Micro Labs Limited
FDA Approved Drugs

Micro Labs Limited

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 214
  • Latest Approval Date Jun 30, 2026
  • Data Source FDA
  • First Approval Date Feb 05, 1988
All
214
View
Unclassified
14
View
Discontinued
9
View
RX
191
View
Company Overview

Company

Micro Labs Limited

Country

India

Website

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Social Profiles

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Company Snapshot

Micro Labs Limited

27, RACE COURSE ROAD, BANGALORE-560 001

India

www.microlabsltd.com/ View on Map
FDA Approved Drug Records ( 214 records )
2020
01 Oct
RX Application: 207401

Drug Name

ACETAZOLAMIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2020-10-01

207401 / 1

Active Ingredient

ACETAZOLAMIDE

Application Number

207401

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2020-10-01

Regulatory Status

RX

2017
02 Nov
RX Application: 207435

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;20MG

Approval Date

2017-11-02

207435 / 1

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

207435

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;20MG

Approval Date

2017-11-02

Regulatory Status

RX

2017
02 Nov
RX Application: 207435

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;40MG

Approval Date

2017-11-02

207435 / 2

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

207435

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;40MG

Approval Date

2017-11-02

Regulatory Status

RX

2017
02 Nov
RX Application: 207435

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;20MG

Approval Date

2017-11-02

207435 / 3

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

207435

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;20MG

Approval Date

2017-11-02

Regulatory Status

RX

2017
02 Nov
RX Application: 207435

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;40MG

Approval Date

2017-11-02

207435 / 4

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

207435

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;40MG

Approval Date

2017-11-02

Regulatory Status

RX

2022
24 Jun
RX Application: 207471

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2022-06-24

207471 / 1

Active Ingredient

AMOXICILLIN

Application Number

207471

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2022-06-24

Regulatory Status

RX

2022
24 Jun
RX Application: 207471

Drug Name

AMOXICILLIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2022-06-24

207471 / 2

Active Ingredient

AMOXICILLIN

Application Number

207471

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2022-06-24

Regulatory Status

RX

2016
30 Dec
RX Application: 204755

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

3

Dosage Form

-

Strength

875MG;EQ 125MG BASE

Approval Date

2016-12-30

204755 / 3

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

204755

Product Number

3

Dosage Form

-

Strength

875MG;EQ 125MG BASE

Approval Date

2016-12-30

Regulatory Status

RX

2021
21 May
RX Application: 205187

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

1

Dosage Form

-

Strength

200MG/5ML;EQ 28.5MG BASE/5ML

Approval Date

2021-05-21

205187 / 1

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

205187

Product Number

1

Dosage Form

-

Strength

200MG/5ML;EQ 28.5MG BASE/5ML

Approval Date

2021-05-21

Regulatory Status

RX

2021
21 May
RX Application: 205187

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

2

Dosage Form

-

Strength

400MG/5ML;EQ 57MG BASE/5ML

Approval Date

2021-05-21

205187 / 2

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

205187

Product Number

2

Dosage Form

-

Strength

400MG/5ML;EQ 57MG BASE/5ML

Approval Date

2021-05-21

Regulatory Status

RX

2016
30 Dec
RX Application: 205707

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

1

Dosage Form

-

Strength

250MG;EQ 125MG BASE

Approval Date

2016-12-30

205707 / 1

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

205707

Product Number

1

Dosage Form

-

Strength

250MG;EQ 125MG BASE

Approval Date

2016-12-30

Regulatory Status

RX

2016
30 Dec
RX Application: 205707

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

2

Dosage Form

-

Strength

500MG;EQ 125MG BASE

Approval Date

2016-12-30

205707 / 2

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

205707

Product Number

2

Dosage Form

-

Strength

500MG;EQ 125MG BASE

Approval Date

2016-12-30

Regulatory Status

RX

2023
08 Dec
RX Application: 217805

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

1

Dosage Form

-

Strength

600MG/5ML;EQ 42.9MG BASE/5ML

Approval Date

2023-12-08

217805 / 1

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

217805

Product Number

1

Dosage Form

-

Strength

600MG/5ML;EQ 42.9MG BASE/5ML

Approval Date

2023-12-08

Regulatory Status

RX

2019
23 Dec
Discontinued Application: 210013

Drug Name

APIXABAN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2019-12-23

210013 / 1

Active Ingredient

APIXABAN

Application Number

210013

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2019-12-23

Regulatory Status

Discontinued

2019
23 Dec
Discontinued Application: 210013

Drug Name

APIXABAN

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-12-23

210013 / 2

Active Ingredient

APIXABAN

Application Number

210013

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-12-23

Regulatory Status

Discontinued

2025
07 Mar
RX Application: 218555

Drug Name

ARFORMOTEROL TARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 0.015MG BASE/2ML

Approval Date

2025-03-07

218555 / 1

Active Ingredient

ARFORMOTEROL TARTRATE

Application Number

218555

Product Number

1

Dosage Form

-

Strength

EQ 0.015MG BASE/2ML

Approval Date

2025-03-07

Regulatory Status

RX

2021
11 Aug
RX Application: 209929

Drug Name

ASPIRIN AND DIPYRIDAMOLE

Product Number

1

Dosage Form

-

Strength

25MG;200MG

Approval Date

2021-08-11

209929 / 1

Active Ingredient

ASPIRIN; DIPYRIDAMOLE

Application Number

209929

Product Number

1

Dosage Form

-

Strength

25MG;200MG

Approval Date

2021-08-11

Regulatory Status

RX

2019
07 Nov
RX Application: 205945

Drug Name

ATORVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2019-11-07

205945 / 1

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

205945

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2019-11-07

Regulatory Status

RX

2019
07 Nov
RX Application: 205945

Drug Name

ATORVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2019-11-07

205945 / 2

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

205945

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2019-11-07

Regulatory Status

RX

2019
07 Nov
RX Application: 205945

Drug Name

ATORVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2019-11-07

205945 / 3

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

205945

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2019-11-07

Regulatory Status

RX

2019
07 Nov
RX Application: 205945

Drug Name

ATORVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2019-11-07

205945 / 4

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

205945

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2019-11-07

Regulatory Status

RX

2023
08 Nov
RX Application: 217687

Drug Name

BACLOFEN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2023-11-08

217687 / 1

Active Ingredient

BACLOFEN

Application Number

217687

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2023-11-08

Regulatory Status

RX

2023
08 Nov
RX Application: 217687

Drug Name

BACLOFEN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2023-11-08

217687 / 2

Active Ingredient

BACLOFEN

Application Number

217687

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2023-11-08

Regulatory Status

RX

2023
08 Nov
RX Application: 217687

Drug Name

BACLOFEN

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2023-11-08

217687 / 3

Active Ingredient

BACLOFEN

Application Number

217687

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2023-11-08

Regulatory Status

RX

2020
08 Sep
RX Application: 202505

Drug Name

BIMATOPROST

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2020-09-08

202505 / 1

Active Ingredient

BIMATOPROST

Application Number

202505

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2020-09-08

Regulatory Status

RX

-
Unclassified Application: 204638

Drug Name

BIMATOPROST

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

-

204638 / 1

Active Ingredient

BIMATOPROST

Application Number

204638

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

-

Regulatory Status

Unclassified

2026
09 Mar
RX Application: 218303

Drug Name

BISOPROLOL FUMARATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2026-03-09

218303 / 1

Active Ingredient

BISOPROLOL FUMARATE

Application Number

218303

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2026-03-09

Regulatory Status

RX

2026
09 Mar
RX Application: 218303

Drug Name

BISOPROLOL FUMARATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-03-09

218303 / 2

Active Ingredient

BISOPROLOL FUMARATE

Application Number

218303

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-03-09

Regulatory Status

RX

2023
22 Nov
RX Application: 217846

Drug Name

BRIMONIDINE TARTRATE

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

2023-11-22

217846 / 1

Active Ingredient

BRIMONIDINE TARTRATE

Application Number

217846

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

2023-11-22

Regulatory Status

RX

2026
07 May
RX Application: 218558

Drug Name

BRIMONIDINE TARTRATE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2026-05-07

218558 / 1

Active Ingredient

BRIMONIDINE TARTRATE

Application Number

218558

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2026-05-07

Regulatory Status

RX

2026
23 Feb
RX Application: 214880

Drug Name

BRIVARACETAM

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2026-02-23

214880 / 1

Active Ingredient

BRIVARACETAM

Application Number

214880

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2026-02-23

Regulatory Status

RX

2020
17 Apr
RX Application: 207403

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2020-04-17

207403 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

207403

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2020-04-17

Regulatory Status

RX

2020
17 Apr
RX Application: 207403

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2020-04-17

207403 / 2

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

207403

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2020-04-17

Regulatory Status

RX

2017
14 Dec
RX Application: 207400

Drug Name

CAFFEINE CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

2017-12-14

207400 / 1

Active Ingredient

CAFFEINE CITRATE

Application Number

207400

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

2017-12-14

Regulatory Status

RX

2019
16 Dec
RX Application: 213202

Drug Name

CAFFEINE CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

2019-12-16

213202 / 1

Active Ingredient

CAFFEINE CITRATE

Application Number

213202

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

2019-12-16

Regulatory Status

RX

2024
03 Apr
RX Application: 218013

Drug Name

CARBOPROST TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/ML

Approval Date

2024-04-03

218013 / 1

Active Ingredient

CARBOPROST TROMETHAMINE

Application Number

218013

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/ML

Approval Date

2024-04-03

Regulatory Status

RX

2018
30 Apr
RX Application: 204776

Drug Name

CELECOXIB

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2018-04-30

204776 / 1

Active Ingredient

CELECOXIB

Application Number

204776

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2018-04-30

Regulatory Status

RX

2018
30 Apr
RX Application: 204776

Drug Name

CELECOXIB

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2018-04-30

204776 / 2

Active Ingredient

CELECOXIB

Application Number

204776

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2018-04-30

Regulatory Status

RX

2018
30 Apr
RX Application: 204776

Drug Name

CELECOXIB

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2018-04-30

204776 / 3

Active Ingredient

CELECOXIB

Application Number

204776

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2018-04-30

Regulatory Status

RX

2018
30 Apr
RX Application: 204776

Drug Name

CELECOXIB

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

2018-04-30

204776 / 4

Active Ingredient

CELECOXIB

Application Number

204776

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

2018-04-30

Regulatory Status

RX

2022
02 Feb
Discontinued Application: 211925

Drug Name

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE;5MG

Approval Date

2022-02-02

211925 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE

Application Number

211925

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE;5MG

Approval Date

2022-02-02

Regulatory Status

Discontinued

2022
02 Feb
Discontinued Application: 211925

Drug Name

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE;10MG

Approval Date

2022-02-02

211925 / 2

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE

Application Number

211925

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE;10MG

Approval Date

2022-02-02

Regulatory Status

Discontinued

2022
19 Jul
RX Application: 215835

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

5MG;2.5MG

Approval Date

2022-07-19

215835 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE

Application Number

215835

Product Number

1

Dosage Form

-

Strength

5MG;2.5MG

Approval Date

2022-07-19

Regulatory Status

RX

2026
05 Mar
RX Application: 219318

Drug Name

CHOLESTYRAMINE

Product Number

1

Dosage Form

-

Strength

EQ 4GM RESIN/PACKET

Approval Date

2026-03-05

219318 / 1

Active Ingredient

CHOLESTYRAMINE

Application Number

219318

Product Number

1

Dosage Form

-

Strength

EQ 4GM RESIN/PACKET

Approval Date

2026-03-05

Regulatory Status

RX

2018
05 Nov
RX Application: 207402

Drug Name

CLINDAMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2018-11-05

207402 / 1

Active Ingredient

CLINDAMYCIN HYDROCHLORIDE

Application Number

207402

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2018-11-05

Regulatory Status

RX

2018
05 Nov
RX Application: 207402

Drug Name

CLINDAMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2018-11-05

207402 / 2

Active Ingredient

CLINDAMYCIN HYDROCHLORIDE

Application Number

207402

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2018-11-05

Regulatory Status

RX

2018
05 Nov
RX Application: 207402

Drug Name

CLINDAMYCIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2018-11-05

207402 / 3

Active Ingredient

CLINDAMYCIN HYDROCHLORIDE

Application Number

207402

Product Number

3

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2018-11-05

Regulatory Status

RX

2019
30 Jan
RX Application: 211711

Drug Name

CLOBAZAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2019-01-30

211711 / 1

Active Ingredient

CLOBAZAM

Application Number

211711

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2019-01-30

Regulatory Status

RX

2019
30 Jan
RX Application: 211711

Drug Name

CLOBAZAM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2019-01-30

211711 / 2

Active Ingredient

CLOBAZAM

Application Number

211711

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2019-01-30

Regulatory Status

RX

2020
22 Jun
RX Application: 213219

Drug Name

CLOMIPRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2020-06-22

213219 / 1

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

213219

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2020-06-22

Regulatory Status

RX

2020
22 Jun
RX Application: 213219

Drug Name

CLOMIPRAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2020-06-22

213219 / 2

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

213219

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2020-06-22

Regulatory Status

RX

2020
22 Jun
RX Application: 213219

Drug Name

CLOMIPRAMINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2020-06-22

213219 / 3

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

213219

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2020-06-22

Regulatory Status

RX

2026
17 Feb
RX Application: 212880

Drug Name

COLCHICINE

Product Number

1

Dosage Form

-

Strength

0.6MG

Approval Date

2026-02-17

212880 / 1

Active Ingredient

COLCHICINE

Application Number

212880

Product Number

1

Dosage Form

-

Strength

0.6MG

Approval Date

2026-02-17

Regulatory Status

RX

2013
04 Apr
RX Application: 202745

Drug Name

CROMOLYN SODIUM

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2013-04-04

202745 / 1

Active Ingredient

CROMOLYN SODIUM

Application Number

202745

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2013-04-04

Regulatory Status

RX

2022
29 Apr
RX Application: 213658

Drug Name

CROMOLYN SODIUM

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2022-04-29

213658 / 1

Active Ingredient

CROMOLYN SODIUM

Application Number

213658

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2022-04-29

Regulatory Status

RX

2019
11 Mar
RX Application: 210158

Drug Name

DALFAMPRIDINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2019-03-11

210158 / 1

Active Ingredient

DALFAMPRIDINE

Application Number

210158

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2019-03-11

Regulatory Status

RX

2026
06 Apr
RX Application: 211467

Drug Name

DAPAGLIFLOZIN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2026-04-06

211467 / 1

Active Ingredient

DAPAGLIFLOZIN

Application Number

211467

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211467

Drug Name

DAPAGLIFLOZIN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-04-06

211467 / 2

Active Ingredient

DAPAGLIFLOZIN

Application Number

211467

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211466

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG;500MG

Approval Date

2026-04-06

211466 / 1

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211466

Product Number

1

Dosage Form

-

Strength

5MG;500MG

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211466

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG;1GM

Approval Date

2026-04-06

211466 / 2

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211466

Product Number

2

Dosage Form

-

Strength

5MG;1GM

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211466

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG;500MG

Approval Date

2026-04-06

211466 / 3

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211466

Product Number

3

Dosage Form

-

Strength

10MG;500MG

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211466

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

10MG;1GM

Approval Date

2026-04-06

211466 / 4

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211466

Product Number

4

Dosage Form

-

Strength

10MG;1GM

Approval Date

2026-04-06

Regulatory Status

RX

2024
27 Mar
RX Application: 217797

Drug Name

DEXAMETHASONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG PHOSPHATE/ML

Approval Date

2024-03-27

217797 / 1

Active Ingredient

DEXAMETHASONE SODIUM PHOSPHATE

Application Number

217797

Product Number

1

Dosage Form

-

Strength

EQ 10MG PHOSPHATE/ML

Approval Date

2024-03-27

Regulatory Status

RX

1999
26 Feb
Discontinued Application: 74986

Drug Name

DICLOFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1999-02-26

74986 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

74986

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1999-02-26

Regulatory Status

Discontinued

1999
26 Feb
Discontinued Application: 74986

Drug Name

DICLOFENAC SODIUM

Product Number

2

Dosage Form

-

Strength

75MG

Approval Date

1999-02-26

74986 / 2

Active Ingredient

DICLOFENAC SODIUM

Application Number

74986

Product Number

2

Dosage Form

-

Strength

75MG

Approval Date

1999-02-26

Regulatory Status

Discontinued

2021
15 Jul
RX Application: 204355

Drug Name

DICLOFENAC SODIUM AND MISOPROSTOL

Product Number

1

Dosage Form

-

Strength

50MG;0.2MG

Approval Date

2021-07-15

204355 / 1

Active Ingredient

DICLOFENAC SODIUM; MISOPROSTOL

Application Number

204355

Product Number

1

Dosage Form

-

Strength

50MG;0.2MG

Approval Date

2021-07-15

Regulatory Status

RX

2021
15 Jul
RX Application: 204355

Drug Name

DICLOFENAC SODIUM AND MISOPROSTOL

Product Number

2

Dosage Form

-

Strength

75MG;0.2MG

Approval Date

2021-07-15

204355 / 2

Active Ingredient

DICLOFENAC SODIUM; MISOPROSTOL

Application Number

204355

Product Number

2

Dosage Form

-

Strength

75MG;0.2MG

Approval Date

2021-07-15

Regulatory Status

RX

2018
22 Aug
RX Application: 205723

Drug Name

DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2018-08-22

205723 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

205723

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2018-08-22

Regulatory Status

RX

2025
22 Aug
RX Application: 219845

Drug Name

DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2025-08-22

219845 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

219845

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2025-08-22

Regulatory Status

RX

-
Unclassified Application: 212179

Drug Name

DOLUTEGRAVIR SODIUM

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

212179 / 1

Active Ingredient

DOLUTEGRAVIR SODIUM

Application Number

212179

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

2019
08 Nov
RX Application: 204778

Drug Name

DORZOLAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE

Approval Date

2019-11-08

204778 / 1

Active Ingredient

DORZOLAMIDE HYDROCHLORIDE

Application Number

204778

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE

Approval Date

2019-11-08

Regulatory Status

RX

2020
28 May
RX Application: 204777

Drug Name

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2020-05-28

204777 / 1

Active Ingredient

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

Application Number

204777

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2020-05-28

Regulatory Status

RX

2022
25 Jan
RX Application: 215936

Drug Name

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2022-01-25

215936 / 1

Active Ingredient

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

Application Number

215936

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2022-01-25

Regulatory Status

RX

2023
27 Jun
RX Application: 217688

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2023-06-27

217688 / 1

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

217688

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2023-06-27

Regulatory Status

RX

2023
27 Jun
RX Application: 217688

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2023-06-27

217688 / 2

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

217688

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2023-06-27

Regulatory Status

RX

2023
27 Jun
RX Application: 217688

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2023-06-27

217688 / 3

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

217688

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2023-06-27

Regulatory Status

RX

2023
27 Jun
RX Application: 217688

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2023-06-27

217688 / 4

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

217688

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2023-06-27

Regulatory Status

RX

2023
27 Jun
RX Application: 217688

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2023-06-27

217688 / 5

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

217688

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2023-06-27

Regulatory Status

RX

-
Unclassified Application: 202042

Drug Name

EFAVIRENZ

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

202042 / 1

Active Ingredient

EFAVIRENZ

Application Number

202042

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 202042

Drug Name

EFAVIRENZ

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

-

202042 / 2

Active Ingredient

EFAVIRENZ

Application Number

202042

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 202301

Drug Name

EFAVIRENZ

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

-

202301 / 1

Active Ingredient

EFAVIRENZ

Application Number

202301

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 205389

Drug Name

EFAVIRENZ

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

205389 / 1

Active Ingredient

EFAVIRENZ

Application Number

205389

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 205389

Drug Name

EFAVIRENZ

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

205389 / 2

Active Ingredient

EFAVIRENZ

Application Number

205389

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 205389

Drug Name

EFAVIRENZ

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

-

205389 / 3

Active Ingredient

EFAVIRENZ

Application Number

205389

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

-

Regulatory Status

Unclassified

1988
05 Feb
RX Application: 62687

Drug Name

ERYTHRA-DERM

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1988-02-05

62687 / 1

Active Ingredient

ERYTHROMYCIN

Application Number

62687

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1988-02-05

Regulatory Status

RX

2026
22 Apr
RX Application: 91655

Drug Name

ESCITALOPRAM OXALATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2026-04-22

91655 / 1

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

91655

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2026-04-22

Regulatory Status

RX

2026
22 Apr
RX Application: 91655

Drug Name

ESCITALOPRAM OXALATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2026-04-22

91655 / 2

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

91655

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2026-04-22

Regulatory Status

RX

2026
22 Apr
RX Application: 91655

Drug Name

ESCITALOPRAM OXALATE

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2026-04-22

91655 / 3

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

91655

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2026-04-22

Regulatory Status

RX

2023
14 Sep
RX Application: 217842

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

2023-09-14

217842 / 1

Active Ingredient

FAMOTIDINE

Application Number

217842

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

2023-09-14

Regulatory Status

RX

2020
16 Jun
RX Application: 213450

Drug Name

FENOFIBRIC ACID

Product Number

1

Dosage Form

-

Strength

EQ 45MG FENOFIBRIC ACID

Approval Date

2020-06-16

213450 / 1

Active Ingredient

CHOLINE FENOFIBRATE

Application Number

213450

Product Number

1

Dosage Form

-

Strength

EQ 45MG FENOFIBRIC ACID

Approval Date

2020-06-16

Regulatory Status

RX

2020
16 Jun
RX Application: 213450

Drug Name

FENOFIBRIC ACID

Product Number

2

Dosage Form

-

Strength

EQ 135MG FENOFIBRIC ACID

Approval Date

2020-06-16

213450 / 2

Active Ingredient

CHOLINE FENOFIBRATE

Application Number

213450

Product Number

2

Dosage Form

-

Strength

EQ 135MG FENOFIBRIC ACID

Approval Date

2020-06-16

Regulatory Status

RX

2022
29 Mar
RX Application: 216232

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2022-03-29

216232 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

216232

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2022-03-29

Regulatory Status

RX

2022
29 Mar
RX Application: 216232

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2022-03-29

216232 / 2

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

216232

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2022-03-29

Regulatory Status

RX

2022
29 Mar
RX Application: 216232

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2022-03-29

216232 / 3

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

216232

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2022-03-29

Regulatory Status

RX

2026
23 Jun
RX Application: 220768

Drug Name

FLUVOXAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2026-06-23

220768 / 1

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

220768

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2026-06-23

Regulatory Status

RX

2026
23 Jun
RX Application: 220768

Drug Name

FLUVOXAMINE MALEATE

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2026-06-23

220768 / 2

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

220768

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2026-06-23

Regulatory Status

RX

2024
26 Jun
RX Application: 218304

Drug Name

FORMOTEROL FUMARATE

Product Number

1

Dosage Form

-

Strength

0.02MG/2ML

Approval Date

2024-06-26

218304 / 1

Active Ingredient

FORMOTEROL FUMARATE

Application Number

218304

Product Number

1

Dosage Form

-

Strength

0.02MG/2ML

Approval Date

2024-06-26

Regulatory Status

RX

2026
08 Jan
RX Application: 218188

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2026-01-08

218188 / 1

Active Ingredient

FUROSEMIDE

Application Number

218188

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2026-01-08

Regulatory Status

RX

2012
29 Jun
RX Application: 91220

Drug Name

GLIMEPIRIDE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2012-06-29

91220 / 1

Active Ingredient

GLIMEPIRIDE

Application Number

91220

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2012-06-29

Regulatory Status

RX

2012
29 Jun
RX Application: 91220

Drug Name

GLIMEPIRIDE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2012-06-29

91220 / 2

Active Ingredient

GLIMEPIRIDE

Application Number

91220

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2012-06-29

Regulatory Status

RX

2012
29 Jun
RX Application: 91220

Drug Name

GLIMEPIRIDE

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2012-06-29

91220 / 3

Active Ingredient

GLIMEPIRIDE

Application Number

91220

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2012-06-29

Regulatory Status

RX

2012
29 Jun
RX Application: 91220

Drug Name

GLIMEPIRIDE

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

2012-06-29

91220 / 4

Active Ingredient

GLIMEPIRIDE

Application Number

91220

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

2012-06-29

Regulatory Status

RX

2012
29 Jun
RX Application: 91220

Drug Name

GLIMEPIRIDE

Product Number

5

Dosage Form

-

Strength

6MG

Approval Date

2012-06-29

91220 / 5

Active Ingredient

GLIMEPIRIDE

Application Number

91220

Product Number

5

Dosage Form

-

Strength

6MG

Approval Date

2012-06-29

Regulatory Status

RX

2012
29 Jun
RX Application: 91220

Drug Name

GLIMEPIRIDE

Product Number

6

Dosage Form

-

Strength

8MG

Approval Date

2012-06-29

91220 / 6

Active Ingredient

GLIMEPIRIDE

Application Number

91220

Product Number

6

Dosage Form

-

Strength

8MG

Approval Date

2012-06-29

Regulatory Status

RX

2021
16 Feb
RX Application: 210845

Drug Name

ISOPROTERENOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2021-02-16

210845 / 1

Active Ingredient

ISOPROTERENOL HYDROCHLORIDE

Application Number

210845

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2021-02-16

Regulatory Status

RX

2019
05 Apr
RX Application: 203410

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2019-04-05

203410 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

203410

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2019-04-05

Regulatory Status

RX

-
Unclassified Application: 200406

Drug Name

LAMIVUDINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

-

200406 / 1

Active Ingredient

LAMIVUDINE

Application Number

200406

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 200406

Drug Name

LAMIVUDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

-

200406 / 2

Active Ingredient

LAMIVUDINE

Application Number

200406

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

-

Regulatory Status

Unclassified

2018
13 Aug
Discontinued Application: 205626

Drug Name

LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE

Product Number

1

Dosage Form

-

Strength

150MG;200MG;300MG

Approval Date

2018-08-13

205626 / 1

Active Ingredient

LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE

Application Number

205626

Product Number

1

Dosage Form

-

Strength

150MG;200MG;300MG

Approval Date

2018-08-13

Regulatory Status

Discontinued

2025
14 Apr
RX Application: 219306

Drug Name

LATANOPROST

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2025-04-14

219306 / 1

Active Ingredient

LATANOPROST

Application Number

219306

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2025-04-14

Regulatory Status

RX

2019
09 Aug
RX Application: 211954

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2019-08-09

211954 / 1

Active Ingredient

LEVETIRACETAM

Application Number

211954

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2019-08-09

Regulatory Status

RX

2013
17 Sep
RX Application: 202046

Drug Name

LEVOCETIRIZINE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2013-09-17

202046 / 1

Active Ingredient

LEVOCETIRIZINE DIHYDROCHLORIDE

Application Number

202046

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2013-09-17

Regulatory Status

RX

2019
27 Feb
RX Application: 205600

Drug Name

LEVOFLOXACIN

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

2019-02-27

205600 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

205600

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

2019-02-27

Regulatory Status

RX

2023
04 Aug
Discontinued Application: 215081

Drug Name

LIFITEGRAST

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2023-08-04

215081 / 1

Active Ingredient

LIFITEGRAST

Application Number

215081

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2023-08-04

Regulatory Status

Discontinued

2021
08 Nov
RX Application: 215082

Drug Name

LINCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/ML

Approval Date

2021-11-08

215082 / 1

Active Ingredient

LINCOMYCIN HYDROCHLORIDE

Application Number

215082

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/ML

Approval Date

2021-11-08

Regulatory Status

RX

2025
11 Dec
RX Application: 214696

Drug Name

LOPINAVIR AND RITONAVIR

Product Number

1

Dosage Form

-

Strength

100MG;25MG

Approval Date

2025-12-11

214696 / 1

Active Ingredient

LOPINAVIR; RITONAVIR

Application Number

214696

Product Number

1

Dosage Form

-

Strength

100MG;25MG

Approval Date

2025-12-11

Regulatory Status

RX

2025
11 Dec
RX Application: 214696

Drug Name

LOPINAVIR AND RITONAVIR

Product Number

2

Dosage Form

-

Strength

200MG;50MG

Approval Date

2025-12-11

214696 / 2

Active Ingredient

LOPINAVIR; RITONAVIR

Application Number

214696

Product Number

2

Dosage Form

-

Strength

200MG;50MG

Approval Date

2025-12-11

Regulatory Status

RX

2012
24 Sep
RX Application: 91541

Drug Name

LOSARTAN POTASSIUM

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2012-09-24

91541 / 1

Active Ingredient

LOSARTAN POTASSIUM

Application Number

91541

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2012-09-24

Regulatory Status

RX

2012
24 Sep
RX Application: 91541

Drug Name

LOSARTAN POTASSIUM

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2012-09-24

91541 / 2

Active Ingredient

LOSARTAN POTASSIUM

Application Number

91541

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2012-09-24

Regulatory Status

RX

2012
24 Sep
RX Application: 91541

Drug Name

LOSARTAN POTASSIUM

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2012-09-24

91541 / 3

Active Ingredient

LOSARTAN POTASSIUM

Application Number

91541

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2012-09-24

Regulatory Status

RX

2010
19 Nov
RX Application: 90562

Drug Name

MEFENAMIC ACID

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2010-11-19

90562 / 1

Active Ingredient

MEFENAMIC ACID

Application Number

90562

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2010-11-19

Regulatory Status

RX

2023
10 Jan
RX Application: 212448

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2023-01-10

212448 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

212448

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2023-01-10

Regulatory Status

RX

2023
10 Jan
RX Application: 212448

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2023-01-10

212448 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

212448

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2023-01-10

Regulatory Status

RX

2019
01 Aug
RX Application: 212172

Drug Name

METHENAMINE HIPPURATE

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2019-08-01

212172 / 1

Active Ingredient

METHENAMINE HIPPURATE

Application Number

212172

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2019-08-01

Regulatory Status

RX

2024
06 Nov
RX Application: 217563

Drug Name

METOLAZONE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2024-11-06

217563 / 1

Active Ingredient

METOLAZONE

Application Number

217563

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2024-11-06

Regulatory Status

RX

2024
06 Nov
RX Application: 217563

Drug Name

METOLAZONE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2024-11-06

217563 / 2

Active Ingredient

METOLAZONE

Application Number

217563

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2024-11-06

Regulatory Status

RX

2024
06 Nov
RX Application: 217563

Drug Name

METOLAZONE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2024-11-06

217563 / 3

Active Ingredient

METOLAZONE

Application Number

217563

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2024-11-06

Regulatory Status

RX

2023
21 Aug
RX Application: 217504

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2023-08-21

217504 / 1

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

217504

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2023-08-21

Regulatory Status

RX

2023
21 Aug
RX Application: 217504

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2023-08-21

217504 / 2

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

217504

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2023-08-21

Regulatory Status

RX

2026
19 May
RX Application: 220104

Drug Name

MIRTAZAPINE

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2026-05-19

220104 / 1

Active Ingredient

MIRTAZAPINE

Application Number

220104

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2026-05-19

Regulatory Status

RX

2026
19 May
RX Application: 220104

Drug Name

MIRTAZAPINE

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2026-05-19

220104 / 2

Active Ingredient

MIRTAZAPINE

Application Number

220104

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2026-05-19

Regulatory Status

RX

2026
19 May
RX Application: 220104

Drug Name

MIRTAZAPINE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2026-05-19

220104 / 3

Active Ingredient

MIRTAZAPINE

Application Number

220104

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2026-05-19

Regulatory Status

RX

2026
19 May
RX Application: 220104

Drug Name

MIRTAZAPINE

Product Number

4

Dosage Form

-

Strength

45MG

Approval Date

2026-05-19

220104 / 4

Active Ingredient

MIRTAZAPINE

Application Number

220104

Product Number

4

Dosage Form

-

Strength

45MG

Approval Date

2026-05-19

Regulatory Status

RX

2022
17 Oct
RX Application: 216872

Drug Name

MISOPROSTOL

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2022-10-17

216872 / 1

Active Ingredient

MISOPROSTOL

Application Number

216872

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2022-10-17

Regulatory Status

RX

2022
17 Oct
RX Application: 216872

Drug Name

MISOPROSTOL

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2022-10-17

216872 / 2

Active Ingredient

MISOPROSTOL

Application Number

216872

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2022-10-17

Regulatory Status

RX

-
Unclassified Application: 206729

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

-

206729 / 1

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

206729

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 206729

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

-

206729 / 2

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

206729

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 206729

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

-

206729 / 3

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

206729

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 206729

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

-

206729 / 4

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

206729

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

-

Regulatory Status

Unclassified

2012
22 May
RX Application: 203080

Drug Name

NEVIRAPINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2012-05-22

203080 / 1

Active Ingredient

NEVIRAPINE

Application Number

203080

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2012-05-22

Regulatory Status

RX

2023
07 Jul
RX Application: 216420

Drug Name

NICARDIPINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/10ML (2.5MG/ML)

Approval Date

2023-07-07

216420 / 1

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

216420

Product Number

1

Dosage Form

-

Strength

25MG/10ML (2.5MG/ML)

Approval Date

2023-07-07

Regulatory Status

RX

2026
08 Apr
RX Application: 218557

Drug Name

OFLOXACIN

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2026-04-08

218557 / 1

Active Ingredient

OFLOXACIN

Application Number

218557

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2026-04-08

Regulatory Status

RX

2019
17 Sep
RX Application: 206372

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-09-17

206372 / 1

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

206372

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-09-17

Regulatory Status

RX

2019
17 Sep
RX Application: 206372

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2019-09-17

206372 / 2

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

206372

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2019-09-17

Regulatory Status

RX

2019
17 Sep
RX Application: 206372

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2019-09-17

206372 / 3

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

206372

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2019-09-17

Regulatory Status

RX

2026
13 Apr
RX Application: 206371

Drug Name

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2026-04-13

206371 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

206371

Product Number

1

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2026-04-13

Regulatory Status

RX

2026
13 Apr
RX Application: 206371

Drug Name

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;40MG

Approval Date

2026-04-13

206371 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

206371

Product Number

2

Dosage Form

-

Strength

12.5MG;40MG

Approval Date

2026-04-13

Regulatory Status

RX

2026
13 Apr
RX Application: 206371

Drug Name

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;40MG

Approval Date

2026-04-13

206371 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

206371

Product Number

3

Dosage Form

-

Strength

25MG;40MG

Approval Date

2026-04-13

Regulatory Status

RX

2025
24 Nov
RX Application: 207437

Drug Name

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;12.5MG;20MG

Approval Date

2025-11-24

207437 / 1

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

207437

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;12.5MG;20MG

Approval Date

2025-11-24

Regulatory Status

RX

2025
24 Nov
RX Application: 207437

Drug Name

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;12.5MG;40MG

Approval Date

2025-11-24

207437 / 2

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

207437

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;12.5MG;40MG

Approval Date

2025-11-24

Regulatory Status

RX

2025
24 Nov
RX Application: 207437

Drug Name

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;25MG;40MG

Approval Date

2025-11-24

207437 / 3

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

207437

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;25MG;40MG

Approval Date

2025-11-24

Regulatory Status

RX

2025
24 Nov
RX Application: 207437

Drug Name

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;12.5MG;40MG

Approval Date

2025-11-24

207437 / 4

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

207437

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;12.5MG;40MG

Approval Date

2025-11-24

Regulatory Status

RX

2025
24 Nov
RX Application: 207437

Drug Name

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE

Product Number

5

Dosage Form

-

Strength

EQ 10MG BASE;25MG;40MG

Approval Date

2025-11-24

207437 / 5

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

207437

Product Number

5

Dosage Form

-

Strength

EQ 10MG BASE;25MG;40MG

Approval Date

2025-11-24

Regulatory Status

RX

2022
18 May
RX Application: 212680

Drug Name

PIRFENIDONE

Product Number

1

Dosage Form

-

Strength

267MG

Approval Date

2022-05-18

212680 / 1

Active Ingredient

PIRFENIDONE

Application Number

212680

Product Number

1

Dosage Form

-

Strength

267MG

Approval Date

2022-05-18

Regulatory Status

RX

2022
18 May
RX Application: 212680

Drug Name

PIRFENIDONE

Product Number

2

Dosage Form

-

Strength

801MG

Approval Date

2022-05-18

212680 / 2

Active Ingredient

PIRFENIDONE

Application Number

212680

Product Number

2

Dosage Form

-

Strength

801MG

Approval Date

2022-05-18

Regulatory Status

RX

2017
29 Dec
RX Application: 206152

Drug Name

PIROXICAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-12-29

206152 / 1

Active Ingredient

PIROXICAM

Application Number

206152

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-12-29

Regulatory Status

RX

2017
29 Dec
RX Application: 206152

Drug Name

PIROXICAM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2017-12-29

206152 / 2

Active Ingredient

PIROXICAM

Application Number

206152

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2017-12-29

Regulatory Status

RX

2025
20 Oct
RX Application: 219294

Drug Name

PROPARACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2025-10-20

219294 / 1

Active Ingredient

PROPARACAINE HYDROCHLORIDE

Application Number

219294

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2025-10-20

Regulatory Status

RX

2026
24 Jun
RX Application: 217238

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2026-06-24

217238 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

217238

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2026-06-24

Regulatory Status

RX

2026
24 Jun
RX Application: 217238

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2026-06-24

217238 / 2

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

217238

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2026-06-24

Regulatory Status

RX

2026
24 Jun
RX Application: 217238

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

2026-06-24

217238 / 3

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

217238

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

2026-06-24

Regulatory Status

RX

2026
24 Jun
RX Application: 217238

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

160MG

Approval Date

2026-06-24

217238 / 4

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

217238

Product Number

4

Dosage Form

-

Strength

160MG

Approval Date

2026-06-24

Regulatory Status

RX

2026
29 Jun
RX Application: 219180

Drug Name

PRUCALOPRIDE SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2026-06-29

219180 / 1

Active Ingredient

PRUCALOPRIDE SUCCINATE

Application Number

219180

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2026-06-29

Regulatory Status

RX

2026
29 Jun
RX Application: 219180

Drug Name

PRUCALOPRIDE SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2026-06-29

219180 / 2

Active Ingredient

PRUCALOPRIDE SUCCINATE

Application Number

219180

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2026-06-29

Regulatory Status

RX

2023
09 Feb
RX Application: 215243

Drug Name

RAMELTEON

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

2023-02-09

215243 / 1

Active Ingredient

RAMELTEON

Application Number

215243

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

2023-02-09

Regulatory Status

RX

2020
27 Feb
RX Application: 211745

Drug Name

RANOLAZINE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2020-02-27

211745 / 1

Active Ingredient

RANOLAZINE

Application Number

211745

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2020-02-27

Regulatory Status

RX

2020
27 Feb
RX Application: 211745

Drug Name

RANOLAZINE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2020-02-27

211745 / 2

Active Ingredient

RANOLAZINE

Application Number

211745

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2020-02-27

Regulatory Status

RX

2019
29 Mar
RX Application: 207004

Drug Name

RASAGILINE MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2019-03-29

207004 / 1

Active Ingredient

RASAGILINE MESYLATE

Application Number

207004

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2019-03-29

Regulatory Status

RX

2019
29 Mar
RX Application: 207004

Drug Name

RASAGILINE MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2019-03-29

207004 / 2

Active Ingredient

RASAGILINE MESYLATE

Application Number

207004

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2019-03-29

Regulatory Status

RX

2026
30 Jun
RX Application: 208334

Drug Name

RIVAROXABAN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2026-06-30

208334 / 1

Active Ingredient

RIVAROXABAN

Application Number

208334

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2026-06-30

Regulatory Status

RX

2026
30 Jun
RX Application: 208334

Drug Name

RIVAROXABAN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-06-30

208334 / 2

Active Ingredient

RIVAROXABAN

Application Number

208334

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-06-30

Regulatory Status

RX

2026
30 Jun
RX Application: 208334

Drug Name

RIVAROXABAN

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2026-06-30

208334 / 3

Active Ingredient

RIVAROXABAN

Application Number

208334

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2026-06-30

Regulatory Status

RX

2026
30 Jun
RX Application: 208334

Drug Name

RIVAROXABAN

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2026-06-30

208334 / 4

Active Ingredient

RIVAROXABAN

Application Number

208334

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2026-06-30

Regulatory Status

RX

2019
22 Mar
RX Application: 208180

Drug Name

ROFLUMILAST

Product Number

1

Dosage Form

-

Strength

500MCG

Approval Date

2019-03-22

208180 / 1

Active Ingredient

ROFLUMILAST

Application Number

208180

Product Number

1

Dosage Form

-

Strength

500MCG

Approval Date

2019-03-22

Regulatory Status

RX

2023
18 Apr
RX Application: 208180

Drug Name

ROFLUMILAST

Product Number

2

Dosage Form

-

Strength

250MCG

Approval Date

2023-04-18

208180 / 2

Active Ingredient

ROFLUMILAST

Application Number

208180

Product Number

2

Dosage Form

-

Strength

250MCG

Approval Date

2023-04-18

Regulatory Status

RX

2023
15 May
RX Application: 216688

Drug Name

RUFINAMIDE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2023-05-15

216688 / 1

Active Ingredient

RUFINAMIDE

Application Number

216688

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2023-05-15

Regulatory Status

RX

2023
15 May
RX Application: 216688

Drug Name

RUFINAMIDE

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2023-05-15

216688 / 2

Active Ingredient

RUFINAMIDE

Application Number

216688

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2023-05-15

Regulatory Status

RX

2026
08 Jan
RX Application: 219511

Drug Name

SAPROPTERIN DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/PACKET

Approval Date

2026-01-08

219511 / 1

Active Ingredient

SAPROPTERIN DIHYDROCHLORIDE

Application Number

219511

Product Number

1

Dosage Form

-

Strength

100MG/PACKET

Approval Date

2026-01-08

Regulatory Status

RX

2026
08 Jan
RX Application: 219511

Drug Name

SAPROPTERIN DIHYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

500MG/PACKET

Approval Date

2026-01-08

219511 / 2

Active Ingredient

SAPROPTERIN DIHYDROCHLORIDE

Application Number

219511

Product Number

2

Dosage Form

-

Strength

500MG/PACKET

Approval Date

2026-01-08

Regulatory Status

RX

2022
07 Feb
RX Application: 215537

Drug Name

SEVELAMER CARBONATE

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

2022-02-07

215537 / 1

Active Ingredient

SEVELAMER CARBONATE

Application Number

215537

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

2022-02-07

Regulatory Status

RX

2011
16 Sep
RX Application: 90383

Drug Name

SIMVASTATIN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-09-16

90383 / 1

Active Ingredient

SIMVASTATIN

Application Number

90383

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-09-16

Regulatory Status

RX

2011
16 Sep
RX Application: 90383

Drug Name

SIMVASTATIN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-09-16

90383 / 2

Active Ingredient

SIMVASTATIN

Application Number

90383

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-09-16

Regulatory Status

RX

2011
16 Sep
RX Application: 90383

Drug Name

SIMVASTATIN

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2011-09-16

90383 / 3

Active Ingredient

SIMVASTATIN

Application Number

90383

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2011-09-16

Regulatory Status

RX

2011
16 Sep
RX Application: 90383

Drug Name

SIMVASTATIN

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2011-09-16

90383 / 4

Active Ingredient

SIMVASTATIN

Application Number

90383

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2011-09-16

Regulatory Status

RX

2011
16 Sep
RX Application: 90383

Drug Name

SIMVASTATIN

Product Number

5

Dosage Form

-

Strength

80MG

Approval Date

2011-09-16

90383 / 5

Active Ingredient

SIMVASTATIN

Application Number

90383

Product Number

5

Dosage Form

-

Strength

80MG

Approval Date

2011-09-16

Regulatory Status

RX

2017
08 Dec
RX Application: 209352

Drug Name

SODIUM NITROPRUSSIDE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2017-12-08

209352 / 1

Active Ingredient

SODIUM NITROPRUSSIDE

Application Number

209352

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2017-12-08

Regulatory Status

RX

2020
24 Nov
RX Application: 214879

Drug Name

SUCCINYLCHOLINE CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2020-11-24

214879 / 1

Active Ingredient

SUCCINYLCHOLINE CHLORIDE

Application Number

214879

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2020-11-24

Regulatory Status

RX

2019
19 Aug
RX Application: 209051

Drug Name

TAFLUPROST

Product Number

1

Dosage Form

-

Strength

0.0015%

Approval Date

2019-08-19

209051 / 1

Active Ingredient

TAFLUPROST

Application Number

209051

Product Number

1

Dosage Form

-

Strength

0.0015%

Approval Date

2019-08-19

Regulatory Status

RX

2017
03 Oct
RX Application: 207016

Drug Name

TELMISARTAN

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2017-10-03

207016 / 1

Active Ingredient

TELMISARTAN

Application Number

207016

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2017-10-03

Regulatory Status

RX

2017
03 Oct
RX Application: 207016

Drug Name

TELMISARTAN

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2017-10-03

207016 / 2

Active Ingredient

TELMISARTAN

Application Number

207016

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2017-10-03

Regulatory Status

RX

2017
03 Oct
RX Application: 207016

Drug Name

TELMISARTAN

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2017-10-03

207016 / 3

Active Ingredient

TELMISARTAN

Application Number

207016

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2017-10-03

Regulatory Status

RX

2025
18 Dec
RX Application: 206157

Drug Name

TENOFOVIR DISOPROXIL FUMARATE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2025-12-18

206157 / 1

Active Ingredient

TENOFOVIR DISOPROXIL FUMARATE

Application Number

206157

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2025-12-18

Regulatory Status

RX

2026
27 Apr
RX Application: 208539

Drug Name

TICAGRELOR

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2026-04-27

208539 / 1

Active Ingredient

TICAGRELOR

Application Number

208539

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2026-04-27

Regulatory Status

RX

2026
27 Apr
RX Application: 208539

Drug Name

TICAGRELOR

Product Number

2

Dosage Form

-

Strength

90MG

Approval Date

2026-04-27

208539 / 2

Active Ingredient

TICAGRELOR

Application Number

208539

Product Number

2

Dosage Form

-

Strength

90MG

Approval Date

2026-04-27

Regulatory Status

RX

2022
07 Sep
RX Application: 216596

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2022-09-07

216596 / 1

Active Ingredient

TIMOLOL MALEATE

Application Number

216596

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2022-09-07

Regulatory Status

RX

2023
26 May
RX Application: 217343

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 0.25% BASE

Approval Date

2023-05-26

217343 / 1

Active Ingredient

TIMOLOL MALEATE

Application Number

217343

Product Number

1

Dosage Form

-

Strength

EQ 0.25% BASE

Approval Date

2023-05-26

Regulatory Status

RX

2023
26 May
RX Application: 217343

Drug Name

TIMOLOL MALEATE

Product Number

2

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2023-05-26

217343 / 2

Active Ingredient

TIMOLOL MALEATE

Application Number

217343

Product Number

2

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2023-05-26

Regulatory Status

RX

2023
27 Jul
RX Application: 217344

Drug Name

TOBRAMYCIN

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2023-07-27

217344 / 1

Active Ingredient

TOBRAMYCIN

Application Number

217344

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2023-07-27

Regulatory Status

RX

2023
13 Mar
RX Application: 209738

Drug Name

TOFACITINIB CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2023-03-13

209738 / 1

Active Ingredient

TOFACITINIB CITRATE

Application Number

209738

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2023-03-13

Regulatory Status

RX

2026
03 Jun
RX Application: 209738

Drug Name

TOFACITINIB CITRATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2026-06-03

209738 / 2

Active Ingredient

TOFACITINIB CITRATE

Application Number

209738

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2026-06-03

Regulatory Status

RX

2026
01 May
RX Application: 217239

Drug Name

TORSEMIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2026-05-01

217239 / 1

Active Ingredient

TORSEMIDE

Application Number

217239

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2026-05-01

Regulatory Status

RX

2026
01 May
RX Application: 217239

Drug Name

TORSEMIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-05-01

217239 / 2

Active Ingredient

TORSEMIDE

Application Number

217239

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-05-01

Regulatory Status

RX

2026
01 May
RX Application: 217239

Drug Name

TORSEMIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2026-05-01

217239 / 3

Active Ingredient

TORSEMIDE

Application Number

217239

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2026-05-01

Regulatory Status

RX

2012
14 Dec
Discontinued Application: 201952

Drug Name

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;37.5MG

Approval Date

2012-12-14

201952 / 1

Active Ingredient

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Application Number

201952

Product Number

1

Dosage Form

-

Strength

325MG;37.5MG

Approval Date

2012-12-14

Regulatory Status

Discontinued

2017
27 Jun
RX Application: 206713

Drug Name

TRANEXAMIC ACID

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2017-06-27

206713 / 1

Active Ingredient

TRANEXAMIC ACID

Application Number

206713

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2017-06-27

Regulatory Status

RX

2021
19 Mar
RX Application: 203767

Drug Name

TRAVOPROST

Product Number

1

Dosage Form

-

Strength

0.004%

Approval Date

2021-03-19

203767 / 1

Active Ingredient

TRAVOPROST

Application Number

203767

Product Number

1

Dosage Form

-

Strength

0.004%

Approval Date

2021-03-19

Regulatory Status

RX

2006
09 Jun
RX Application: 40671

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

2006-06-09

40671 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

40671

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

2006-06-09

Regulatory Status

RX

2006
09 Jun
RX Application: 40671

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

2006-06-09

40671 / 2

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

40671

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

2006-06-09

Regulatory Status

RX

2006
13 Dec
RX Application: 40672

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

2006-12-13

40672 / 2

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

40672

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

2006-12-13

Regulatory Status

RX

2026
19 Mar
RX Application: 218838

Drug Name

VALGANCICLOVIR HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2026-03-19

218838 / 1

Active Ingredient

VALGANCICLOVIR HYDROCHLORIDE

Application Number

218838

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2026-03-19

Regulatory Status

RX

2025
29 Oct
RX Application: 218302

Drug Name

VARENICLINE TARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2025-10-29

218302 / 1

Active Ingredient

VARENICLINE TARTRATE

Application Number

218302

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2025-10-29

Regulatory Status

RX

2025
29 Oct
RX Application: 218302

Drug Name

VARENICLINE TARTRATE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2025-10-29

218302 / 2

Active Ingredient

VARENICLINE TARTRATE

Application Number

218302

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2025-10-29

Regulatory Status

RX

2018
28 Dec
RX Application: 211370

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/2ML (2.5MG/ML)

Approval Date

2018-12-28

211370 / 1

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

211370

Product Number

1

Dosage Form

-

Strength

5MG/2ML (2.5MG/ML)

Approval Date

2018-12-28

Regulatory Status

RX

2018
28 Dec
RX Application: 211370

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG/4ML (2.5MG/ML)

Approval Date

2018-12-28

211370 / 2

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

211370

Product Number

2

Dosage Form

-

Strength

10MG/4ML (2.5MG/ML)

Approval Date

2018-12-28

Regulatory Status

RX

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Drug Status Breakdown
214 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

207401

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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