application: 214048

Drug Name

BETAMETHASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

2020-07-14

214048 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

214048

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

2020-07-14

Regulatory Status

RX

2022
25 Jul
RX Application: 215680

Drug Name

BISOPROLOL FUMARATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2022-07-25

215680 / 1

Active Ingredient

BISOPROLOL FUMARATE

Application Number

215680

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2022-07-25

Regulatory Status

RX

2022
25 Jul
RX Application: 215680

Drug Name

BISOPROLOL FUMARATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2022-07-25

215680 / 2

Active Ingredient

BISOPROLOL FUMARATE

Application Number

215680

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2022-07-25

Regulatory Status

RX

2022
04 Nov
RX Application: 215666

Drug Name

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

2.5MG;6.25MG

Approval Date

2022-11-04

215666 / 1

Active Ingredient

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Application Number

215666

Product Number

1

Dosage Form

-

Strength

2.5MG;6.25MG

Approval Date

2022-11-04

Regulatory Status

RX

2022
04 Nov
RX Application: 215666

Drug Name

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2022-11-04

215666 / 2

Active Ingredient

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Application Number

215666

Product Number

2

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2022-11-04

Regulatory Status

RX

2022
04 Nov
RX Application: 215666

Drug Name

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

10MG;6.25MG

Approval Date

2022-11-04

215666 / 3

Active Ingredient

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Application Number

215666

Product Number

3

Dosage Form

-

Strength

10MG;6.25MG

Approval Date

2022-11-04

Regulatory Status

RX

2017
23 Aug
RX Application: 91390

Drug Name

CANDESARTAN CILEXETIL

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2017-08-23

91390 / 1

Active Ingredient

CANDESARTAN CILEXETIL

Application Number

91390

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2017-08-23

Regulatory Status

RX

2017
23 Aug
RX Application: 91390

Drug Name

CANDESARTAN CILEXETIL

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2017-08-23

91390 / 2

Active Ingredient

CANDESARTAN CILEXETIL

Application Number

91390

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2017-08-23

Regulatory Status

RX

2017
23 Aug
RX Application: 91390

Drug Name

CANDESARTAN CILEXETIL

Product Number

3

Dosage Form

-

Strength

16MG

Approval Date

2017-08-23

91390 / 3

Active Ingredient

CANDESARTAN CILEXETIL

Application Number

91390

Product Number

3

Dosage Form

-

Strength

16MG

Approval Date

2017-08-23

Regulatory Status

RX

2017
23 Aug
RX Application: 91390

Drug Name

CANDESARTAN CILEXETIL

Product Number

4

Dosage Form

-

Strength

32MG

Approval Date

2017-08-23

91390 / 4

Active Ingredient

CANDESARTAN CILEXETIL

Application Number

91390

Product Number

4

Dosage Form

-

Strength

32MG

Approval Date

2017-08-23

Regulatory Status

RX

2017
27 Nov
RX Application: 203466

Drug Name

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

16MG;12.5MG

Approval Date

2017-11-27

203466 / 1

Active Ingredient

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Application Number

203466

Product Number

1

Dosage Form

-

Strength

16MG;12.5MG

Approval Date

2017-11-27

Regulatory Status

RX

2017
27 Nov
RX Application: 203466

Drug Name

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

32MG;12.5MG

Approval Date

2017-11-27

203466 / 2

Active Ingredient

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Application Number

203466

Product Number

2

Dosage Form

-

Strength

32MG;12.5MG

Approval Date

2017-11-27

Regulatory Status

RX

2017
27 Nov
RX Application: 203466

Drug Name

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

32MG;25MG

Approval Date

2017-11-27

203466 / 3

Active Ingredient

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Application Number

203466

Product Number

3

Dosage Form

-

Strength

32MG;25MG

Approval Date

2017-11-27

Regulatory Status

RX

2026
11 Mar
RX Application: 220267

Drug Name

CEVIMELINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2026-03-11

220267 / 1

Active Ingredient

CEVIMELINE HYDROCHLORIDE

Application Number

220267

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2026-03-11

Regulatory Status

RX

2020
17 Jan
RX Application: 213368

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2020-01-17

213368 / 1

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

213368

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2020-01-17

Regulatory Status

RX

2020
17 Jan
RX Application: 213368

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2020-01-17

213368 / 2

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

213368

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2020-01-17

Regulatory Status

RX

2020
17 Jan
RX Application: 213368

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2020-01-17

213368 / 3

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

213368

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2020-01-17

Regulatory Status

RX

2020
17 Jan
RX Application: 213368

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2020-01-17

213368 / 4

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

213368

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2020-01-17

Regulatory Status

RX

2020
17 Jan
RX Application: 213368

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

200MG

Approval Date

2020-01-17

213368 / 5

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

213368

Product Number

5

Dosage Form

-

Strength

200MG

Approval Date

2020-01-17

Regulatory Status

RX

2018
16 Jul
RX Application: 208767

Drug Name

CLINDAMYCIN PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 1% BASE

Approval Date

2018-07-16

208767 / 1

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

208767

Product Number

1

Dosage Form

-

Strength

EQ 1% BASE

Approval Date

2018-07-16

Regulatory Status

RX

2023
19 Sep
RX Application: 216587

Drug Name

CLINDAMYCIN PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 1% BASE

Approval Date

2023-09-19

216587 / 1

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

216587

Product Number

1

Dosage Form

-

Strength

EQ 1% BASE

Approval Date

2023-09-19

Regulatory Status

RX

2019
24 Sep
RX Application: 205249

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2019-09-24

205249 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

205249

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2019-09-24

Regulatory Status

RX

2012
10 Oct
Discontinued Application: 201686

Drug Name

CLOPIDOGREL BISULFATE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2012-10-10

201686 / 1

Active Ingredient

CLOPIDOGREL BISULFATE

Application Number

201686

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2012-10-10

Regulatory Status

Discontinued

2023
13 Dec
RX Application: 211552

Drug Name

CYCLOPHOSPHAMIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2023-12-13

211552 / 1

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

211552

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2023-12-13

Regulatory Status

RX

2023
13 Dec
RX Application: 211552

Drug Name

CYCLOPHOSPHAMIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2023-12-13

211552 / 2

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

211552

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2023-12-13

Regulatory Status

RX

2024
08 May
RX Application: 214019

Drug Name

DAPSONE

Product Number

1

Dosage Form

-

Strength

7.5%

Approval Date

2024-05-08

214019 / 1

Active Ingredient

DAPSONE

Application Number

214019

Product Number

1

Dosage Form

-

Strength

7.5%

Approval Date

2024-05-08

Regulatory Status

RX

2026
26 Feb
RX Application: 220103

Drug Name

DAPSONE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2026-02-26

220103 / 1

Active Ingredient

DAPSONE

Application Number

220103

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2026-02-26

Regulatory Status

RX

2026
26 Feb
RX Application: 220103

Drug Name

DAPSONE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2026-02-26

220103 / 2

Active Ingredient

DAPSONE

Application Number

220103

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2026-02-26

Regulatory Status

RX

2023
13 Dec
RX Application: 214085

Drug Name

DARUNAVIR

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2023-12-13

214085 / 1

Active Ingredient

DARUNAVIR

Application Number

214085

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2023-12-13

Regulatory Status

RX

2023
13 Dec
RX Application: 214085

Drug Name

DARUNAVIR

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2023-12-13

214085 / 2

Active Ingredient

DARUNAVIR

Application Number

214085

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2023-12-13

Regulatory Status

RX

-
Unclassified Application: 214085

Drug Name

DARUNAVIR

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

-

214085 / 3

Active Ingredient

DARUNAVIR

Application Number

214085

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214085

Drug Name

DARUNAVIR

Product Number

4

Dosage Form

-

Strength

150MG

Approval Date

-

214085 / 4

Active Ingredient

DARUNAVIR

Application Number

214085

Product Number

4

Dosage Form

-

Strength

150MG

Approval Date

-

Regulatory Status

Unclassified

2025
03 Oct
RX Application: 220042

Drug Name

DEFLAZACORT

Product Number

1

Dosage Form

-

Strength

22.75MG/ML

Approval Date

2025-10-03

220042 / 1

Active Ingredient

DEFLAZACORT

Application Number

220042

Product Number

1

Dosage Form

-

Strength

22.75MG/ML

Approval Date

2025-10-03

Regulatory Status

RX

2019
20 Nov
RX Application: 210198

Drug Name

DESONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2019-11-20

210198 / 1

Active Ingredient

DESONIDE

Application Number

210198

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2019-11-20

Regulatory Status

RX

2017
19 Sep
RX Application: 205206

Drug Name

DESOXIMETASONE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2017-09-19

205206 / 1

Active Ingredient

DESOXIMETASONE

Application Number

205206

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2017-09-19

Regulatory Status

RX

2018
28 Sep
RX Application: 205620

Drug Name

DESOXIMETASONE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2018-09-28

205620 / 1

Active Ingredient

DESOXIMETASONE

Application Number

205620

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2018-09-28

Regulatory Status

RX

2024
07 Feb
RX Application: 216282

Drug Name

DEXAMETHASONE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2024-02-07

216282 / 1

Active Ingredient

DEXAMETHASONE

Application Number

216282

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2024-02-07

Regulatory Status

RX

2024
07 Feb
RX Application: 216282

Drug Name

DEXAMETHASONE

Product Number

2

Dosage Form

-

Strength

0.75MG

Approval Date

2024-02-07

216282 / 2

Active Ingredient

DEXAMETHASONE

Application Number

216282

Product Number

2

Dosage Form

-

Strength

0.75MG

Approval Date

2024-02-07

Regulatory Status

RX

2024
07 Feb
RX Application: 216282

Drug Name

DEXAMETHASONE

Product Number

3

Dosage Form

-

Strength

1.5MG

Approval Date

2024-02-07

216282 / 3

Active Ingredient

DEXAMETHASONE

Application Number

216282

Product Number

3

Dosage Form

-

Strength

1.5MG

Approval Date

2024-02-07

Regulatory Status

RX

2024
07 Feb
RX Application: 216282

Drug Name

DEXAMETHASONE

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

2024-02-07

216282 / 4

Active Ingredient

DEXAMETHASONE

Application Number

216282

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

2024-02-07

Regulatory Status

RX

2024
07 Feb
RX Application: 216282

Drug Name

DEXAMETHASONE

Product Number

5

Dosage Form

-

Strength

6MG

Approval Date

2024-02-07

216282 / 5

Active Ingredient

DEXAMETHASONE

Application Number

216282

Product Number

5

Dosage Form

-

Strength

6MG

Approval Date

2024-02-07

Regulatory Status

RX

2024
07 Feb
RX Application: 216283

Drug Name

DEXAMETHASONE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2024-02-07

216283 / 1

Active Ingredient

DEXAMETHASONE

Application Number

216283

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2024-02-07

Regulatory Status

RX

2024
09 May
RX Application: 216284

Drug Name

DEXAMETHASONE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2024-05-09

216284 / 1

Active Ingredient

DEXAMETHASONE

Application Number

216284

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2024-05-09

Regulatory Status

RX

2018
17 Apr
RX Application: 206411

Drug Name

DICLOFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

2018-04-17

206411 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

206411

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

2018-04-17

Regulatory Status

RX

2025
08 Aug
RX Application: 219253

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2025-08-08

219253 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

219253

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2025-08-08

Regulatory Status

RX

2025
08 Aug
RX Application: 219253

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2025-08-08

219253 / 2

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

219253

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2025-08-08

Regulatory Status

RX

2025
08 Aug
RX Application: 219253

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

90MG

Approval Date

2025-08-08

219253 / 3

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

219253

Product Number

3

Dosage Form

-

Strength

90MG

Approval Date

2025-08-08

Regulatory Status

RX

2025
08 Aug
RX Application: 219253

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

120MG

Approval Date

2025-08-08

219253 / 4

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

219253

Product Number

4

Dosage Form

-

Strength

120MG

Approval Date

2025-08-08

Regulatory Status

RX

2012
24 Oct
RX Application: 90100

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2012-10-24

90100 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

90100

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2012-10-24

Regulatory Status

RX

2012
24 Oct
RX Application: 90100

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2012-10-24

90100 / 2

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

90100

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2012-10-24

Regulatory Status

RX

2023
16 Aug
RX Application: 202761

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2023-08-16

202761 / 1

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

202761

Product Number

1

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2023-08-16

Regulatory Status

RX

2023
16 Aug
RX Application: 202761

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2023-08-16

202761 / 2

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

202761

Product Number

2

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2023-08-16

Regulatory Status

RX

2023
21 Mar
RX Application: 210140

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2023-03-21

210140 / 1

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

210140

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2023-03-21

Regulatory Status

RX

2023
23 Mar
RX Application: 210700

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2023-03-23

210700 / 1

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

210700

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2023-03-23

Regulatory Status

RX

2023
23 Mar
RX Application: 210700

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2023-03-23

210700 / 2

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

210700

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2023-03-23

Regulatory Status

RX

2023
23 Mar
RX Application: 210700

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2023-03-23

210700 / 3

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

210700

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2023-03-23

Regulatory Status

RX

2023
23 Mar
RX Application: 210700

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2023-03-23

210700 / 4

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

210700

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2023-03-23

Regulatory Status

RX

2023
23 Mar
RX Application: 210700

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2023-03-23

210700 / 5

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

210700

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2023-03-23

Regulatory Status

RX

2020
10 Sep
RX Application: 212299

Drug Name

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

Product Number

1

Dosage Form

-

Strength

20MG/10ML (2MG/ML)

Approval Date

2020-09-10

212299 / 1

Active Ingredient

DOXORUBICIN HYDROCHLORIDE

Application Number

212299

Product Number

1

Dosage Form

-

Strength

20MG/10ML (2MG/ML)

Approval Date

2020-09-10

Regulatory Status

RX

2020
10 Sep
RX Application: 212299

Drug Name

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

Product Number

2

Dosage Form

-

Strength

50MG/25ML (2MG/ML)

Approval Date

2020-09-10

212299 / 2

Active Ingredient

DOXORUBICIN HYDROCHLORIDE

Application Number

212299

Product Number

2

Dosage Form

-

Strength

50MG/25ML (2MG/ML)

Approval Date

2020-09-10

Regulatory Status

RX

2017
30 Oct
RX Application: 207773

Drug Name

DOXYCYCLINE HYCLATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2017-10-30

207773 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

207773

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2017-10-30

Regulatory Status

RX

2018
31 May
RX Application: 207774

Drug Name

DOXYCYCLINE HYCLATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2018-05-31

207774 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

207774

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2018-05-31

Regulatory Status

RX

2018
31 May
RX Application: 207774

Drug Name

DOXYCYCLINE HYCLATE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2018-05-31

207774 / 2

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

207774

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2018-05-31

Regulatory Status

RX

2017
04 Oct
RX Application: 204373

Drug Name

DUTASTERIDE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2017-10-04

204373 / 1

Active Ingredient

DUTASTERIDE

Application Number

204373

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2017-10-04

Regulatory Status

RX

2022
15 Jul
Discontinued Application: 212178

Drug Name

EFINACONAZOLE

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2022-07-15

212178 / 1

Active Ingredient

EFINACONAZOLE

Application Number

212178

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2022-07-15

Regulatory Status

Discontinued

2023
07 Mar
RX Application: 212693

Drug Name

ERYTHROMYCIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2023-03-07

212693 / 1

Active Ingredient

ERYTHROMYCIN

Application Number

212693

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2023-03-07

Regulatory Status

RX

2023
07 Mar
RX Application: 212693

Drug Name

ERYTHROMYCIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2023-03-07

212693 / 2

Active Ingredient

ERYTHROMYCIN

Application Number

212693

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2023-03-07

Regulatory Status

RX

2012
11 Sep
RX Application: 77734

Drug Name

ESCITALOPRAM OXALATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-09-11

77734 / 1

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

77734

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-09-11

Regulatory Status

RX

2012
11 Sep
RX Application: 77734

Drug Name

ESCITALOPRAM OXALATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-09-11

77734 / 2

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

77734

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-09-11

Regulatory Status

RX

2012
11 Sep
RX Application: 77734

Drug Name

ESCITALOPRAM OXALATE

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-09-11

77734 / 3

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

77734

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-09-11

Regulatory Status

RX

2023
09 Jan
RX Application: 205443

Drug Name

FEBUXOSTAT

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2023-01-09

205443 / 1

Active Ingredient

FEBUXOSTAT

Application Number

205443

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2023-01-09

Regulatory Status

RX

2023
09 Jan
RX Application: 205443

Drug Name

FEBUXOSTAT

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2023-01-09

205443 / 2

Active Ingredient

FEBUXOSTAT

Application Number

205443

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2023-01-09

Regulatory Status

RX

2017
30 May
RX Application: 208970

Drug Name

FELBAMATE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2017-05-30

208970 / 1

Active Ingredient

FELBAMATE

Application Number

208970

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2017-05-30

Regulatory Status

RX

2017
30 May
RX Application: 208970

Drug Name

FELBAMATE

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2017-05-30

208970 / 2

Active Ingredient

FELBAMATE

Application Number

208970

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2017-05-30

Regulatory Status

RX

2024
15 Mar
Discontinued Application: 218232

Drug Name

FINASTERIDE AND TADALAFIL

Product Number

1

Dosage Form

-

Strength

5MG;5MG

Approval Date

2024-03-15

218232 / 1

Active Ingredient

FINASTERIDE; TADALAFIL

Application Number

218232

Product Number

1

Dosage Form

-

Strength

5MG;5MG

Approval Date

2024-03-15

Regulatory Status

Discontinued

2024
16 Oct
RX Application: 219251

Drug Name

FLUDROCORTISONE ACETATE

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2024-10-16

219251 / 1

Active Ingredient

FLUDROCORTISONE ACETATE

Application Number

219251

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2024-10-16

Regulatory Status

RX

2020
10 Feb
RX Application: 208989

Drug Name

FLUOCINONIDE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2020-02-10

208989 / 1

Active Ingredient

FLUOCINONIDE

Application Number

208989

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2020-02-10

Regulatory Status

RX

2026
01 Jun
RX Application: 218651

Drug Name

FLUORESCEIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

Approval Date

2026-06-01

218651 / 1

Active Ingredient

FLUORESCEIN SODIUM

Application Number

218651

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

Approval Date

2026-06-01

Regulatory Status

RX

2026
01 Jun
RX Application: 218651

Drug Name

FLUORESCEIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/2ML (EQ 250MG BASE/ML)

Approval Date

2026-06-01

218651 / 2

Active Ingredient

FLUORESCEIN SODIUM

Application Number

218651

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/2ML (EQ 250MG BASE/ML)

Approval Date

2026-06-01

Regulatory Status

RX

2021
27 May
RX Application: 214552

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2021-05-27

214552 / 1

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

214552

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2021-05-27

Regulatory Status

RX

2021
27 May
RX Application: 214552

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2021-05-27

214552 / 2

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

214552

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2021-05-27

Regulatory Status

RX

2021
27 May
RX Application: 214552

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2021-05-27

214552 / 3

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

214552

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2021-05-27

Regulatory Status

RX

2021
27 May
RX Application: 214552

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2021-05-27

214552 / 4

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

214552

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2021-05-27

Regulatory Status

RX

2018
28 Aug
Discontinued Application: 204189

Drug Name

GEMFIBROZIL

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2018-08-28

204189 / 1

Active Ingredient

GEMFIBROZIL

Application Number

204189

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2018-08-28

Regulatory Status

Discontinued

2021
31 Mar
Discontinued Application: 211344

Drug Name

IBRUTINIB

Product Number

1

Dosage Form

-

Strength

70MG

Approval Date

2021-03-31

211344 / 1

Active Ingredient

IBRUTINIB

Application Number

211344

Product Number

1

Dosage Form

-

Strength

70MG

Approval Date

2021-03-31

Regulatory Status

Discontinued

2021
31 Mar
Discontinued Application: 211344

Drug Name

IBRUTINIB

Product Number

2

Dosage Form

-

Strength

140MG

Approval Date

2021-03-31

211344 / 2

Active Ingredient

IBRUTINIB

Application Number

211344

Product Number

2

Dosage Form

-

Strength

140MG

Approval Date

2021-03-31

Regulatory Status

Discontinued

2025
20 Feb
RX Application: 218684

Drug Name

IBUPROFEN AND FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

26.6MG;800MG

Approval Date

2025-02-20

218684 / 1

Active Ingredient

FAMOTIDINE; IBUPROFEN

Application Number

218684

Product Number

1

Dosage Form

-

Strength

26.6MG;800MG

Approval Date

2025-02-20

Regulatory Status

RX

2023
20 Apr
RX Application: 217656

Drug Name

ICOSAPENT ETHYL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2023-04-20

217656 / 1

Active Ingredient

ICOSAPENT ETHYL

Application Number

217656

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2023-04-20

Regulatory Status

RX

2023
20 Apr
RX Application: 217656

Drug Name

ICOSAPENT ETHYL

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2023-04-20

217656 / 2

Active Ingredient

ICOSAPENT ETHYL

Application Number

217656

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2023-04-20

Regulatory Status

RX

2026
03 Aug
RX Application: 219139

Drug Name

INDOCYANINE GREEN

Product Number

1

Dosage Form

-

Strength

25MG/VIAL

Approval Date

2026-08-03

219139 / 1

Active Ingredient

INDOCYANINE GREEN

Application Number

219139

Product Number

1

Dosage Form

-

Strength

25MG/VIAL

Approval Date

2026-08-03

Regulatory Status

RX

2010
15 Nov
RX Application: 90403

Drug Name

INDOMETHACIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2010-11-15

90403 / 1

Active Ingredient

INDOMETHACIN

Application Number

90403

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2010-11-15

Regulatory Status

RX

2010
15 Nov
RX Application: 90403

Drug Name

INDOMETHACIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2010-11-15

90403 / 2

Active Ingredient

INDOMETHACIN

Application Number

90403

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2010-11-15

Regulatory Status

RX

2023
02 Aug
RX Application: 216184

Drug Name

INDOMETHACIN

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2023-08-02

216184 / 1

Active Ingredient

INDOMETHACIN

Application Number

216184

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2023-08-02

Regulatory Status

RX

2019
20 Nov
RX Application: 213057

Drug Name

ISOSORBIDE DINITRATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-11-20

213057 / 1

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

213057

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-11-20

Regulatory Status

RX

2019
20 Nov
RX Application: 213057

Drug Name

ISOSORBIDE DINITRATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-11-20

213057 / 2

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

213057

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-11-20

Regulatory Status

RX

2019
20 Nov
RX Application: 213057

Drug Name

ISOSORBIDE DINITRATE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2019-11-20

213057 / 3

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

213057

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2019-11-20

Regulatory Status

RX

2019
20 Nov
RX Application: 213057

Drug Name

ISOSORBIDE DINITRATE

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2019-11-20

213057 / 4

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

213057

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2019-11-20

Regulatory Status

RX

2019
20 Nov
RX Application: 213057

Drug Name

ISOSORBIDE DINITRATE

Product Number

5

Dosage Form

-

Strength

40MG

Approval Date

2019-11-20

213057 / 5

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

213057

Product Number

5

Dosage Form

-

Strength

40MG

Approval Date

2019-11-20

Regulatory Status

RX

2022
02 Aug
RX Application: 215210

Drug Name

IVERMECTIN

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2022-08-02

215210 / 1

Active Ingredient

IVERMECTIN

Application Number

215210

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2022-08-02

Regulatory Status

RX

2026
26 Feb
RX Application: 216863

Drug Name

IVERMECTIN

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2026-02-26

216863 / 1

Active Ingredient

IVERMECTIN

Application Number

216863

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2026-02-26

Regulatory Status

RX

2025
08 Apr
RX Application: 219254

Drug Name

JAYTHARI

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

2025-04-08

219254 / 1

Active Ingredient

DEFLAZACORT

Application Number

219254

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

2025-04-08

Regulatory Status

RX

2025
08 Apr
RX Application: 219254

Drug Name

JAYTHARI

Product Number

2

Dosage Form

-

Strength

18MG

Approval Date

2025-04-08

219254 / 2

Active Ingredient

DEFLAZACORT

Application Number

219254

Product Number

2

Dosage Form

-

Strength

18MG

Approval Date

2025-04-08

Regulatory Status

RX

2025
08 Apr
RX Application: 219254

Drug Name

JAYTHARI

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2025-04-08

219254 / 3

Active Ingredient

DEFLAZACORT

Application Number

219254

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2025-04-08

Regulatory Status

RX

2025
08 Apr
RX Application: 219254

Drug Name

JAYTHARI

Product Number

4

Dosage Form

-

Strength

36MG

Approval Date

2025-04-08

219254 / 4

Active Ingredient

DEFLAZACORT

Application Number

219254

Product Number

4

Dosage Form

-

Strength

36MG

Approval Date

2025-04-08

Regulatory Status

RX

2025
07 Mar
RX Application: 218559

Drug Name

KETOCONAZOLE

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2025-03-07

218559 / 1

Active Ingredient

KETOCONAZOLE

Application Number

218559

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2025-03-07

Regulatory Status

RX

2022
21 Oct
RX Application: 217038

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2022-10-21

217038 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

217038

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2022-10-21

Regulatory Status

RX

2019
24 Apr
RX Application: 212308

Drug Name

LEFLUNOMIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2019-04-24

212308 / 1

Active Ingredient

LEFLUNOMIDE

Application Number

212308

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2019-04-24

Regulatory Status

RX

2019
24 Apr
RX Application: 212308

Drug Name

LEFLUNOMIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2019-04-24

212308 / 2

Active Ingredient

LEFLUNOMIDE

Application Number

212308

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2019-04-24

Regulatory Status

RX

2012
07 Sep
RX Application: 77652

Drug Name

LEVOFLOXACIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2012-09-07

77652 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

77652

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2012-09-07

Regulatory Status

RX

2012
07 Sep
RX Application: 77652

Drug Name

LEVOFLOXACIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2012-09-07

77652 / 2

Active Ingredient

LEVOFLOXACIN

Application Number

77652

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2012-09-07

Regulatory Status

RX

2012
07 Sep
RX Application: 77652

Drug Name

LEVOFLOXACIN

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2012-09-07

77652 / 3

Active Ingredient

LEVOFLOXACIN

Application Number

77652

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2012-09-07

Regulatory Status

RX

2024
17 Dec
RX Application: 219120

Drug Name

LIDOCAINE AND PRILOCAINE

Product Number

1

Dosage Form

-

Strength

2.5%;2.5%

Approval Date

2024-12-17

219120 / 1

Active Ingredient

LIDOCAINE; PRILOCAINE

Application Number

219120

Product Number

1

Dosage Form

-

Strength

2.5%;2.5%

Approval Date

2024-12-17

Regulatory Status

RX

2021
22 Jan
RX Application: 214803

Drug Name

LIOTHYRONINE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 0.005MG BASE

Approval Date

2021-01-22

214803 / 1

Active Ingredient

LIOTHYRONINE SODIUM

Application Number

214803

Product Number

1

Dosage Form

-

Strength

EQ 0.005MG BASE

Approval Date

2021-01-22

Regulatory Status

RX

2021
22 Jan
RX Application: 214803

Drug Name

LIOTHYRONINE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 0.025MG BASE

Approval Date

2021-01-22

214803 / 2

Active Ingredient

LIOTHYRONINE SODIUM

Application Number

214803

Product Number

2

Dosage Form

-

Strength

EQ 0.025MG BASE

Approval Date

2021-01-22

Regulatory Status

RX

2021
22 Jan
RX Application: 214803

Drug Name

LIOTHYRONINE SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 0.05MG BASE

Approval Date

2021-01-22

214803 / 3

Active Ingredient

LIOTHYRONINE SODIUM

Application Number

214803

Product Number

3

Dosage Form

-

Strength

EQ 0.05MG BASE

Approval Date

2021-01-22

Regulatory Status

RX

2023
23 Mar
RX Application: 217471

Drug Name

LOPERAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2023-03-23

217471 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE

Application Number

217471

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2023-03-23

Regulatory Status

RX

2021
06 Apr
RX Application: 211224

Drug Name

MACITENTAN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-04-06

211224 / 1

Active Ingredient

MACITENTAN

Application Number

211224

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-04-06

Regulatory Status

RX

2020
23 Jun
RX Application: 213957

Drug Name

MECLIZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2020-06-23

213957 / 1

Active Ingredient

MECLIZINE HYDROCHLORIDE

Application Number

213957

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2020-06-23

Regulatory Status

RX

2020
23 Jun
RX Application: 213957

Drug Name

MECLIZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2020-06-23

213957 / 2

Active Ingredient

MECLIZINE HYDROCHLORIDE

Application Number

213957

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2020-06-23

Regulatory Status

RX

2017
10 Jul
RX Application: 90961

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2017-07-10

90961 / 1

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

90961

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2017-07-10

Regulatory Status

RX

2017
10 Jul
RX Application: 90961

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2017-07-10

90961 / 2

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

90961

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2017-07-10

Regulatory Status

RX

2005
20 Apr
RX Application: 77060

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2005-04-20

77060 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

77060

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2005-04-20

Regulatory Status

RX

2005
21 Apr
RX Application: 77078

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2005-04-21

77078 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

77078

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2005-04-21

Regulatory Status

RX

2025
10 Mar
RX Application: 219661

Drug Name

METHENAMINE HIPPURATE

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2025-03-10

219661 / 1

Active Ingredient

METHENAMINE HIPPURATE

Application Number

219661

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2025-03-10

Regulatory Status

RX

2023
05 Dec
RX Application: 215636

Drug Name

METHYLENE BLUE

Product Number

1

Dosage Form

-

Strength

10MG/2ML (5MG/ML)

Approval Date

2023-12-05

215636 / 1

Active Ingredient

METHYLENE BLUE

Application Number

215636

Product Number

1

Dosage Form

-

Strength

10MG/2ML (5MG/ML)

Approval Date

2023-12-05

Regulatory Status

RX

2023
05 Dec
RX Application: 215636

Drug Name

METHYLENE BLUE

Product Number

2

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2023-12-05

215636 / 2

Active Ingredient

METHYLENE BLUE

Application Number

215636

Product Number

2

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2023-12-05

Regulatory Status

RX

2026
02 Feb
RX Application: 215636

Drug Name

METHYLENE BLUE

Product Number

3

Dosage Form

-

Strength

5MG/ML (5MG/ML)

Approval Date

2026-02-02

215636 / 3

Active Ingredient

METHYLENE BLUE

Application Number

215636

Product Number

3

Dosage Form

-

Strength

5MG/ML (5MG/ML)

Approval Date

2026-02-02

Regulatory Status

RX

2026
31 Mar
RX Application: 215636

Drug Name

METHYLENE BLUE

Product Number

4

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2026-03-31

215636 / 4

Active Ingredient

METHYLENE BLUE

Application Number

215636

Product Number

4

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2026-03-31

Regulatory Status

RX

2016
16 Nov
RX Application: 206560

Drug Name

METRONIDAZOLE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2016-11-16

206560 / 1

Active Ingredient

METRONIDAZOLE

Application Number

206560

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2016-11-16

Regulatory Status

RX

2016
16 Nov
RX Application: 206560

Drug Name

METRONIDAZOLE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2016-11-16

206560 / 2

Active Ingredient

METRONIDAZOLE

Application Number

206560

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2016-11-16

Regulatory Status

RX

2023
21 Apr
RX Application: 217128

Drug Name

METRONIDAZOLE

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

2023-04-21

217128 / 1

Active Ingredient

METRONIDAZOLE

Application Number

217128

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

2023-04-21

Regulatory Status

RX

2026
13 Feb
RX Application: 220095

Drug Name

METRONIDAZOLE

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

2026-02-13

220095 / 1

Active Ingredient

METRONIDAZOLE

Application Number

220095

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

2026-02-13

Regulatory Status

RX

2020
01 Sep
RX Application: 213055

Drug Name

MIDODRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2020-09-01

213055 / 1

Active Ingredient

MIDODRINE HYDROCHLORIDE

Application Number

213055

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2020-09-01

Regulatory Status

RX

2020
01 Sep
RX Application: 213055

Drug Name

MIDODRINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2020-09-01

213055 / 2

Active Ingredient

MIDODRINE HYDROCHLORIDE

Application Number

213055

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2020-09-01

Regulatory Status

RX

2020
01 Sep
RX Application: 213055

Drug Name

MIDODRINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2020-09-01

213055 / 3

Active Ingredient

MIDODRINE HYDROCHLORIDE

Application Number

213055

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2020-09-01

Regulatory Status

RX

2017
14 Sep
RX Application: 209966

Drug Name

MODAFINIL

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2017-09-14

209966 / 1

Active Ingredient

MODAFINIL

Application Number

209966

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2017-09-14

Regulatory Status

RX

2017
14 Sep
RX Application: 209966

Drug Name

MODAFINIL

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2017-09-14

209966 / 2

Active Ingredient

MODAFINIL

Application Number

209966

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2017-09-14

Regulatory Status

RX

2021
24 Feb
Discontinued Application: 213441

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2021-02-24

213441 / 1

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

213441

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2021-02-24

Regulatory Status

Discontinued

2021
24 Feb
Discontinued Application: 213441

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2021-02-24

213441 / 2

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

213441

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2021-02-24

Regulatory Status

Discontinued

2021
24 Feb
Discontinued Application: 213441

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2021-02-24

213441 / 3

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

213441

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2021-02-24

Regulatory Status

Discontinued

2021
24 Feb
Discontinued Application: 213441

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2021-02-24

213441 / 4

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

213441

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2021-02-24

Regulatory Status

Discontinued

2018
25 May
RX Application: 207767

Drug Name

NYSTATIN

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM

Approval Date

2018-05-25

207767 / 1

Active Ingredient

NYSTATIN

Application Number

207767

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM

Approval Date

2018-05-25

Regulatory Status

RX

2018
08 Nov
RX Application: 207764

Drug Name

NYSTATIN AND TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM;0.1%

Approval Date

2018-11-08

207764 / 1

Active Ingredient

NYSTATIN; TRIAMCINOLONE ACETONIDE

Application Number

207764

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM;0.1%

Approval Date

2018-11-08

Regulatory Status

RX

2019
14 Jun
Discontinued Application: 210107

Drug Name

OMEGA-3-ACID ETHYL ESTERS

Product Number

1

Dosage Form

-

Strength

1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS

Approval Date

2019-06-14

210107 / 1

Active Ingredient

OMEGA-3-ACID ETHYL ESTERS

Application Number

210107

Product Number

1

Dosage Form

-

Strength

1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS

Approval Date

2019-06-14

Regulatory Status

Discontinued

2024
05 Jun
Discontinued Application: 215570

Drug Name

PALBOCICLIB

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2024-06-05

215570 / 1

Active Ingredient

PALBOCICLIB

Application Number

215570

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2024-06-05

Regulatory Status

Discontinued

2024
05 Jun
Discontinued Application: 215570

Drug Name

PALBOCICLIB

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2024-06-05

215570 / 2

Active Ingredient

PALBOCICLIB

Application Number

215570

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2024-06-05

Regulatory Status

Discontinued

2024
05 Jun
Discontinued Application: 215570

Drug Name

PALBOCICLIB

Product Number

3

Dosage Form

-

Strength

125MG

Approval Date

2024-06-05

215570 / 3

Active Ingredient

PALBOCICLIB

Application Number

215570

Product Number

3

Dosage Form

-

Strength

125MG

Approval Date

2024-06-05

Regulatory Status

Discontinued

2019
20 Feb
RX Application: 210189

Drug Name

PHYTONADIONE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-02-20

210189 / 1

Active Ingredient

PHYTONADIONE

Application Number

210189

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-02-20

Regulatory Status

RX

2018
17 Jul
RX Application: 205585

Drug Name

PIROXICAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-07-17

205585 / 1

Active Ingredient

PIROXICAM

Application Number

205585

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-07-17

Regulatory Status

RX

2018
17 Jul
RX Application: 205585

Drug Name

PIROXICAM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-07-17

205585 / 2

Active Ingredient

PIROXICAM

Application Number

205585

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-07-17

Regulatory Status

RX

2022
08 Aug
RX Application: 216495

Drug Name

PROCHLORPERAZINE MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2022-08-08

216495 / 1

Active Ingredient

PROCHLORPERAZINE MALEATE

Application Number

216495

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2022-08-08

Regulatory Status

RX

2022
08 Aug
RX Application: 216495

Drug Name

PROCHLORPERAZINE MALEATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2022-08-08

216495 / 2

Active Ingredient

PROCHLORPERAZINE MALEATE

Application Number

216495

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2022-08-08

Regulatory Status

RX

2021
21 Apr
RX Application: 214184

Drug Name

PROPAFENONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

225MG

Approval Date

2021-04-21

214184 / 1

Active Ingredient

PROPAFENONE HYDROCHLORIDE

Application Number

214184

Product Number

1

Dosage Form

-

Strength

225MG

Approval Date

2021-04-21

Regulatory Status

RX

2021
21 Apr
RX Application: 214184

Drug Name

PROPAFENONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

325MG

Approval Date

2021-04-21

214184 / 2

Active Ingredient

PROPAFENONE HYDROCHLORIDE

Application Number

214184

Product Number

2

Dosage Form

-

Strength

325MG

Approval Date

2021-04-21

Regulatory Status

RX

2021
21 Apr
RX Application: 214184

Drug Name

PROPAFENONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

425MG

Approval Date

2021-04-21

214184 / 3

Active Ingredient

PROPAFENONE HYDROCHLORIDE

Application Number

214184

Product Number

3

Dosage Form

-

Strength

425MG

Approval Date

2021-04-21

Regulatory Status

RX

2025
07 Aug
RX Application: 218056

Drug Name

PRUCALOPRIDE SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2025-08-07

218056 / 1

Active Ingredient

PRUCALOPRIDE SUCCINATE

Application Number

218056

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2025-08-07

Regulatory Status

RX

2025
07 Aug
RX Application: 218056

Drug Name

PRUCALOPRIDE SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2025-08-07

218056 / 2

Active Ingredient

PRUCALOPRIDE SUCCINATE

Application Number

218056

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2025-08-07

Regulatory Status

RX

2019
19 Aug
RX Application: 210188

Drug Name

RANOLAZINE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2019-08-19

210188 / 1

Active Ingredient

RANOLAZINE

Application Number

210188

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2019-08-19

Regulatory Status

RX

2019
19 Aug
RX Application: 210188

Drug Name

RANOLAZINE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2019-08-19

210188 / 2

Active Ingredient

RANOLAZINE

Application Number

210188

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2019-08-19

Regulatory Status

RX

-
Unclassified Application: 219519

Drug Name

RIFABUTIN

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

-

219519 / 1

Active Ingredient

RIFABUTIN

Application Number

219519

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

-

Regulatory Status

Unclassified

2009
01 Jun
RX Application: 90411

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

2009-06-01

90411 / 1

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

90411

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

2009-06-01

Regulatory Status

RX

2009
01 Jun
RX Application: 90411

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2009-06-01

90411 / 2

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

90411

Product Number

2

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2009-06-01

Regulatory Status

RX

2009
01 Jun
RX Application: 90411

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2009-06-01

90411 / 3

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

90411

Product Number

3

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2009-06-01

Regulatory Status

RX

2009
01 Jun
RX Application: 90411

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2009-06-01

90411 / 4

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

90411

Product Number

4

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2009-06-01

Regulatory Status

RX

2009
01 Jun
RX Application: 90411

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2009-06-01

90411 / 5

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

90411

Product Number

5

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2009-06-01

Regulatory Status

RX

2009
01 Jun
RX Application: 90411

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2009-06-01

90411 / 6

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

90411

Product Number

6

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2009-06-01

Regulatory Status

RX

2009
01 Jun
RX Application: 90411

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

7

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2009-06-01

90411 / 7

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

90411

Product Number

7

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2009-06-01

Regulatory Status

RX

2022
21 Dec
Discontinued Application: 214302

Drug Name

SELEXIPAG

Product Number

1

Dosage Form

-

Strength

0.2MG

Approval Date

2022-12-21

214302 / 1

Active Ingredient

SELEXIPAG

Application Number

214302

Product Number

1

Dosage Form

-

Strength

0.2MG

Approval Date

2022-12-21

Regulatory Status

Discontinued

2022
21 Dec
Discontinued Application: 214302

Drug Name

SELEXIPAG

Product Number

2

Dosage Form

-

Strength

0.4MG

Approval Date

2022-12-21

214302 / 2

Active Ingredient

SELEXIPAG

Application Number

214302

Product Number

2

Dosage Form

-

Strength

0.4MG

Approval Date

2022-12-21

Regulatory Status

Discontinued

2022
21 Dec
Discontinued Application: 214302

Drug Name

SELEXIPAG

Product Number

3

Dosage Form

-

Strength

0.6MG

Approval Date

2022-12-21

214302 / 3

Active Ingredient

SELEXIPAG

Application Number

214302

Product Number

3

Dosage Form

-

Strength

0.6MG

Approval Date

2022-12-21

Regulatory Status

Discontinued

2022
21 Dec
Discontinued Application: 214302

Drug Name

SELEXIPAG

Product Number

4

Dosage Form

-

Strength

0.8MG

Approval Date

2022-12-21

214302 / 4

Active Ingredient

SELEXIPAG

Application Number

214302

Product Number

4

Dosage Form

-

Strength

0.8MG

Approval Date

2022-12-21

Regulatory Status

Discontinued

2022
21 Dec
Discontinued Application: 214302

Drug Name

SELEXIPAG

Product Number

5

Dosage Form

-

Strength

1MG

Approval Date

2022-12-21

214302 / 5

Active Ingredient

SELEXIPAG

Application Number

214302

Product Number

5

Dosage Form

-

Strength

1MG

Approval Date

2022-12-21

Regulatory Status

Discontinued

2022
21 Dec
Discontinued Application: 214302

Drug Name

SELEXIPAG

Product Number

6

Dosage Form

-

Strength

1.2MG

Approval Date

2022-12-21

214302 / 6

Active Ingredient

SELEXIPAG

Application Number

214302

Product Number

6

Dosage Form

-

Strength

1.2MG

Approval Date

2022-12-21

Regulatory Status

Discontinued

2022
21 Dec
Discontinued Application: 214302

Drug Name

SELEXIPAG

Product Number

7

Dosage Form

-

Strength

1.4MG

Approval Date

2022-12-21

214302 / 7

Active Ingredient

SELEXIPAG

Application Number

214302

Product Number

7

Dosage Form

-

Strength

1.4MG

Approval Date

2022-12-21

Regulatory Status

Discontinued

2022
21 Dec
Discontinued Application: 214302

Drug Name

SELEXIPAG

Product Number

8

Dosage Form

-

Strength

1.6MG

Approval Date

2022-12-21

214302 / 8

Active Ingredient

SELEXIPAG

Application Number

214302

Product Number

8

Dosage Form

-

Strength

1.6MG

Approval Date

2022-12-21

Regulatory Status

Discontinued

2026
29 Jan
RX Application: 220275

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2026-01-29

220275 / 1

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

220275

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2026-01-29

Regulatory Status

RX

2026
29 Jan
RX Application: 220275

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2026-01-29

220275 / 2

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

220275

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2026-01-29

Regulatory Status

RX

2022
29 Sep
RX Application: 215708

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2022-09-29

215708 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

215708

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2022-09-29

Regulatory Status

RX

2023
03 May
RX Application: 215705

Drug Name

SUCRALFATE

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2023-05-03

215705 / 1

Active Ingredient

SUCRALFATE

Application Number

215705

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2023-05-03

Regulatory Status

RX

2023
10 Apr
RX Application: 212294

Drug Name

TAVABOROLE

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2023-04-10

212294 / 1

Active Ingredient

TAVABOROLE

Application Number

212294

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2023-04-10

Regulatory Status

RX

2024
21 May
RX Application: 218063

Drug Name

THEOPHYLLINE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2024-05-21

218063 / 1

Active Ingredient

THEOPHYLLINE

Application Number

218063

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2024-05-21

Regulatory Status

RX

2024
21 May
RX Application: 218063

Drug Name

THEOPHYLLINE

Product Number

2

Dosage Form

-

Strength

450MG

Approval Date

2024-05-21

218063 / 2

Active Ingredient

THEOPHYLLINE

Application Number

218063

Product Number

2

Dosage Form

-

Strength

450MG

Approval Date

2024-05-21

Regulatory Status

RX

2018
09 Mar
RX Application: 208187

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2018-03-09

208187 / 1

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

208187

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2018-03-09

Regulatory Status

RX

2018
09 Mar
RX Application: 208187

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2018-03-09

208187 / 2

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

208187

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2018-03-09

Regulatory Status

RX

2024
25 Apr
RX Application: 218561

Drug Name

TRETINOIN

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2024-04-25

218561 / 1

Active Ingredient

TRETINOIN

Application Number

218561

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2024-04-25

Regulatory Status

RX

2019
11 Feb
RX Application: 208358

Drug Name

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG;37.5MG

Approval Date

2019-02-11

208358 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; TRIAMTERENE

Application Number

208358

Product Number

1

Dosage Form

-

Strength

25MG;37.5MG

Approval Date

2019-02-11

Regulatory Status

RX

2018
30 Oct
RX Application: 211145

Drug Name

URSODIOL

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2018-10-30

211145 / 1

Active Ingredient

URSODIOL

Application Number

211145

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2018-10-30

Regulatory Status

RX

2018
30 Oct
RX Application: 211145

Drug Name

URSODIOL

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2018-10-30

211145 / 2

Active Ingredient

URSODIOL

Application Number

211145

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2018-10-30

Regulatory Status

RX

2020
16 Oct
RX Application: 214295

Drug Name

URSODIOL

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2020-10-16

214295 / 1

Active Ingredient

URSODIOL

Application Number

214295

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2020-10-16

Regulatory Status

RX

2017
29 Dec
RX Application: 79137

Drug Name

VALACYCLOVIR HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2017-12-29

79137 / 1

Active Ingredient

VALACYCLOVIR HYDROCHLORIDE

Application Number

79137

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2017-12-29

Regulatory Status

RX

2017
29 Dec
RX Application: 79137

Drug Name

VALACYCLOVIR HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2017-12-29

79137 / 2

Active Ingredient

VALACYCLOVIR HYDROCHLORIDE

Application Number

79137

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2017-12-29

Regulatory Status

RX

2024
07 Aug
Discontinued Application: 216137

Drug Name

VALBENAZINE TOSYLATE

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2024-08-07

216137 / 1

Active Ingredient

VALBENAZINE TOSYLATE

Application Number

216137

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2024-08-07

Regulatory Status

Discontinued

2024
07 Aug
Discontinued Application: 216137

Drug Name

VALBENAZINE TOSYLATE

Product Number

2

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2024-08-07

216137 / 2

Active Ingredient

VALBENAZINE TOSYLATE

Application Number

216137

Product Number

2

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2024-08-07

Regulatory Status

Discontinued

2024
07 Aug
Discontinued Application: 216137

Drug Name

VALBENAZINE TOSYLATE

Product Number

3

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2024-08-07

216137 / 3

Active Ingredient

VALBENAZINE TOSYLATE

Application Number

216137

Product Number

3

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2024-08-07

Regulatory Status

Discontinued

2024
22 Jul
RX Application: 218991

Drug Name

VALSARTAN

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2024-07-22

218991 / 1

Active Ingredient

VALSARTAN

Application Number

218991

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2024-07-22

Regulatory Status

RX

2024
22 Jul
RX Application: 218991

Drug Name

VALSARTAN

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2024-07-22

218991 / 2

Active Ingredient

VALSARTAN

Application Number

218991

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2024-07-22

Regulatory Status

RX

2024
22 Jul
RX Application: 218991

Drug Name

VALSARTAN

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2024-07-22

218991 / 3

Active Ingredient

VALSARTAN

Application Number

218991

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2024-07-22

Regulatory Status

RX

2024
22 Jul
RX Application: 218991

Drug Name

VALSARTAN

Product Number

4

Dosage Form

-

Strength

320MG

Approval Date

2024-07-22

218991 / 4

Active Ingredient

VALSARTAN

Application Number

218991

Product Number

4

Dosage Form

-

Strength

320MG

Approval Date

2024-07-22

Regulatory Status

RX

2019
15 Mar
Discontinued Application: 203000

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

2019-03-15

203000 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

203000

Product Number

1

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

2019-03-15

Regulatory Status

Discontinued

2019
15 Mar
Discontinued Application: 203000

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;160MG

Approval Date

2019-03-15

203000 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

203000

Product Number

2

Dosage Form

-

Strength

12.5MG;160MG

Approval Date

2019-03-15

Regulatory Status

Discontinued

2019
15 Mar
Discontinued Application: 203000

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

12.5MG;320MG

Approval Date

2019-03-15

203000 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

203000

Product Number

3

Dosage Form

-

Strength

12.5MG;320MG

Approval Date

2019-03-15

Regulatory Status

Discontinued

2019
15 Mar
Discontinued Application: 203000

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

4

Dosage Form

-

Strength

25MG;160MG

Approval Date

2019-03-15

203000 / 4

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

203000

Product Number

4

Dosage Form

-

Strength

25MG;160MG

Approval Date

2019-03-15

Regulatory Status

Discontinued

2019
15 Mar
Discontinued Application: 203000

Drug Name

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product Number

5

Dosage Form

-

Strength

25MG;320MG

Approval Date

2019-03-15

203000 / 5

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

203000

Product Number

5

Dosage Form

-

Strength

25MG;320MG

Approval Date

2019-03-15

Regulatory Status

Discontinued

2025
24 Nov
RX Application: 219252

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2025-11-24

219252 / 1

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

219252

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2025-11-24

Regulatory Status

RX

2025
24 Nov
RX Application: 219252

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2025-11-24

219252 / 2

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

219252

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2025-11-24

Regulatory Status

RX

2025
24 Nov
RX Application: 219252

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2025-11-24

219252 / 3

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

219252

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2025-11-24

Regulatory Status

RX

2023
02 Mar
Discontinued Application: 214671

Drug Name

VIGABATRIN

Product Number

1

Dosage Form

-

Strength

500MG/PACKET

Approval Date

2023-03-02

214671 / 1

Active Ingredient

VIGABATRIN

Application Number

214671

Product Number

1

Dosage Form

-

Strength

500MG/PACKET

Approval Date

2023-03-02

Regulatory Status

Discontinued

2022
19 Jan
RX Application: 215707

Drug Name

VIGABATRIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2022-01-19

215707 / 1

Active Ingredient

VIGABATRIN

Application Number

215707

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2022-01-19

Regulatory Status

RX

2016
24 May
RX Application: 206747

Drug Name

VORICONAZOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2016-05-24

206747 / 1

Active Ingredient

VORICONAZOLE

Application Number

206747

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2016-05-24

Regulatory Status

RX

2016
24 May
RX Application: 206747

Drug Name

VORICONAZOLE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2016-05-24

206747 / 2

Active Ingredient

VORICONAZOLE

Application Number

206747

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2016-05-24

Regulatory Status

RX

2017
22 Aug
RX Application: 208988

Drug Name

ZIPRASIDONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2017-08-22

208988 / 1

Active Ingredient

ZIPRASIDONE HYDROCHLORIDE

Application Number

208988

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2017-08-22

Regulatory Status

RX

2017
22 Aug
RX Application: 208988

Drug Name

ZIPRASIDONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2017-08-22

208988 / 2

Active Ingredient

ZIPRASIDONE HYDROCHLORIDE

Application Number

208988

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2017-08-22

Regulatory Status

RX

2017
22 Aug
RX Application: 208988

Drug Name

ZIPRASIDONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2017-08-22

208988 / 3

Active Ingredient

ZIPRASIDONE HYDROCHLORIDE

Application Number

208988

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2017-08-22

Regulatory Status

RX

2017
22 Aug
RX Application: 208988

Drug Name

ZIPRASIDONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2017-08-22

208988 / 4

Active Ingredient

ZIPRASIDONE HYDROCHLORIDE

Application Number

208988

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2017-08-22

Regulatory Status

RX

2023
03 Nov
RX Application: 216743

Drug Name

ZITUVIMET

Product Number

1

Dosage Form

-

Strength

500MG;50MG

Approval Date

2023-11-03

216743 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE; SITAGLIPTIN

Application Number

216743

Product Number

1

Dosage Form

-

Strength

500MG;50MG

Approval Date

2023-11-03

Regulatory Status

RX

2023
03 Nov
RX Application: 216743

Drug Name

ZITUVIMET

Product Number

2

Dosage Form

-

Strength

1GM;50MG

Approval Date

2023-11-03

216743 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE; SITAGLIPTIN

Application Number

216743

Product Number

2

Dosage Form

-

Strength

1GM;50MG

Approval Date

2023-11-03

Regulatory Status

RX

2024
18 Jul
RX Application: 216778

Drug Name

ZITUVIMET XR

Product Number

1

Dosage Form

-

Strength

500MG;50MG

Approval Date

2024-07-18

216778 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE; SITAGLIPTIN

Application Number

216778

Product Number

1

Dosage Form

-

Strength

500MG;50MG

Approval Date

2024-07-18

Regulatory Status

RX

2024
18 Jul
RX Application: 216778

Drug Name

ZITUVIMET XR

Product Number

2

Dosage Form

-

Strength

1GM;50MG

Approval Date

2024-07-18

216778 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE; SITAGLIPTIN

Application Number

216778

Product Number

2

Dosage Form

-

Strength

1GM;50MG

Approval Date

2024-07-18

Regulatory Status

RX

2024
18 Jul
RX Application: 216778

Drug Name

ZITUVIMET XR

Product Number

3

Dosage Form

-

Strength

1GM;100MG

Approval Date

2024-07-18

216778 / 3

Active Ingredient

METFORMIN HYDROCHLORIDE; SITAGLIPTIN

Application Number

216778

Product Number

3

Dosage Form

-

Strength

1GM;100MG

Approval Date

2024-07-18

Regulatory Status

RX

2023
18 Oct
RX Application: 211566

Drug Name

ZITUVIO

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2023-10-18

211566 / 1

Active Ingredient

SITAGLIPTIN

Application Number

211566

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2023-10-18

Regulatory Status

RX

2023
18 Oct
RX Application: 211566

Drug Name

ZITUVIO

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2023-10-18

211566 / 2

Active Ingredient

SITAGLIPTIN

Application Number

211566

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2023-10-18

Regulatory Status

RX

2023
18 Oct
RX Application: 211566

Drug Name

ZITUVIO

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2023-10-18

211566 / 3

Active Ingredient

SITAGLIPTIN

Application Number

211566

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2023-10-18

Regulatory Status

RX

2006
16 Oct
RX Application: 77625

Drug Name

ZONISAMIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2006-10-16

77625 / 1

Active Ingredient

ZONISAMIDE

Application Number

77625

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2006-10-16

Regulatory Status

RX

2006
16 Oct
RX Application: 77625

Drug Name

ZONISAMIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2006-10-16

77625 / 2

Active Ingredient

ZONISAMIDE

Application Number

77625

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2006-10-16

Regulatory Status

RX

2006
16 Oct
RX Application: 77625

Drug Name

ZONISAMIDE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2006-10-16

77625 / 3

Active Ingredient

ZONISAMIDE

Application Number

77625

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2006-10-16

Regulatory Status

RX

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Drug Status Breakdown
245 total
  • RX
  • Discontinued
  • Unclassified
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

ACETAZOLAMIDE

Application Number

205301

Product Number

1

Active Ingredient

ACETAZOLAMIDE

Dosage Form

-

Strength

500MG

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

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