MSN Laboratories
FDA Approved Drugs

MSN Laboratories

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 Unclassified Discontinued
  • Total Records 287
  • Latest Approval Date Jul 28, 2026
  • Data Source FDA
  • First Approval Date Sep 22, 2017
All
287
View
Unclassified
29
View
Discontinued
6
View
RX
252
View
Company Overview

Company

MSN Laboratories

Country

India

Website

Visit Website

Email

api@msnlabs.com

Social Profiles

Company Snapshot

MSN Laboratories

MSN House Plot No: C-24 Industrial Estate, Sanathnagar Hyderabad - 18 Telangana

India

www.msnlabs.com/ api@msnlabs.com View on Map
FDA Approved Drug Records ( 287 records )
2019
10 Jul
RX Application: 210686

Drug Name

ABIRATERONE ACETATE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2019-07-10

210686 / 1

Active Ingredient

ABIRATERONE ACETATE

Application Number

210686

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2019-07-10

Regulatory Status

RX

2024
24 Apr
RX Application: 210686

Drug Name

ABIRATERONE ACETATE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2024-04-24

210686 / 2

Active Ingredient

ABIRATERONE ACETATE

Application Number

210686

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2024-04-24

Regulatory Status

RX

-
Unclassified Application: 216833

Drug Name

ACALABRUTINIB

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

-

216833 / 1

Active Ingredient

ACALABRUTINIB

Application Number

216833

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

2023
09 Mar
RX Application: 217393

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

200MG/5ML

Approval Date

2023-03-09

217393 / 1

Active Ingredient

ACYCLOVIR

Application Number

217393

Product Number

1

Dosage Form

-

Strength

200MG/5ML

Approval Date

2023-03-09

Regulatory Status

RX

2021
21 Jan
RX Application: 213435

Drug Name

ALBENDAZOLE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2021-01-21

213435 / 1

Active Ingredient

ALBENDAZOLE

Application Number

213435

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2021-01-21

Regulatory Status

RX

-
Unclassified Application: 210212

Drug Name

ALOGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

12.5MG/500MG

Approval Date

-

210212 / 1

Active Ingredient

ALOGLIPTIN AND METFORMIN HYDROCHLORIDE

Application Number

210212

Product Number

1

Dosage Form

-

Strength

12.5MG/500MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 210212

Drug Name

ALOGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

12.5MG/1000MG

Approval Date

-

210212 / 2

Active Ingredient

ALOGLIPTIN AND METFORMIN HYDROCHLORIDE

Application Number

210212

Product Number

2

Dosage Form

-

Strength

12.5MG/1000MG

Approval Date

-

Regulatory Status

Unclassified

2020
06 Nov
RX Application: 212938

Drug Name

AMINOCAPROIC ACID

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2020-11-06

212938 / 1

Active Ingredient

AMINOCAPROIC ACID

Application Number

212938

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2020-11-06

Regulatory Status

RX

2023
13 Sep
RX Application: 212938

Drug Name

AMINOCAPROIC ACID

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2023-09-13

212938 / 2

Active Ingredient

AMINOCAPROIC ACID

Application Number

212938

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2023-09-13

Regulatory Status

RX

2024
26 Sep
RX Application: 215100

Drug Name

AMINOCAPROIC ACID

Product Number

1

Dosage Form

-

Strength

0.25GM/ML

Approval Date

2024-09-26

215100 / 1

Active Ingredient

AMINOCAPROIC ACID

Application Number

215100

Product Number

1

Dosage Form

-

Strength

0.25GM/ML

Approval Date

2024-09-26

Regulatory Status

RX

2024
16 Dec
RX Application: 211887

Drug Name

APREMILAST

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2024-12-16

211887 / 1

Active Ingredient

APREMILAST

Application Number

211887

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2024-12-16

Regulatory Status

RX

2024
16 Dec
RX Application: 211887

Drug Name

APREMILAST

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2024-12-16

211887 / 2

Active Ingredient

APREMILAST

Application Number

211887

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2024-12-16

Regulatory Status

RX

2024
16 Dec
RX Application: 211887

Drug Name

APREMILAST

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2024-12-16

211887 / 3

Active Ingredient

APREMILAST

Application Number

211887

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2024-12-16

Regulatory Status

RX

2023
20 Apr
RX Application: 217413

Drug Name

ARSENIC TRIOXIDE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2023-04-20

217413 / 1

Active Ingredient

ARSENIC TRIOXIDE

Application Number

217413

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2023-04-20

Regulatory Status

RX

2023
20 Apr
RX Application: 217413

Drug Name

ARSENIC TRIOXIDE

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

2023-04-20

217413 / 2

Active Ingredient

ARSENIC TRIOXIDE

Application Number

217413

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

2023-04-20

Regulatory Status

RX

2019
08 Feb
RX Application: 211933

Drug Name

ATORVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2019-02-08

211933 / 1

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

211933

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2019-02-08

Regulatory Status

RX

2019
08 Feb
RX Application: 211933

Drug Name

ATORVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2019-02-08

211933 / 2

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

211933

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2019-02-08

Regulatory Status

RX

2019
08 Feb
RX Application: 211933

Drug Name

ATORVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2019-02-08

211933 / 3

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

211933

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2019-02-08

Regulatory Status

RX

2019
08 Feb
RX Application: 211933

Drug Name

ATORVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2019-02-08

211933 / 4

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

211933

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2019-02-08

Regulatory Status

RX

2024
16 May
RX Application: 212580

Drug Name

AZACITIDINE

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2024-05-16

212580 / 1

Active Ingredient

AZACITIDINE

Application Number

212580

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2024-05-16

Regulatory Status

RX

2022
26 Jul
RX Application: 209622

Drug Name

BORTEZOMIB

Product Number

1

Dosage Form

-

Strength

3.5MG/VIAL

Approval Date

2022-07-26

209622 / 1

Active Ingredient

BORTEZOMIB

Application Number

209622

Product Number

1

Dosage Form

-

Strength

3.5MG/VIAL

Approval Date

2022-07-26

Regulatory Status

RX

2026
12 Jun
RX Application: 209624

Drug Name

BOSUTINIB MONOHYDRATE

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2026-06-12

209624 / 1

Active Ingredient

BOSUTINIB MONOHYDRATE

Application Number

209624

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2026-06-12

Regulatory Status

RX

2025
13 Nov
RX Application: 214921

Drug Name

BRIVARACETAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2025-11-13

214921 / 1

Active Ingredient

BRIVARACETAM

Application Number

214921

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2025-11-13

Regulatory Status

RX

2025
13 Nov
RX Application: 214921

Drug Name

BRIVARACETAM

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2025-11-13

214921 / 2

Active Ingredient

BRIVARACETAM

Application Number

214921

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2025-11-13

Regulatory Status

RX

2025
13 Nov
RX Application: 214921

Drug Name

BRIVARACETAM

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2025-11-13

214921 / 3

Active Ingredient

BRIVARACETAM

Application Number

214921

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2025-11-13

Regulatory Status

RX

2025
13 Nov
RX Application: 214921

Drug Name

BRIVARACETAM

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

2025-11-13

214921 / 4

Active Ingredient

BRIVARACETAM

Application Number

214921

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

2025-11-13

Regulatory Status

RX

2025
13 Nov
RX Application: 214921

Drug Name

BRIVARACETAM

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

2025-11-13

214921 / 5

Active Ingredient

BRIVARACETAM

Application Number

214921

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

2025-11-13

Regulatory Status

RX

2026
19 Feb
RX Application: 214922

Drug Name

BRIVARACETAM

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2026-02-19

214922 / 1

Active Ingredient

BRIVARACETAM

Application Number

214922

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2026-02-19

Regulatory Status

RX

2026
23 Feb
RX Application: 214924

Drug Name

BRIVARACETAM

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2026-02-23

214924 / 1

Active Ingredient

BRIVARACETAM

Application Number

214924

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2026-02-23

Regulatory Status

RX

2026
05 Feb
RX Application: 215362

Drug Name

BUMETANIDE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2026-02-05

215362 / 1

Active Ingredient

BUMETANIDE

Application Number

215362

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2026-02-05

Regulatory Status

RX

2026
05 Feb
RX Application: 215362

Drug Name

BUMETANIDE

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2026-02-05

215362 / 2

Active Ingredient

BUMETANIDE

Application Number

215362

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2026-02-05

Regulatory Status

RX

2026
05 Feb
RX Application: 215362

Drug Name

BUMETANIDE

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2026-02-05

215362 / 3

Active Ingredient

BUMETANIDE

Application Number

215362

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2026-02-05

Regulatory Status

RX

2022
04 Aug
RX Application: 215364

Drug Name

BUMETANIDE

Product Number

1

Dosage Form

-

Strength

0.25MG/ML

Approval Date

2022-08-04

215364 / 1

Active Ingredient

BUMETANIDE

Application Number

215364

Product Number

1

Dosage Form

-

Strength

0.25MG/ML

Approval Date

2022-08-04

Regulatory Status

RX

2026
04 Jun
RX Application: 213703

Drug Name

CANGRELOR

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2026-06-04

213703 / 1

Active Ingredient

CANGRELOR

Application Number

213703

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2026-06-04

Regulatory Status

RX

2018
02 Jul
RX Application: 209365

Drug Name

CAPECITABINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2018-07-02

209365 / 1

Active Ingredient

CAPECITABINE

Application Number

209365

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2018-07-02

Regulatory Status

RX

2018
02 Jul
RX Application: 209365

Drug Name

CAPECITABINE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2018-07-02

209365 / 2

Active Ingredient

CAPECITABINE

Application Number

209365

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2018-07-02

Regulatory Status

RX

2026
20 Jul
RX Application: 209526

Drug Name

CARFILZOMIB

Product Number

1

Dosage Form

-

Strength

60MG/VIAL

Approval Date

2026-07-20

209526 / 1

Active Ingredient

CARFILZOMIB

Application Number

209526

Product Number

1

Dosage Form

-

Strength

60MG/VIAL

Approval Date

2026-07-20

Regulatory Status

RX

2023
11 May
RX Application: 214814

Drug Name

CARMUSTINE

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2023-05-11

214814 / 1

Active Ingredient

CARMUSTINE

Application Number

214814

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2023-05-11

Regulatory Status

RX

2022
27 Jan
RX Application: 214827

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2022-01-27

214827 / 1

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

214827

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2022-01-27

Regulatory Status

RX

2022
27 Jan
RX Application: 214827

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2022-01-27

214827 / 2

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

214827

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2022-01-27

Regulatory Status

RX

2022
27 Jan
RX Application: 214827

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2022-01-27

214827 / 3

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

214827

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2022-01-27

Regulatory Status

RX

2022
27 Jan
RX Application: 214827

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2022-01-27

214827 / 4

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

214827

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2022-01-27

Regulatory Status

RX

2026
26 Jan
RX Application: 216092

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2026-01-26

216092 / 1

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

216092

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2026-01-26

Regulatory Status

RX

2021
11 May
RX Application: 213404

Drug Name

CLOBAZAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-05-11

213404 / 1

Active Ingredient

CLOBAZAM

Application Number

213404

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-05-11

Regulatory Status

RX

2021
11 May
RX Application: 213404

Drug Name

CLOBAZAM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2021-05-11

213404 / 2

Active Ingredient

CLOBAZAM

Application Number

213404

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2021-05-11

Regulatory Status

RX

2017
06 Dec
RX Application: 209775

Drug Name

CLOFARABINE

Product Number

1

Dosage Form

-

Strength

20MG/20ML (1MG/ML)

Approval Date

2017-12-06

209775 / 1

Active Ingredient

CLOFARABINE

Application Number

209775

Product Number

1

Dosage Form

-

Strength

20MG/20ML (1MG/ML)

Approval Date

2017-12-06

Regulatory Status

RX

2024
20 Sep
RX Application: 215388

Drug Name

CLOPIDOGREL BISULFATE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2024-09-20

215388 / 1

Active Ingredient

CLOPIDOGREL BISULFATE

Application Number

215388

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2024-09-20

Regulatory Status

RX

2024
22 May
RX Application: 213879

Drug Name

DABIGATRAN ETEXILATE MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2024-05-22

213879 / 1

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

213879

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2024-05-22

Regulatory Status

RX

2024
22 May
RX Application: 213879

Drug Name

DABIGATRAN ETEXILATE MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2024-05-22

213879 / 2

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

213879

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2024-05-22

Regulatory Status

RX

2024
12 Aug
RX Application: 213879

Drug Name

DABIGATRAN ETEXILATE MESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 110MG BASE

Approval Date

2024-08-12

213879 / 3

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

213879

Product Number

3

Dosage Form

-

Strength

EQ 110MG BASE

Approval Date

2024-08-12

Regulatory Status

RX

2026
06 Apr
RX Application: 211478

Drug Name

DAPAGLIFLOZIN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2026-04-06

211478 / 1

Active Ingredient

DAPAGLIFLOZIN

Application Number

211478

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211478

Drug Name

DAPAGLIFLOZIN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-04-06

211478 / 2

Active Ingredient

DAPAGLIFLOZIN

Application Number

211478

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211479

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG;500MG

Approval Date

2026-04-06

211479 / 1

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211479

Product Number

1

Dosage Form

-

Strength

5MG;500MG

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211479

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG;1GM

Approval Date

2026-04-06

211479 / 2

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211479

Product Number

2

Dosage Form

-

Strength

5MG;1GM

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211479

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG;500MG

Approval Date

2026-04-06

211479 / 3

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211479

Product Number

3

Dosage Form

-

Strength

10MG;500MG

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211479

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

10MG;1GM

Approval Date

2026-04-06

211479 / 4

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211479

Product Number

4

Dosage Form

-

Strength

10MG;1GM

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211533

Drug Name

DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG;EQ 5MG BASE

Approval Date

2026-04-06

211533 / 1

Active Ingredient

DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE

Application Number

211533

Product Number

1

Dosage Form

-

Strength

10MG;EQ 5MG BASE

Approval Date

2026-04-06

Regulatory Status

RX

2023
28 Nov
RX Application: 215389

Drug Name

DARUNAVIR

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2023-11-28

215389 / 1

Active Ingredient

DARUNAVIR

Application Number

215389

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2023-11-28

Regulatory Status

RX

2023
28 Nov
RX Application: 215389

Drug Name

DARUNAVIR

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2023-11-28

215389 / 2

Active Ingredient

DARUNAVIR

Application Number

215389

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2023-11-28

Regulatory Status

RX

2019
28 Aug
RX Application: 212265

Drug Name

DECITABINE

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2019-08-28

212265 / 1

Active Ingredient

DECITABINE

Application Number

212265

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2019-08-28

Regulatory Status

RX

2019
20 Nov
RX Application: 209878

Drug Name

DEFERASIROX

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2019-11-20

209878 / 1

Active Ingredient

DEFERASIROX

Application Number

209878

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2019-11-20

Regulatory Status

RX

2019
20 Nov
RX Application: 209878

Drug Name

DEFERASIROX

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2019-11-20

209878 / 2

Active Ingredient

DEFERASIROX

Application Number

209878

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2019-11-20

Regulatory Status

RX

2019
20 Nov
RX Application: 209878

Drug Name

DEFERASIROX

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2019-11-20

209878 / 3

Active Ingredient

DEFERASIROX

Application Number

209878

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2019-11-20

Regulatory Status

RX

2019
20 Nov
RX Application: 210945

Drug Name

DEFERASIROX

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2019-11-20

210945 / 1

Active Ingredient

DEFERASIROX

Application Number

210945

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2019-11-20

Regulatory Status

RX

2019
20 Nov
RX Application: 210945

Drug Name

DEFERASIROX

Product Number

2

Dosage Form

-

Strength

360MG

Approval Date

2019-11-20

210945 / 2

Active Ingredient

DEFERASIROX

Application Number

210945

Product Number

2

Dosage Form

-

Strength

360MG

Approval Date

2019-11-20

Regulatory Status

RX

2020
16 Jun
RX Application: 210945

Drug Name

DEFERASIROX

Product Number

3

Dosage Form

-

Strength

180MG

Approval Date

2020-06-16

210945 / 3

Active Ingredient

DEFERASIROX

Application Number

210945

Product Number

3

Dosage Form

-

Strength

180MG

Approval Date

2020-06-16

Regulatory Status

RX

2021
17 Mar
RX Application: 214650

Drug Name

DEFERASIROX

Product Number

1

Dosage Form

-

Strength

180MG

Approval Date

2021-03-17

214650 / 1

Active Ingredient

DEFERASIROX

Application Number

214650

Product Number

1

Dosage Form

-

Strength

180MG

Approval Date

2021-03-17

Regulatory Status

RX

2021
17 Mar
RX Application: 214650

Drug Name

DEFERASIROX

Product Number

2

Dosage Form

-

Strength

360MG

Approval Date

2021-03-17

214650 / 2

Active Ingredient

DEFERASIROX

Application Number

214650

Product Number

2

Dosage Form

-

Strength

360MG

Approval Date

2021-03-17

Regulatory Status

RX

2022
20 Apr
RX Application: 214650

Drug Name

DEFERASIROX

Product Number

3

Dosage Form

-

Strength

90MG

Approval Date

2022-04-20

214650 / 3

Active Ingredient

DEFERASIROX

Application Number

214650

Product Number

3

Dosage Form

-

Strength

90MG

Approval Date

2022-04-20

Regulatory Status

RX

2025
26 Mar
RX Application: 216748

Drug Name

DEXRAZOXANE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2025-03-26

216748 / 1

Active Ingredient

DEXRAZOXANE HYDROCHLORIDE

Application Number

216748

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2025-03-26

Regulatory Status

RX

2025
26 Mar
RX Application: 216748

Drug Name

DEXRAZOXANE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2025-03-26

216748 / 2

Active Ingredient

DEXRAZOXANE HYDROCHLORIDE

Application Number

216748

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2025-03-26

Regulatory Status

RX

2020
24 Sep
RX Application: 210460

Drug Name

DIMETHYL FUMARATE

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2020-09-24

210460 / 1

Active Ingredient

DIMETHYL FUMARATE

Application Number

210460

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2020-09-24

Regulatory Status

RX

2020
24 Sep
RX Application: 210460

Drug Name

DIMETHYL FUMARATE

Product Number

2

Dosage Form

-

Strength

240MG

Approval Date

2020-09-24

210460 / 2

Active Ingredient

DIMETHYL FUMARATE

Application Number

210460

Product Number

2

Dosage Form

-

Strength

240MG

Approval Date

2020-09-24

Regulatory Status

RX

2020
29 Jan
RX Application: 213220

Drug Name

DOFETILIDE

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2020-01-29

213220 / 1

Active Ingredient

DOFETILIDE

Application Number

213220

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2020-01-29

Regulatory Status

RX

2020
29 Jan
RX Application: 213220

Drug Name

DOFETILIDE

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2020-01-29

213220 / 2

Active Ingredient

DOFETILIDE

Application Number

213220

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2020-01-29

Regulatory Status

RX

2020
29 Jan
RX Application: 213220

Drug Name

DOFETILIDE

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2020-01-29

213220 / 3

Active Ingredient

DOFETILIDE

Application Number

213220

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2020-01-29

Regulatory Status

RX

2023
03 Apr
RX Application: 214823

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2023-04-03

214823 / 1

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

214823

Product Number

1

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2023-04-03

Regulatory Status

RX

2023
03 Apr
RX Application: 214823

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2023-04-03

214823 / 2

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

214823

Product Number

2

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2023-04-03

Regulatory Status

RX

2022
24 Jun
RX Application: 215113

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2022-06-24

215113 / 1

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

215113

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2022-06-24

Regulatory Status

RX

2022
24 Jun
RX Application: 215113

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2022-06-24

215113 / 2

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

215113

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2022-06-24

Regulatory Status

RX

2022
24 Jun
RX Application: 215113

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2022-06-24

215113 / 3

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

215113

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2022-06-24

Regulatory Status

RX

2022
24 Jun
RX Application: 215113

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2022-06-24

215113 / 4

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

215113

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2022-06-24

Regulatory Status

RX

2022
24 Jun
RX Application: 215113

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2022-06-24

215113 / 5

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

215113

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2022-06-24

Regulatory Status

RX

2026
14 Jan
RX Application: 220250

Drug Name

ELTROMBOPAG OLAMINE

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG ACID

Approval Date

2026-01-14

220250 / 1

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

220250

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG ACID

Approval Date

2026-01-14

Regulatory Status

RX

2026
14 Jan
RX Application: 220250

Drug Name

ELTROMBOPAG OLAMINE

Product Number

2

Dosage Form

-

Strength

EQ 25MG ACID

Approval Date

2026-01-14

220250 / 2

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

220250

Product Number

2

Dosage Form

-

Strength

EQ 25MG ACID

Approval Date

2026-01-14

Regulatory Status

RX

2026
14 Jan
RX Application: 220250

Drug Name

ELTROMBOPAG OLAMINE

Product Number

3

Dosage Form

-

Strength

EQ 50MG ACID

Approval Date

2026-01-14

220250 / 3

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

220250

Product Number

3

Dosage Form

-

Strength

EQ 50MG ACID

Approval Date

2026-01-14

Regulatory Status

RX

2026
14 Jan
RX Application: 220250

Drug Name

ELTROMBOPAG OLAMINE

Product Number

4

Dosage Form

-

Strength

EQ 75MG ACID

Approval Date

2026-01-14

220250 / 4

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

220250

Product Number

4

Dosage Form

-

Strength

EQ 75MG ACID

Approval Date

2026-01-14

Regulatory Status

RX

2021
10 May
RX Application: 214366

Drug Name

ERLOTINIB HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2021-05-10

214366 / 1

Active Ingredient

ERLOTINIB HYDROCHLORIDE

Application Number

214366

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2021-05-10

Regulatory Status

RX

2021
10 May
RX Application: 214366

Drug Name

ERLOTINIB HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2021-05-10

214366 / 2

Active Ingredient

ERLOTINIB HYDROCHLORIDE

Application Number

214366

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2021-05-10

Regulatory Status

RX

2021
10 May
RX Application: 214366

Drug Name

ERLOTINIB HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2021-05-10

214366 / 3

Active Ingredient

ERLOTINIB HYDROCHLORIDE

Application Number

214366

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2021-05-10

Regulatory Status

RX

2024
06 Aug
RX Application: 217400

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2024-08-06

217400 / 1

Active Ingredient

FAMOTIDINE

Application Number

217400

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2024-08-06

Regulatory Status

RX

2024
06 Aug
RX Application: 217400

Drug Name

FAMOTIDINE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2024-08-06

217400 / 2

Active Ingredient

FAMOTIDINE

Application Number

217400

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2024-08-06

Regulatory Status

RX

2025
24 Jul
RX Application: 219863

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

2025-07-24

219863 / 1

Active Ingredient

FAMOTIDINE

Application Number

219863

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

2025-07-24

Regulatory Status

RX

2019
30 Dec
RX Application: 210461

Drug Name

FEBUXOSTAT

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2019-12-30

210461 / 1

Active Ingredient

FEBUXOSTAT

Application Number

210461

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2019-12-30

Regulatory Status

RX

2019
30 Dec
RX Application: 210461

Drug Name

FEBUXOSTAT

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2019-12-30

210461 / 2

Active Ingredient

FEBUXOSTAT

Application Number

210461

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2019-12-30

Regulatory Status

RX

2023
02 Nov
RX Application: 215365

Drug Name

FLUPHENAZINE DECANOATE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2023-11-02

215365 / 1

Active Ingredient

FLUPHENAZINE DECANOATE

Application Number

215365

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2023-11-02

Regulatory Status

RX

2023
11 Sep
RX Application: 217189

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2023-09-11

217189 / 1

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

217189

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2023-09-11

Regulatory Status

RX

2023
11 Sep
RX Application: 217189

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2023-09-11

217189 / 2

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

217189

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2023-09-11

Regulatory Status

RX

2023
11 Sep
RX Application: 217189

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2023-09-11

217189 / 3

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

217189

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2023-09-11

Regulatory Status

RX

2023
11 Sep
RX Application: 217189

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2023-09-11

217189 / 4

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

217189

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2023-09-11

Regulatory Status

RX

2019
05 Sep
RX Application: 209965

Drug Name

FOSAPREPITANT DIMEGLUMINE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/VIAL

Approval Date

2019-09-05

209965 / 1

Active Ingredient

FOSAPREPITANT DIMEGLUMINE

Application Number

209965

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/VIAL

Approval Date

2019-09-05

Regulatory Status

RX

2026
15 Apr
RX Application: 219540

Drug Name

GLYCEROL PHENYLBUTYRATE

Product Number

1

Dosage Form

-

Strength

1.1GM/ML

Approval Date

2026-04-15

219540 / 1

Active Ingredient

GLYCEROL PHENYLBUTYRATE

Application Number

219540

Product Number

1

Dosage Form

-

Strength

1.1GM/ML

Approval Date

2026-04-15

Regulatory Status

RX

2025
08 Apr
RX Application: 216084

Drug Name

GLYCOPYRROLATE

Product Number

1

Dosage Form

-

Strength

1MG/5ML

Approval Date

2025-04-08

216084 / 1

Active Ingredient

GLYCOPYRROLATE

Application Number

216084

Product Number

1

Dosage Form

-

Strength

1MG/5ML

Approval Date

2025-04-08

Regulatory Status

RX

2022
18 Nov
RX Application: 216004

Drug Name

HALOPERIDOL

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2022-11-18

216004 / 1

Active Ingredient

HALOPERIDOL

Application Number

216004

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2022-11-18

Regulatory Status

RX

2022
18 Nov
RX Application: 216004

Drug Name

HALOPERIDOL

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2022-11-18

216004 / 2

Active Ingredient

HALOPERIDOL

Application Number

216004

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2022-11-18

Regulatory Status

RX

2022
18 Nov
RX Application: 216004

Drug Name

HALOPERIDOL

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2022-11-18

216004 / 3

Active Ingredient

HALOPERIDOL

Application Number

216004

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2022-11-18

Regulatory Status

RX

2022
18 Nov
RX Application: 216004

Drug Name

HALOPERIDOL

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

2022-11-18

216004 / 4

Active Ingredient

HALOPERIDOL

Application Number

216004

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

2022-11-18

Regulatory Status

RX

2022
18 Nov
RX Application: 216004

Drug Name

HALOPERIDOL

Product Number

5

Dosage Form

-

Strength

10MG

Approval Date

2022-11-18

216004 / 5

Active Ingredient

HALOPERIDOL

Application Number

216004

Product Number

5

Dosage Form

-

Strength

10MG

Approval Date

2022-11-18

Regulatory Status

RX

2022
18 Nov
RX Application: 216004

Drug Name

HALOPERIDOL

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2022-11-18

216004 / 6

Active Ingredient

HALOPERIDOL

Application Number

216004

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2022-11-18

Regulatory Status

RX

2025
04 Nov
RX Application: 219539

Drug Name

IRBESARTAN

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2025-11-04

219539 / 1

Active Ingredient

IRBESARTAN

Application Number

219539

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2025-11-04

Regulatory Status

RX

2025
04 Nov
RX Application: 219539

Drug Name

IRBESARTAN

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2025-11-04

219539 / 2

Active Ingredient

IRBESARTAN

Application Number

219539

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2025-11-04

Regulatory Status

RX

2025
04 Nov
RX Application: 219539

Drug Name

IRBESARTAN

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2025-11-04

219539 / 3

Active Ingredient

IRBESARTAN

Application Number

219539

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2025-11-04

Regulatory Status

RX

2022
16 Sep
RX Application: 216090

Drug Name

ISOSULFAN BLUE

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2022-09-16

216090 / 1

Active Ingredient

ISOSULFAN BLUE

Application Number

216090

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2022-09-16

Regulatory Status

RX

2025
28 Apr
RX Application: 213483

Drug Name

IVABRADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2025-04-28

213483 / 1

Active Ingredient

IVABRADINE HYDROCHLORIDE

Application Number

213483

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2025-04-28

Regulatory Status

RX

2025
28 Apr
RX Application: 213483

Drug Name

IVABRADINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 7.5MG BASE

Approval Date

2025-04-28

213483 / 2

Active Ingredient

IVABRADINE HYDROCHLORIDE

Application Number

213483

Product Number

2

Dosage Form

-

Strength

EQ 7.5MG BASE

Approval Date

2025-04-28

Regulatory Status

RX

2022
17 Mar
RX Application: 204921

Drug Name

LACOSAMIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2022-03-17

204921 / 1

Active Ingredient

LACOSAMIDE

Application Number

204921

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2022-03-17

Regulatory Status

RX

2022
17 Mar
RX Application: 204921

Drug Name

LACOSAMIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2022-03-17

204921 / 2

Active Ingredient

LACOSAMIDE

Application Number

204921

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2022-03-17

Regulatory Status

RX

2022
17 Mar
RX Application: 204921

Drug Name

LACOSAMIDE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2022-03-17

204921 / 3

Active Ingredient

LACOSAMIDE

Application Number

204921

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2022-03-17

Regulatory Status

RX

2022
17 Mar
RX Application: 204921

Drug Name

LACOSAMIDE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2022-03-17

204921 / 4

Active Ingredient

LACOSAMIDE

Application Number

204921

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2022-03-17

Regulatory Status

RX

2023
22 Dec
RX Application: 215379

Drug Name

LACOSAMIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2023-12-22

215379 / 1

Active Ingredient

LACOSAMIDE

Application Number

215379

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2023-12-22

Regulatory Status

RX

2023
09 Feb
RX Application: 215979

Drug Name

LACOSAMIDE

Product Number

1

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2023-02-09

215979 / 1

Active Ingredient

LACOSAMIDE

Application Number

215979

Product Number

1

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2023-02-09

Regulatory Status

RX

2022
15 Jul
RX Application: 214757

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2022-07-15

214757 / 1

Active Ingredient

LEVETIRACETAM

Application Number

214757

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2022-07-15

Regulatory Status

RX

2022
07 Oct
RX Application: 214815

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2022-10-07

214815 / 1

Active Ingredient

LEVETIRACETAM

Application Number

214815

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2022-10-07

Regulatory Status

RX

2022
07 Oct
RX Application: 214815

Drug Name

LEVETIRACETAM

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2022-10-07

214815 / 2

Active Ingredient

LEVETIRACETAM

Application Number

214815

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2022-10-07

Regulatory Status

RX

2022
07 Oct
RX Application: 214815

Drug Name

LEVETIRACETAM

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2022-10-07

214815 / 3

Active Ingredient

LEVETIRACETAM

Application Number

214815

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2022-10-07

Regulatory Status

RX

2022
07 Oct
RX Application: 214815

Drug Name

LEVETIRACETAM

Product Number

4

Dosage Form

-

Strength

1GM

Approval Date

2022-10-07

214815 / 4

Active Ingredient

LEVETIRACETAM

Application Number

214815

Product Number

4

Dosage Form

-

Strength

1GM

Approval Date

2022-10-07

Regulatory Status

RX

2022
15 Nov
RX Application: 215980

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2022-11-15

215980 / 1

Active Ingredient

LEVETIRACETAM

Application Number

215980

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2022-11-15

Regulatory Status

RX

-
Unclassified Application: 210805

Drug Name

LEVOMILNACIPRAN

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

-

210805 / 1

Active Ingredient

LEVOMILNACIPRAN

Application Number

210805

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 210805

Drug Name

LEVOMILNACIPRAN

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

-

210805 / 2

Active Ingredient

LEVOMILNACIPRAN

Application Number

210805

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 210805

Drug Name

LEVOMILNACIPRAN

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

-

210805 / 3

Active Ingredient

LEVOMILNACIPRAN

Application Number

210805

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 210805

Drug Name

LEVOMILNACIPRAN

Product Number

4

Dosage Form

-

Strength

120MG

Approval Date

-

210805 / 4

Active Ingredient

LEVOMILNACIPRAN

Application Number

210805

Product Number

4

Dosage Form

-

Strength

120MG

Approval Date

-

Regulatory Status

Unclassified

2025
03 Nov
RX Application: 208457

Drug Name

LINAGLIPTIN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2025-11-03

208457 / 1

Active Ingredient

LINAGLIPTIN

Application Number

208457

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2025-11-03

Regulatory Status

RX

2025
03 Nov
RX Application: 208459

Drug Name

LINAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG;500MG

Approval Date

2025-11-03

208459 / 1

Active Ingredient

LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Application Number

208459

Product Number

1

Dosage Form

-

Strength

2.5MG;500MG

Approval Date

2025-11-03

Regulatory Status

RX

2025
03 Nov
RX Application: 208459

Drug Name

LINAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2.5MG;850MG

Approval Date

2025-11-03

208459 / 2

Active Ingredient

LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Application Number

208459

Product Number

2

Dosage Form

-

Strength

2.5MG;850MG

Approval Date

2025-11-03

Regulatory Status

RX

2025
03 Nov
RX Application: 208459

Drug Name

LINAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

2.5MG;1GM

Approval Date

2025-11-03

208459 / 3

Active Ingredient

LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Application Number

208459

Product Number

3

Dosage Form

-

Strength

2.5MG;1GM

Approval Date

2025-11-03

Regulatory Status

RX

2024
02 Feb
RX Application: 218306

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2024-02-02

218306 / 1

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

218306

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2024-02-02

Regulatory Status

RX

2024
02 Feb
RX Application: 218306

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2024-02-02

218306 / 2

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

218306

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2024-02-02

Regulatory Status

RX

2024
02 Feb
RX Application: 218306

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2024-02-02

218306 / 3

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

218306

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2024-02-02

Regulatory Status

RX

2024
02 Feb
RX Application: 218306

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2024-02-02

218306 / 4

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

218306

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2024-02-02

Regulatory Status

RX

2024
02 Feb
RX Application: 218306

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2024-02-02

218306 / 5

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

218306

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2024-02-02

Regulatory Status

RX

2024
02 Feb
RX Application: 218306

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2024-02-02

218306 / 6

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

218306

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2024-02-02

Regulatory Status

RX

2025
24 Feb
RX Application: 218699

Drug Name

LOFEXIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.18MG BASE

Approval Date

2025-02-24

218699 / 1

Active Ingredient

LOFEXIDINE HYDROCHLORIDE

Application Number

218699

Product Number

1

Dosage Form

-

Strength

EQ 0.18MG BASE

Approval Date

2025-02-24

Regulatory Status

RX

2023
14 Aug
RX Application: 217396

Drug Name

LOSARTAN POTASSIUM

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2023-08-14

217396 / 1

Active Ingredient

LOSARTAN POTASSIUM

Application Number

217396

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2023-08-14

Regulatory Status

RX

2023
14 Aug
RX Application: 217396

Drug Name

LOSARTAN POTASSIUM

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2023-08-14

217396 / 2

Active Ingredient

LOSARTAN POTASSIUM

Application Number

217396

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2023-08-14

Regulatory Status

RX

2023
14 Aug
RX Application: 217396

Drug Name

LOSARTAN POTASSIUM

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2023-08-14

217396 / 3

Active Ingredient

LOSARTAN POTASSIUM

Application Number

217396

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2023-08-14

Regulatory Status

RX

-
Unclassified Application: 219248

Drug Name

LUMATEPERONE TOSYLATE

Product Number

1

Dosage Form

-

Strength

10.5MG

Approval Date

-

219248 / 1

Active Ingredient

LUMATEPERONE TOSYLATE

Application Number

219248

Product Number

1

Dosage Form

-

Strength

10.5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 219248

Drug Name

LUMATEPERONE TOSYLATE

Product Number

2

Dosage Form

-

Strength

21MG

Approval Date

-

219248 / 2

Active Ingredient

LUMATEPERONE TOSYLATE

Application Number

219248

Product Number

2

Dosage Form

-

Strength

21MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 219248

Drug Name

LUMATEPERONE TOSYLATE

Product Number

3

Dosage Form

-

Strength

42MG

Approval Date

-

219248 / 3

Active Ingredient

LUMATEPERONE TOSYLATE

Application Number

219248

Product Number

3

Dosage Form

-

Strength

42MG

Approval Date

-

Regulatory Status

Unclassified

2022
09 Sep
RX Application: 208037

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2022-09-09

208037 / 1

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208037

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2022-09-09

Regulatory Status

RX

2022
09 Sep
RX Application: 208037

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2022-09-09

208037 / 2

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208037

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2022-09-09

Regulatory Status

RX

2022
09 Sep
RX Application: 208037

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2022-09-09

208037 / 3

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208037

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2022-09-09

Regulatory Status

RX

2022
09 Sep
RX Application: 208037

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2022-09-09

208037 / 4

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208037

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2022-09-09

Regulatory Status

RX

2022
09 Sep
RX Application: 208037

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

120MG

Approval Date

2022-09-09

208037 / 5

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208037

Product Number

5

Dosage Form

-

Strength

120MG

Approval Date

2022-09-09

Regulatory Status

RX

2025
20 Aug
RX Application: 211136

Drug Name

MACITENTAN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2025-08-20

211136 / 1

Active Ingredient

MACITENTAN

Application Number

211136

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2025-08-20

Regulatory Status

RX

2025
04 Nov
RX Application: 218543

Drug Name

MIRABEGRON

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2025-11-04

218543 / 1

Active Ingredient

MIRABEGRON

Application Number

218543

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2025-11-04

Regulatory Status

RX

2025
04 Nov
RX Application: 218543

Drug Name

MIRABEGRON

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2025-11-04

218543 / 2

Active Ingredient

MIRABEGRON

Application Number

218543

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2025-11-04

Regulatory Status

RX

2017
22 Sep
RX Application: 208682

Drug Name

MOXIFLOXACIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2017-09-22

208682 / 1

Active Ingredient

MOXIFLOXACIN HYDROCHLORIDE

Application Number

208682

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2017-09-22

Regulatory Status

RX

2024
01 Oct
RX Application: 217397

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2024-10-01

217397 / 1

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

217397

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2024-10-01

Regulatory Status

RX

2024
01 Oct
RX Application: 217397

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2024-10-01

217397 / 2

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

217397

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2024-10-01

Regulatory Status

RX

2024
01 Oct
RX Application: 217397

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2024-10-01

217397 / 3

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

217397

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2024-10-01

Regulatory Status

RX

2024
01 Oct
RX Application: 217397

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2024-10-01

217397 / 4

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

217397

Product Number

4

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2024-10-01

Regulatory Status

RX

2024
13 Sep
RX Application: 216948

Drug Name

NELARABINE

Product Number

1

Dosage Form

-

Strength

250MG/50ML (5MG/ML)

Approval Date

2024-09-13

216948 / 1

Active Ingredient

NELARABINE

Application Number

216948

Product Number

1

Dosage Form

-

Strength

250MG/50ML (5MG/ML)

Approval Date

2024-09-13

Regulatory Status

RX

2025
19 Nov
RX Application: 218544

Drug Name

NILOTINIB HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2025-11-19

218544 / 1

Active Ingredient

NILOTINIB HYDROCHLORIDE

Application Number

218544

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2025-11-19

Regulatory Status

RX

2025
19 Nov
RX Application: 218544

Drug Name

NILOTINIB HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2025-11-19

218544 / 2

Active Ingredient

NILOTINIB HYDROCHLORIDE

Application Number

218544

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2025-11-19

Regulatory Status

RX

2025
19 Nov
RX Application: 218544

Drug Name

NILOTINIB HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2025-11-19

218544 / 3

Active Ingredient

NILOTINIB HYDROCHLORIDE

Application Number

218544

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2025-11-19

Regulatory Status

RX

2025
11 Dec
RX Application: 218595

Drug Name

NOREPINEPHRINE BITARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2025-12-11

218595 / 1

Active Ingredient

NOREPINEPHRINE BITARTRATE

Application Number

218595

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2025-12-11

Regulatory Status

RX

2023
30 May
Discontinued Application: 215017

Drug Name

OBETICHOLIC ACID

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2023-05-30

215017 / 1

Active Ingredient

OBETICHOLIC ACID

Application Number

215017

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2023-05-30

Regulatory Status

Discontinued

2023
30 May
Discontinued Application: 215017

Drug Name

OBETICHOLIC ACID

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2023-05-30

215017 / 2

Active Ingredient

OBETICHOLIC ACID

Application Number

215017

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2023-05-30

Regulatory Status

Discontinued

2023
18 Jan
RX Application: 217399

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2023-01-18

217399 / 1

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

217399

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2023-01-18

Regulatory Status

RX

2023
18 Jan
RX Application: 217399

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2023-01-18

217399 / 2

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

217399

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2023-01-18

Regulatory Status

RX

2023
18 Jan
RX Application: 217399

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2023-01-18

217399 / 3

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

217399

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2023-01-18

Regulatory Status

RX

2025
26 Sep
RX Application: 217398

Drug Name

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2025-09-26

217398 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

217398

Product Number

1

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2025-09-26

Regulatory Status

RX

2025
26 Sep
RX Application: 217398

Drug Name

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;40MG

Approval Date

2025-09-26

217398 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

217398

Product Number

2

Dosage Form

-

Strength

12.5MG;40MG

Approval Date

2025-09-26

Regulatory Status

RX

2025
26 Sep
RX Application: 217398

Drug Name

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;40MG

Approval Date

2025-09-26

217398 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

217398

Product Number

3

Dosage Form

-

Strength

25MG;40MG

Approval Date

2025-09-26

Regulatory Status

RX

2025
08 Aug
RX Application: 217585

Drug Name

OLUMIANT

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2025-08-08

217585 / 1

Active Ingredient

BARICITINIB

Application Number

217585

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2025-08-08

Regulatory Status

RX

2025
08 Aug
RX Application: 217585

Drug Name

OLUMIANT

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2025-08-08

217585 / 2

Active Ingredient

BARICITINIB

Application Number

217585

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2025-08-08

Regulatory Status

RX

2025
08 Aug
RX Application: 217585

Drug Name

OLUMIANT

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2025-08-08

217585 / 3

Active Ingredient

BARICITINIB

Application Number

217585

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2025-08-08

Regulatory Status

RX

2020
20 May
RX Application: 212544

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2020-05-20

212544 / 1

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

212544

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2020-05-20

Regulatory Status

RX

2020
20 May
RX Application: 212544

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

2

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2020-05-20

212544 / 2

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

212544

Product Number

2

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2020-05-20

Regulatory Status

RX

2020
20 May
RX Application: 212544

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2020-05-20

212544 / 3

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

212544

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2020-05-20

Regulatory Status

RX

2022
02 May
RX Application: 215313

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

2022-05-02

215313 / 1

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

215313

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

2022-05-02

Regulatory Status

RX

2026
29 May
RX Application: 209020

Drug Name

OXCARBAZEPINE

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2026-05-29

209020 / 1

Active Ingredient

OXCARBAZEPINE

Application Number

209020

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2026-05-29

Regulatory Status

RX

2020
24 Aug
RX Application: 213434

Drug Name

PACLITAXEL

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2020-08-24

213434 / 1

Active Ingredient

PACLITAXEL

Application Number

213434

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2020-08-24

Regulatory Status

RX

2025
11 Jul
RX Application: 218152

Drug Name

PERAMPANEL

Product Number

1

Dosage Form

-

Strength

0.5MG/ML

Approval Date

2025-07-11

218152 / 1

Active Ingredient

PERAMPANEL

Application Number

218152

Product Number

1

Dosage Form

-

Strength

0.5MG/ML

Approval Date

2025-07-11

Regulatory Status

RX

2025
25 Nov
RX Application: 218178

Drug Name

PERAMPANEL

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2025-11-25

218178 / 1

Active Ingredient

PERAMPANEL

Application Number

218178

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2025-11-25

Regulatory Status

RX

2025
25 Nov
RX Application: 218178

Drug Name

PERAMPANEL

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2025-11-25

218178 / 2

Active Ingredient

PERAMPANEL

Application Number

218178

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2025-11-25

Regulatory Status

RX

2025
25 Nov
RX Application: 218178

Drug Name

PERAMPANEL

Product Number

3

Dosage Form

-

Strength

6MG

Approval Date

2025-11-25

218178 / 3

Active Ingredient

PERAMPANEL

Application Number

218178

Product Number

3

Dosage Form

-

Strength

6MG

Approval Date

2025-11-25

Regulatory Status

RX

2025
25 Nov
RX Application: 218178

Drug Name

PERAMPANEL

Product Number

4

Dosage Form

-

Strength

8MG

Approval Date

2025-11-25

218178 / 4

Active Ingredient

PERAMPANEL

Application Number

218178

Product Number

4

Dosage Form

-

Strength

8MG

Approval Date

2025-11-25

Regulatory Status

RX

2025
25 Nov
RX Application: 218178

Drug Name

PERAMPANEL

Product Number

5

Dosage Form

-

Strength

10MG

Approval Date

2025-11-25

218178 / 5

Active Ingredient

PERAMPANEL

Application Number

218178

Product Number

5

Dosage Form

-

Strength

10MG

Approval Date

2025-11-25

Regulatory Status

RX

2025
25 Nov
RX Application: 218178

Drug Name

PERAMPANEL

Product Number

6

Dosage Form

-

Strength

12MG

Approval Date

2025-11-25

218178 / 6

Active Ingredient

PERAMPANEL

Application Number

218178

Product Number

6

Dosage Form

-

Strength

12MG

Approval Date

2025-11-25

Regulatory Status

RX

2024
16 Jan
Discontinued Application: 214925

Drug Name

PIMAVANSERIN

Product Number

1

Dosage Form

-

Strength

EQ 34MG BASE

Approval Date

2024-01-16

214925 / 1

Active Ingredient

PIMAVANSERIN TARTRATE

Application Number

214925

Product Number

1

Dosage Form

-

Strength

EQ 34MG BASE

Approval Date

2024-01-16

Regulatory Status

Discontinued

2022
24 May
RX Application: 212772

Drug Name

PIRFENIDONE

Product Number

1

Dosage Form

-

Strength

267MG

Approval Date

2022-05-24

212772 / 1

Active Ingredient

PIRFENIDONE

Application Number

212772

Product Number

1

Dosage Form

-

Strength

267MG

Approval Date

2022-05-24

Regulatory Status

RX

2022
24 May
RX Application: 212772

Drug Name

PIRFENIDONE

Product Number

2

Dosage Form

-

Strength

801MG

Approval Date

2022-05-24

212772 / 2

Active Ingredient

PIRFENIDONE

Application Number

212772

Product Number

2

Dosage Form

-

Strength

801MG

Approval Date

2022-05-24

Regulatory Status

RX

2023
24 Jul
RX Application: 211901

Drug Name

PLERIXAFOR

Product Number

1

Dosage Form

-

Strength

24MG/1.2ML (20MG/ML)

Approval Date

2023-07-24

211901 / 1

Active Ingredient

PLERIXAFOR

Application Number

211901

Product Number

1

Dosage Form

-

Strength

24MG/1.2ML (20MG/ML)

Approval Date

2023-07-24

Regulatory Status

RX

2025
24 Feb
RX Application: 218434

Drug Name

POSACONAZOLE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2025-02-24

218434 / 1

Active Ingredient

POSACONAZOLE

Application Number

218434

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2025-02-24

Regulatory Status

RX

2024
17 Sep
RX Application: 216727

Drug Name

PRAZOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2024-09-17

216727 / 1

Active Ingredient

PRAZOSIN HYDROCHLORIDE

Application Number

216727

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2024-09-17

Regulatory Status

RX

2024
17 Sep
RX Application: 216727

Drug Name

PRAZOSIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2024-09-17

216727 / 2

Active Ingredient

PRAZOSIN HYDROCHLORIDE

Application Number

216727

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2024-09-17

Regulatory Status

RX

2024
17 Sep
RX Application: 216727

Drug Name

PRAZOSIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2024-09-17

216727 / 3

Active Ingredient

PRAZOSIN HYDROCHLORIDE

Application Number

216727

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2024-09-17

Regulatory Status

RX

2019
19 Jul
RX Application: 209357

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-07-19

209357 / 1

Active Ingredient

PREGABALIN

Application Number

209357

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 209357

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2019-07-19

209357 / 2

Active Ingredient

PREGABALIN

Application Number

209357

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 209357

Drug Name

PREGABALIN

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2019-07-19

209357 / 3

Active Ingredient

PREGABALIN

Application Number

209357

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 209357

Drug Name

PREGABALIN

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2019-07-19

209357 / 4

Active Ingredient

PREGABALIN

Application Number

209357

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 209357

Drug Name

PREGABALIN

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2019-07-19

209357 / 5

Active Ingredient

PREGABALIN

Application Number

209357

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 209357

Drug Name

PREGABALIN

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2019-07-19

209357 / 6

Active Ingredient

PREGABALIN

Application Number

209357

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 209357

Drug Name

PREGABALIN

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2019-07-19

209357 / 7

Active Ingredient

PREGABALIN

Application Number

209357

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 209357

Drug Name

PREGABALIN

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2019-07-19

209357 / 8

Active Ingredient

PREGABALIN

Application Number

209357

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2019-07-19

Regulatory Status

RX

2021
13 Apr
RX Application: 213226

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

82.5MG

Approval Date

2021-04-13

213226 / 1

Active Ingredient

PREGABALIN

Application Number

213226

Product Number

1

Dosage Form

-

Strength

82.5MG

Approval Date

2021-04-13

Regulatory Status

RX

2021
13 Apr
RX Application: 213226

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

165MG

Approval Date

2021-04-13

213226 / 2

Active Ingredient

PREGABALIN

Application Number

213226

Product Number

2

Dosage Form

-

Strength

165MG

Approval Date

2021-04-13

Regulatory Status

RX

2021
13 Apr
RX Application: 213226

Drug Name

PREGABALIN

Product Number

3

Dosage Form

-

Strength

330MG

Approval Date

2021-04-13

213226 / 3

Active Ingredient

PREGABALIN

Application Number

213226

Product Number

3

Dosage Form

-

Strength

330MG

Approval Date

2021-04-13

Regulatory Status

RX

2025
24 Jun
RX Application: 218177

Drug Name

PRUCALOPRIDE SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2025-06-24

218177 / 1

Active Ingredient

PRUCALOPRIDE SUCCINATE

Application Number

218177

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2025-06-24

Regulatory Status

RX

2025
24 Jun
RX Application: 218177

Drug Name

PRUCALOPRIDE SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2025-06-24

218177 / 2

Active Ingredient

PRUCALOPRIDE SUCCINATE

Application Number

218177

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2025-06-24

Regulatory Status

RX

2023
21 Sep
RX Application: 216512

Drug Name

PYRIDOSTIGMINE BROMIDE

Product Number

1

Dosage Form

-

Strength

60MG/5ML

Approval Date

2023-09-21

216512 / 1

Active Ingredient

PYRIDOSTIGMINE BROMIDE

Application Number

216512

Product Number

1

Dosage Form

-

Strength

60MG/5ML

Approval Date

2023-09-21

Regulatory Status

RX

2022
01 Sep
RX Application: 211135

Drug Name

RIOCIGUAT

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2022-09-01

211135 / 1

Active Ingredient

RIOCIGUAT

Application Number

211135

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2022-09-01

Regulatory Status

RX

2022
01 Sep
RX Application: 211135

Drug Name

RIOCIGUAT

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2022-09-01

211135 / 2

Active Ingredient

RIOCIGUAT

Application Number

211135

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2022-09-01

Regulatory Status

RX

2022
01 Sep
RX Application: 211135

Drug Name

RIOCIGUAT

Product Number

3

Dosage Form

-

Strength

1.5MG

Approval Date

2022-09-01

211135 / 3

Active Ingredient

RIOCIGUAT

Application Number

211135

Product Number

3

Dosage Form

-

Strength

1.5MG

Approval Date

2022-09-01

Regulatory Status

RX

2022
01 Sep
RX Application: 211135

Drug Name

RIOCIGUAT

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2022-09-01

211135 / 4

Active Ingredient

RIOCIGUAT

Application Number

211135

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2022-09-01

Regulatory Status

RX

2022
01 Sep
RX Application: 211135

Drug Name

RIOCIGUAT

Product Number

5

Dosage Form

-

Strength

2.5MG

Approval Date

2022-09-01

211135 / 5

Active Ingredient

RIOCIGUAT

Application Number

211135

Product Number

5

Dosage Form

-

Strength

2.5MG

Approval Date

2022-09-01

Regulatory Status

RX

2025
24 Oct
RX Application: 208546

Drug Name

RIVAROXABAN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2025-10-24

208546 / 1

Active Ingredient

RIVAROXABAN

Application Number

208546

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2025-10-24

Regulatory Status

RX

2025
24 Oct
Discontinued Application: 208546

Drug Name

RIVAROXABAN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2025-10-24

208546 / 2

Active Ingredient

RIVAROXABAN

Application Number

208546

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2025-10-24

Regulatory Status

Discontinued

2025
24 Oct
Discontinued Application: 208546

Drug Name

RIVAROXABAN

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2025-10-24

208546 / 3

Active Ingredient

RIVAROXABAN

Application Number

208546

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2025-10-24

Regulatory Status

Discontinued

2025
24 Oct
Discontinued Application: 208546

Drug Name

RIVAROXABAN

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2025-10-24

208546 / 4

Active Ingredient

RIVAROXABAN

Application Number

208546

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2025-10-24

Regulatory Status

Discontinued

2022
07 Sep
RX Application: 208256

Drug Name

ROFLUMILAST

Product Number

1

Dosage Form

-

Strength

250MCG

Approval Date

2022-09-07

208256 / 1

Active Ingredient

ROFLUMILAST

Application Number

208256

Product Number

1

Dosage Form

-

Strength

250MCG

Approval Date

2022-09-07

Regulatory Status

RX

2022
07 Sep
RX Application: 208256

Drug Name

ROFLUMILAST

Product Number

2

Dosage Form

-

Strength

500MCG

Approval Date

2022-09-07

208256 / 2

Active Ingredient

ROFLUMILAST

Application Number

208256

Product Number

2

Dosage Form

-

Strength

500MCG

Approval Date

2022-09-07

Regulatory Status

RX

2017
22 Nov
RX Application: 208898

Drug Name

ROSUVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2017-11-22

208898 / 1

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

208898

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2017-11-22

Regulatory Status

RX

2017
22 Nov
RX Application: 208898

Drug Name

ROSUVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2017-11-22

208898 / 2

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

208898

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2017-11-22

Regulatory Status

RX

2017
22 Nov
RX Application: 208898

Drug Name

ROSUVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2017-11-22

208898 / 3

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

208898

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2017-11-22

Regulatory Status

RX

2017
22 Nov
RX Application: 208898

Drug Name

ROSUVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2017-11-22

208898 / 4

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

208898

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2017-11-22

Regulatory Status

RX

2025
15 Apr
RX Application: 214817

Drug Name

RUFINAMIDE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2025-04-15

214817 / 1

Active Ingredient

RUFINAMIDE

Application Number

214817

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2025-04-15

Regulatory Status

RX

2025
16 Jul
RX Application: 213748

Drug Name

SACUBITRIL AND VALSARTAN

Product Number

1

Dosage Form

-

Strength

24MG;26MG

Approval Date

2025-07-16

213748 / 1

Active Ingredient

SACUBITRIL; VALSARTAN

Application Number

213748

Product Number

1

Dosage Form

-

Strength

24MG;26MG

Approval Date

2025-07-16

Regulatory Status

RX

2025
16 Jul
RX Application: 213748

Drug Name

SACUBITRIL AND VALSARTAN

Product Number

2

Dosage Form

-

Strength

49MG;51MG

Approval Date

2025-07-16

213748 / 2

Active Ingredient

SACUBITRIL; VALSARTAN

Application Number

213748

Product Number

2

Dosage Form

-

Strength

49MG;51MG

Approval Date

2025-07-16

Regulatory Status

RX

2025
16 Jul
RX Application: 213748

Drug Name

SACUBITRIL AND VALSARTAN

Product Number

3

Dosage Form

-

Strength

97MG;103MG

Approval Date

2025-07-16

213748 / 3

Active Ingredient

SACUBITRIL; VALSARTAN

Application Number

213748

Product Number

3

Dosage Form

-

Strength

97MG;103MG

Approval Date

2025-07-16

Regulatory Status

RX

2024
31 Dec
RX Application: 215978

Drug Name

SAFINAMIDE MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2024-12-31

215978 / 1

Active Ingredient

SAFINAMIDE MESYLATE

Application Number

215978

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2024-12-31

Regulatory Status

RX

2024
31 Dec
RX Application: 215978

Drug Name

SAFINAMIDE MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2024-12-31

215978 / 2

Active Ingredient

SAFINAMIDE MESYLATE

Application Number

215978

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2024-12-31

Regulatory Status

RX

-
Unclassified Application: 214367

Drug Name

SELEXIPAG

Product Number

1

Dosage Form

-

Strength

0.2MG

Approval Date

-

214367 / 1

Active Ingredient

SELEXIPAG

Application Number

214367

Product Number

1

Dosage Form

-

Strength

0.2MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214367

Drug Name

SELEXIPAG

Product Number

2

Dosage Form

-

Strength

0.4MG

Approval Date

-

214367 / 2

Active Ingredient

SELEXIPAG

Application Number

214367

Product Number

2

Dosage Form

-

Strength

0.4MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214367

Drug Name

SELEXIPAG

Product Number

3

Dosage Form

-

Strength

0.6MG

Approval Date

-

214367 / 3

Active Ingredient

SELEXIPAG

Application Number

214367

Product Number

3

Dosage Form

-

Strength

0.6MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214367

Drug Name

SELEXIPAG

Product Number

4

Dosage Form

-

Strength

0.8MG

Approval Date

-

214367 / 4

Active Ingredient

SELEXIPAG

Application Number

214367

Product Number

4

Dosage Form

-

Strength

0.8MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214367

Drug Name

SELEXIPAG

Product Number

5

Dosage Form

-

Strength

1MG

Approval Date

-

214367 / 5

Active Ingredient

SELEXIPAG

Application Number

214367

Product Number

5

Dosage Form

-

Strength

1MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214367

Drug Name

SELEXIPAG

Product Number

6

Dosage Form

-

Strength

1.2MG

Approval Date

-

214367 / 6

Active Ingredient

SELEXIPAG

Application Number

214367

Product Number

6

Dosage Form

-

Strength

1.2MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214367

Drug Name

SELEXIPAG

Product Number

7

Dosage Form

-

Strength

1.4MG

Approval Date

-

214367 / 7

Active Ingredient

SELEXIPAG

Application Number

214367

Product Number

7

Dosage Form

-

Strength

1.4MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214367

Drug Name

SELEXIPAG

Product Number

8

Dosage Form

-

Strength

1.6MG

Approval Date

-

214367 / 8

Active Ingredient

SELEXIPAG

Application Number

214367

Product Number

8

Dosage Form

-

Strength

1.6MG

Approval Date

-

Regulatory Status

Unclassified

2022
08 Feb
RX Application: 214641

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2022-02-08

214641 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

214641

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2022-02-08

Regulatory Status

RX

2018
03 Dec
RX Application: 210687

Drug Name

SILODOSIN

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2018-12-03

210687 / 1

Active Ingredient

SILODOSIN

Application Number

210687

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2018-12-03

Regulatory Status

RX

2018
03 Dec
RX Application: 210687

Drug Name

SILODOSIN

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2018-12-03

210687 / 2

Active Ingredient

SILODOSIN

Application Number

210687

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2018-12-03

Regulatory Status

RX

2023
19 Jan
RX Application: 216728

Drug Name

SIROLIMUS

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2023-01-19

216728 / 1

Active Ingredient

SIROLIMUS

Application Number

216728

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2023-01-19

Regulatory Status

RX

-
Unclassified Application: 216086

Drug Name

SITAGLIPTIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

-

216086 / 2

Active Ingredient

SITAGLIPTIN PHOSPHATE

Application Number

216086

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 216086

Drug Name

SITAGLIPTIN

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

-

216086 / 3

Active Ingredient

SITAGLIPTIN PHOSPHATE

Application Number

216086

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 216288

Drug Name

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

-

216288 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE, SITAGLIPTIN

Application Number

216288

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 216288

Drug Name

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

-

216288 / 3

Active Ingredient

METFORMIN HYDROCHLORIDE, SITAGLIPTIN

Application Number

216288

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 217395

Drug Name

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

217395 / 2

Active Ingredient

SITAGLIPTIN PHOSPHATE ANHYDROUS, METFORMIN HYDROCHLORIDE

Application Number

217395

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 217395

Drug Name

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

-

217395 / 3

Active Ingredient

SITAGLIPTIN PHOSPHATE ANHYDROUS, METFORMIN HYDROCHLORIDE

Application Number

217395

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 217395

Drug Name

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

50MG

Approval Date

-

217395 / 4

Active Ingredient

SITAGLIPTIN PHOSPHATE ANHYDROUS, METFORMIN HYDROCHLORIDE

Application Number

217395

Product Number

4

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

2019
20 May
RX Application: 210688

Drug Name

SOLIFENACIN SUCCINATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-05-20

210688 / 1

Active Ingredient

SOLIFENACIN SUCCINATE

Application Number

210688

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-05-20

Regulatory Status

RX

2019
20 May
RX Application: 210688

Drug Name

SOLIFENACIN SUCCINATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-05-20

210688 / 2

Active Ingredient

SOLIFENACIN SUCCINATE

Application Number

210688

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-05-20

Regulatory Status

RX

2026
28 Jul
RX Application: 214368

Drug Name

SUGAMMADEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/2ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

214368 / 1

Active Ingredient

SUGAMMADEX SODIUM

Application Number

214368

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/2ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

Regulatory Status

RX

2026
28 Jul
RX Application: 214368

Drug Name

SUGAMMADEX SODIUM

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2026-07-28

214368 / 2

Active Ingredient

SUGAMMADEX SODIUM

Application Number

214368

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2026-07-28

Regulatory Status

RX

2025
14 Feb
RX Application: 214824

Drug Name

SUNITINIB MALATE

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE

Approval Date

2025-02-14

214824 / 1

Active Ingredient

SUNITINIB MALATE

Application Number

214824

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE

Approval Date

2025-02-14

Regulatory Status

RX

2025
14 Feb
RX Application: 214824

Drug Name

SUNITINIB MALATE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2025-02-14

214824 / 2

Active Ingredient

SUNITINIB MALATE

Application Number

214824

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2025-02-14

Regulatory Status

RX

2025
14 Feb
RX Application: 214824

Drug Name

SUNITINIB MALATE

Product Number

3

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2025-02-14

214824 / 3

Active Ingredient

SUNITINIB MALATE

Application Number

214824

Product Number

3

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2025-02-14

Regulatory Status

RX

2025
14 Feb
RX Application: 214824

Drug Name

SUNITINIB MALATE

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2025-02-14

214824 / 4

Active Ingredient

SUNITINIB MALATE

Application Number

214824

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2025-02-14

Regulatory Status

RX

2023
12 Jan
RX Application: 211654

Drug Name

TASIMELTEON

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2023-01-12

211654 / 1

Active Ingredient

TASIMELTEON

Application Number

211654

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2023-01-12

Regulatory Status

RX

2019
24 Apr
RX Application: 209623

Drug Name

TERIFLUNOMIDE

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

2019-04-24

209623 / 1

Active Ingredient

TERIFLUNOMIDE

Application Number

209623

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

2019-04-24

Regulatory Status

RX

2019
24 Apr
RX Application: 209623

Drug Name

TERIFLUNOMIDE

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

2019-04-24

209623 / 2

Active Ingredient

TERIFLUNOMIDE

Application Number

209623

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

2019-04-24

Regulatory Status

RX

2020
04 Mar
RX Application: 213049

Drug Name

THIOTEPA

Product Number

1

Dosage Form

-

Strength

15MG/VIAL

Approval Date

2020-03-04

213049 / 1

Active Ingredient

THIOTEPA

Application Number

213049

Product Number

1

Dosage Form

-

Strength

15MG/VIAL

Approval Date

2020-03-04

Regulatory Status

RX

2020
04 Mar
RX Application: 213049

Drug Name

THIOTEPA

Product Number

2

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2020-03-04

213049 / 2

Active Ingredient

THIOTEPA

Application Number

213049

Product Number

2

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2020-03-04

Regulatory Status

RX

2021
16 Nov
RX Application: 214816

Drug Name

TIAGABINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2021-11-16

214816 / 1

Active Ingredient

TIAGABINE HYDROCHLORIDE

Application Number

214816

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2021-11-16

Regulatory Status

RX

2021
16 Nov
RX Application: 214816

Drug Name

TIAGABINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2021-11-16

214816 / 2

Active Ingredient

TIAGABINE HYDROCHLORIDE

Application Number

214816

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2021-11-16

Regulatory Status

RX

2021
16 Nov
RX Application: 214816

Drug Name

TIAGABINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

12MG

Approval Date

2021-11-16

214816 / 3

Active Ingredient

TIAGABINE HYDROCHLORIDE

Application Number

214816

Product Number

3

Dosage Form

-

Strength

12MG

Approval Date

2021-11-16

Regulatory Status

RX

2021
16 Nov
RX Application: 214816

Drug Name

TIAGABINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

16MG

Approval Date

2021-11-16

214816 / 4

Active Ingredient

TIAGABINE HYDROCHLORIDE

Application Number

214816

Product Number

4

Dosage Form

-

Strength

16MG

Approval Date

2021-11-16

Regulatory Status

RX

2020
07 Apr
RX Application: 208596

Drug Name

TICAGRELOR

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2020-04-07

208596 / 1

Active Ingredient

TICAGRELOR

Application Number

208596

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2020-04-07

Regulatory Status

RX

2025
28 Oct
RX Application: 208596

Drug Name

TICAGRELOR

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2025-10-28

208596 / 2

Active Ingredient

TICAGRELOR

Application Number

208596

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2025-10-28

Regulatory Status

RX

2025
08 Jan
RX Application: 214024

Drug Name

TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE

Product Number

1

Dosage Form

-

Strength

EQ 6.14MG BASE;15MG

Approval Date

2025-01-08

214024 / 1

Active Ingredient

TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

Application Number

214024

Product Number

1

Dosage Form

-

Strength

EQ 6.14MG BASE;15MG

Approval Date

2025-01-08

Regulatory Status

RX

2025
08 Jan
RX Application: 214024

Drug Name

TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE

Product Number

2

Dosage Form

-

Strength

EQ 8.19MG BASE;20MG

Approval Date

2025-01-08

214024 / 2

Active Ingredient

TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

Application Number

214024

Product Number

2

Dosage Form

-

Strength

EQ 8.19MG BASE;20MG

Approval Date

2025-01-08

Regulatory Status

RX

2026
03 Jun
RX Application: 217298

Drug Name

TOFACITINIB CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2026-06-03

217298 / 1

Active Ingredient

TOFACITINIB CITRATE

Application Number

217298

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2026-06-03

Regulatory Status

RX

2026
03 Jun
RX Application: 217299

Drug Name

TOFACITINIB CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2026-06-03

217299 / 1

Active Ingredient

TOFACITINIB CITRATE

Application Number

217299

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2026-06-03

Regulatory Status

RX

2026
03 Jun
RX Application: 217299

Drug Name

TOFACITINIB CITRATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2026-06-03

217299 / 2

Active Ingredient

TOFACITINIB CITRATE

Application Number

217299

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2026-06-03

Regulatory Status

RX

2023
21 Jun
RX Application: 216949

Drug Name

TOLVAPTAN

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2023-06-21

216949 / 1

Active Ingredient

TOLVAPTAN

Application Number

216949

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2023-06-21

Regulatory Status

RX

2023
21 Jun
RX Application: 216949

Drug Name

TOLVAPTAN

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2023-06-21

216949 / 2

Active Ingredient

TOLVAPTAN

Application Number

216949

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2023-06-21

Regulatory Status

RX

2020
18 Aug
RX Application: 212818

Drug Name

TOREMIFENE CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2020-08-18

212818 / 1

Active Ingredient

TOREMIFENE CITRATE

Application Number

212818

Product Number

1

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2020-08-18

Regulatory Status

RX

2019
22 May
RX Application: 211134

Drug Name

TRIENTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2019-05-22

211134 / 1

Active Ingredient

TRIENTINE HYDROCHLORIDE

Application Number

211134

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2019-05-22

Regulatory Status

RX

-
Unclassified Application: 219218

Drug Name

UBROGEPANT

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

219218 / 1

Active Ingredient

UBROGEPANT

Application Number

219218

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 219218

Drug Name

UBROGEPANT

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

219218 / 2

Active Ingredient

UBROGEPANT

Application Number

219218

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

2022
17 Feb
RX Application: 210169

Drug Name

VALGANCICLOVIR HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2022-02-17

210169 / 1

Active Ingredient

VALGANCICLOVIR HYDROCHLORIDE

Application Number

210169

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2022-02-17

Regulatory Status

RX

2022
07 Sep
RX Application: 215363

Drug Name

VIGABATRIN

Product Number

1

Dosage Form

-

Strength

500MG/PACKET

Approval Date

2022-09-07

215363 / 1

Active Ingredient

VIGABATRIN

Application Number

215363

Product Number

1

Dosage Form

-

Strength

500MG/PACKET

Approval Date

2022-09-07

Regulatory Status

RX

-
Unclassified Application: 211101

Drug Name

VORTIOXETINE HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

211101 / 2

Active Ingredient

VORTIOXETINE HYDROBROMIDE

Application Number

211101

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 211101

Drug Name

VORTIOXETINE HYDROBROMIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

-

211101 / 3

Active Ingredient

VORTIOXETINE HYDROBROMIDE

Application Number

211101

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

-

Regulatory Status

Unclassified

2022
15 Sep
RX Application: 216091

Drug Name

ZIPRASIDONE MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/VIAL

Approval Date

2022-09-15

216091 / 1

Active Ingredient

ZIPRASIDONE MESYLATE

Application Number

216091

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/VIAL

Approval Date

2022-09-15

Regulatory Status

RX

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Drug Status Breakdown
287 total
  • RX
  • Unclassified
  • Discontinued
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

ABIRATERONE ACETATE

Application Number

210686

Product Number

1

Active Ingredient

ABIRATERONE ACETATE

Dosage Form

-

Strength

250MG

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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