Alkem Laboratories RX
FDA Approved Drugs

Alkem Laboratories RX

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
  • Total Records 345
  • Latest Approval Date Jun 17, 2026
  • Data Source FDA
  • First Approval Date May 31, 1985
All
357
View
Unclassified
2
View
Discontinued
10
View
RX
345
View
Company Overview

Company

Alkem Laboratories RX

Country

India

Website

Visit Website

Email

contact@alkem.com

Social Profiles

LinkedIn X / Twitter
Company Snapshot

Alkem Laboratories RX

Devashish Building, Alkem House, Senapati Bapat Road, Lower Parel, Mumbai - 400 013

India

www.alkemlabs.com/ contact@alkem.com View on Map
FDA Approved Drug Records ( 345 records )
2017
14 Aug
RX Application: 209042

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;20MG

Approval Date

2017-08-14

209042 / 1

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

209042

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;20MG

Approval Date

2017-08-14

Regulatory Status

RX

2017
14 Aug
RX Application: 209042

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;40MG

Approval Date

2017-08-14

209042 / 2

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

209042

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;40MG

Approval Date

2017-08-14

Regulatory Status

RX

2017
14 Aug
RX Application: 209042

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;20MG

Approval Date

2017-08-14

209042 / 3

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

209042

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;20MG

Approval Date

2017-08-14

Regulatory Status

RX

2017
14 Aug
RX Application: 209042

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;40MG

Approval Date

2017-08-14

209042 / 4

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

209042

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;40MG

Approval Date

2017-08-14

Regulatory Status

RX

2009
04 May
RX Application: 78925

Drug Name

AMLODIPINE BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2009-05-04

78925 / 1

Active Ingredient

AMLODIPINE BESYLATE

Application Number

78925

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2009-05-04

Regulatory Status

RX

2009
04 May
RX Application: 78925

Drug Name

AMLODIPINE BESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2009-05-04

78925 / 2

Active Ingredient

AMLODIPINE BESYLATE

Application Number

78925

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2009-05-04

Regulatory Status

RX

2009
04 May
RX Application: 78925

Drug Name

AMLODIPINE BESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2009-05-04

78925 / 3

Active Ingredient

AMLODIPINE BESYLATE

Application Number

78925

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2009-05-04

Regulatory Status

RX

2020
27 Oct
RX Application: 213720

Drug Name

AMPHETAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2020-10-27

213720 / 1

Active Ingredient

AMPHETAMINE SULFATE

Application Number

213720

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2020-10-27

Regulatory Status

RX

2020
27 Oct
RX Application: 213720

Drug Name

AMPHETAMINE SULFATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2020-10-27

213720 / 2

Active Ingredient

AMPHETAMINE SULFATE

Application Number

213720

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2020-10-27

Regulatory Status

RX

2021
21 Sep
RX Application: 211761

Drug Name

APREMILAST

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-09-21

211761 / 1

Active Ingredient

APREMILAST

Application Number

211761

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-09-21

Regulatory Status

RX

2021
21 Sep
RX Application: 211761

Drug Name

APREMILAST

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2021-09-21

211761 / 2

Active Ingredient

APREMILAST

Application Number

211761

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2021-09-21

Regulatory Status

RX

2021
21 Sep
RX Application: 211761

Drug Name

APREMILAST

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2021-09-21

211761 / 3

Active Ingredient

APREMILAST

Application Number

211761

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2021-09-21

Regulatory Status

RX

2019
21 Feb
RX Application: 207105

Drug Name

ARIPIPRAZOLE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2019-02-21

207105 / 1

Active Ingredient

ARIPIPRAZOLE

Application Number

207105

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2019-02-21

Regulatory Status

RX

2019
21 Feb
RX Application: 207105

Drug Name

ARIPIPRAZOLE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-02-21

207105 / 2

Active Ingredient

ARIPIPRAZOLE

Application Number

207105

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-02-21

Regulatory Status

RX

2019
21 Feb
RX Application: 207105

Drug Name

ARIPIPRAZOLE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2019-02-21

207105 / 3

Active Ingredient

ARIPIPRAZOLE

Application Number

207105

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2019-02-21

Regulatory Status

RX

2019
21 Feb
RX Application: 207105

Drug Name

ARIPIPRAZOLE

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2019-02-21

207105 / 4

Active Ingredient

ARIPIPRAZOLE

Application Number

207105

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2019-02-21

Regulatory Status

RX

2019
21 Feb
RX Application: 207105

Drug Name

ARIPIPRAZOLE

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2019-02-21

207105 / 5

Active Ingredient

ARIPIPRAZOLE

Application Number

207105

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2019-02-21

Regulatory Status

RX

2019
21 Feb
RX Application: 207105

Drug Name

ARIPIPRAZOLE

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2019-02-21

207105 / 6

Active Ingredient

ARIPIPRAZOLE

Application Number

207105

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2019-02-21

Regulatory Status

RX

2018
21 Dec
RX Application: 209288

Drug Name

ATORVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2018-12-21

209288 / 1

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

209288

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2018-12-21

Regulatory Status

RX

2018
21 Dec
RX Application: 209288

Drug Name

ATORVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2018-12-21

209288 / 2

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

209288

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2018-12-21

Regulatory Status

RX

2018
21 Dec
RX Application: 209288

Drug Name

ATORVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2018-12-21

209288 / 3

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

209288

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2018-12-21

Regulatory Status

RX

2018
21 Dec
RX Application: 209288

Drug Name

ATORVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2018-12-21

209288 / 4

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

209288

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2018-12-21

Regulatory Status

RX

2020
27 Mar
RX Application: 208687

Drug Name

AZATHIOPRINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2020-03-27

208687 / 1

Active Ingredient

AZATHIOPRINE

Application Number

208687

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2020-03-27

Regulatory Status

RX

2020
27 Mar
RX Application: 208687

Drug Name

AZATHIOPRINE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2020-03-27

208687 / 2

Active Ingredient

AZATHIOPRINE

Application Number

208687

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2020-03-27

Regulatory Status

RX

2020
27 Mar
RX Application: 208687

Drug Name

AZATHIOPRINE

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2020-03-27

208687 / 3

Active Ingredient

AZATHIOPRINE

Application Number

208687

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2020-03-27

Regulatory Status

RX

2020
27 Mar
RX Application: 208687

Drug Name

AZATHIOPRINE

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2020-03-27

208687 / 4

Active Ingredient

AZATHIOPRINE

Application Number

208687

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2020-03-27

Regulatory Status

RX

2017
18 Aug
RX Application: 208156

Drug Name

AZELASTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.137MG/SPRAY

Approval Date

2017-08-18

208156 / 1

Active Ingredient

AZELASTINE HYDROCHLORIDE

Application Number

208156

Product Number

1

Dosage Form

-

Strength

0.137MG/SPRAY

Approval Date

2017-08-18

Regulatory Status

RX

2025
21 Jan
RX Application: 217490

Drug Name

AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE

Product Number

1

Dosage Form

-

Strength

EQ 40MG MEDOXOMIL;12.5MG

Approval Date

2025-01-21

217490 / 1

Active Ingredient

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

Application Number

217490

Product Number

1

Dosage Form

-

Strength

EQ 40MG MEDOXOMIL;12.5MG

Approval Date

2025-01-21

Regulatory Status

RX

2025
21 Jan
RX Application: 217490

Drug Name

AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE

Product Number

2

Dosage Form

-

Strength

EQ 40MG MEDOXOMIL;25MG

Approval Date

2025-01-21

217490 / 2

Active Ingredient

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

Application Number

217490

Product Number

2

Dosage Form

-

Strength

EQ 40MG MEDOXOMIL;25MG

Approval Date

2025-01-21

Regulatory Status

RX

2026
23 Feb
RX Application: 219772

Drug Name

BRIVARACETAM

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2026-02-23

219772 / 1

Active Ingredient

BRIVARACETAM

Application Number

219772

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2026-02-23

Regulatory Status

RX

2020
14 Jul
RX Application: 210647

Drug Name

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2020-07-14

210647 / 1

Active Ingredient

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

210647

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2020-07-14

Regulatory Status

RX

2021
15 Jun
RX Application: 214930

Drug Name

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE;EQ 0.5MG BASE

Approval Date

2021-06-15

214930 / 1

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

214930

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE;EQ 0.5MG BASE

Approval Date

2021-06-15

Regulatory Status

RX

2021
15 Jun
RX Application: 214930

Drug Name

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE;EQ 2MG BASE

Approval Date

2021-06-15

214930 / 2

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

214930

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE;EQ 2MG BASE

Approval Date

2021-06-15

Regulatory Status

RX

2017
24 Nov
RX Application: 207652

Drug Name

CAPECITABINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2017-11-24

207652 / 1

Active Ingredient

CAPECITABINE

Application Number

207652

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2017-11-24

Regulatory Status

RX

2017
24 Nov
RX Application: 207652

Drug Name

CAPECITABINE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2017-11-24

207652 / 2

Active Ingredient

CAPECITABINE

Application Number

207652

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2017-11-24

Regulatory Status

RX

2025
14 Jan
RX Application: 217277

Drug Name

CARBAMAZEPINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2025-01-14

217277 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

217277

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2025-01-14

Regulatory Status

RX

2025
14 Jan
RX Application: 217277

Drug Name

CARBAMAZEPINE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2025-01-14

217277 / 2

Active Ingredient

CARBAMAZEPINE

Application Number

217277

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2025-01-14

Regulatory Status

RX

2025
14 Jan
RX Application: 217277

Drug Name

CARBAMAZEPINE

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2025-01-14

217277 / 3

Active Ingredient

CARBAMAZEPINE

Application Number

217277

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2025-01-14

Regulatory Status

RX

2021
19 Feb
RX Application: 210220

Drug Name

CEFDINIR

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2021-02-19

210220 / 1

Active Ingredient

CEFDINIR

Application Number

210220

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2021-02-19

Regulatory Status

RX

2021
19 Feb
RX Application: 210534

Drug Name

CEFDINIR

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

2021-02-19

210534 / 1

Active Ingredient

CEFDINIR

Application Number

210534

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

2021-02-19

Regulatory Status

RX

2021
19 Feb
RX Application: 210534

Drug Name

CEFDINIR

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

2021-02-19

210534 / 2

Active Ingredient

CEFDINIR

Application Number

210534

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

2021-02-19

Regulatory Status

RX

2018
09 Oct
RX Application: 210574

Drug Name

CEFIXIME

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2018-10-09

210574 / 1

Active Ingredient

CEFIXIME

Application Number

210574

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2018-10-09

Regulatory Status

RX

2021
19 Feb
RX Application: 211775

Drug Name

CEFIXIME

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2021-02-19

211775 / 1

Active Ingredient

CEFIXIME

Application Number

211775

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2021-02-19

Regulatory Status

RX

2021
19 Feb
RX Application: 211775

Drug Name

CEFIXIME

Product Number

2

Dosage Form

-

Strength

200MG/5ML

Approval Date

2021-02-19

211775 / 2

Active Ingredient

CEFIXIME

Application Number

211775

Product Number

2

Dosage Form

-

Strength

200MG/5ML

Approval Date

2021-02-19

Regulatory Status

RX

2022
18 May
RX Application: 210568

Drug Name

CEFPODOXIME PROXETIL

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2022-05-18

210568 / 1

Active Ingredient

CEFPODOXIME PROXETIL

Application Number

210568

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2022-05-18

Regulatory Status

RX

2022
18 May
RX Application: 210568

Drug Name

CEFPODOXIME PROXETIL

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2022-05-18

210568 / 2

Active Ingredient

CEFPODOXIME PROXETIL

Application Number

210568

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2022-05-18

Regulatory Status

RX

2024
09 Apr
RX Application: 90857

Drug Name

CEFPROZIL

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2024-04-09

90857 / 1

Active Ingredient

CEFPROZIL

Application Number

90857

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2024-04-09

Regulatory Status

RX

2024
09 Apr
RX Application: 90857

Drug Name

CEFPROZIL

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2024-04-09

90857 / 2

Active Ingredient

CEFPROZIL

Application Number

90857

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2024-04-09

Regulatory Status

RX

2010
07 Jun
RX Application: 65496

Drug Name

CEFUROXIME AXETIL

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2010-06-07

65496 / 1

Active Ingredient

CEFUROXIME AXETIL

Application Number

65496

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2010-06-07

Regulatory Status

RX

2010
07 Jun
RX Application: 65496

Drug Name

CEFUROXIME AXETIL

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2010-06-07

65496 / 2

Active Ingredient

CEFUROXIME AXETIL

Application Number

65496

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2010-06-07

Regulatory Status

RX

2010
20 Dec
RX Application: 90836

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2010-12-20

90836 / 1

Active Ingredient

CEPHALEXIN

Application Number

90836

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2010-12-20

Regulatory Status

RX

2010
20 Dec
RX Application: 90836

Drug Name

CEPHALEXIN

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2010-12-20

90836 / 2

Active Ingredient

CEPHALEXIN

Application Number

90836

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2010-12-20

Regulatory Status

RX

2013
29 Mar
RX Application: 90836

Drug Name

CEPHALEXIN

Product Number

3

Dosage Form

-

Strength

EQ 333MG BASE

Approval Date

2013-03-29

90836 / 3

Active Ingredient

CEPHALEXIN

Application Number

90836

Product Number

3

Dosage Form

-

Strength

EQ 333MG BASE

Approval Date

2013-03-29

Regulatory Status

RX

2013
29 Mar
RX Application: 90836

Drug Name

CEPHALEXIN

Product Number

4

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2013-03-29

90836 / 4

Active Ingredient

CEPHALEXIN

Application Number

90836

Product Number

4

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2013-03-29

Regulatory Status

RX

2019
26 Mar
RX Application: 210221

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

2019-03-26

210221 / 1

Active Ingredient

CEPHALEXIN

Application Number

210221

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

2019-03-26

Regulatory Status

RX

2019
26 Mar
RX Application: 210221

Drug Name

CEPHALEXIN

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

2019-03-26

210221 / 2

Active Ingredient

CEPHALEXIN

Application Number

210221

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

2019-03-26

Regulatory Status

RX

2024
27 Sep
RX Application: 218947

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2024-09-27

218947 / 1

Active Ingredient

CEPHALEXIN

Application Number

218947

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2024-09-27

Regulatory Status

RX

2024
27 Sep
RX Application: 218947

Drug Name

CEPHALEXIN

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2024-09-27

218947 / 2

Active Ingredient

CEPHALEXIN

Application Number

218947

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2024-09-27

Regulatory Status

RX

2021
26 Apr
RX Application: 214065

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

5MG;2.5MG

Approval Date

2021-04-26

214065 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE

Application Number

214065

Product Number

1

Dosage Form

-

Strength

5MG;2.5MG

Approval Date

2021-04-26

Regulatory Status

RX

2020
11 Feb
RX Application: 213412

Drug Name

CHLORTHALIDONE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2020-02-11

213412 / 1

Active Ingredient

CHLORTHALIDONE

Application Number

213412

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2020-02-11

Regulatory Status

RX

2020
11 Feb
RX Application: 213412

Drug Name

CHLORTHALIDONE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2020-02-11

213412 / 2

Active Ingredient

CHLORTHALIDONE

Application Number

213412

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2020-02-11

Regulatory Status

RX

2021
19 Oct
RX Application: 211856

Drug Name

CHOLESTYRAMINE

Product Number

1

Dosage Form

-

Strength

EQ 4GM RESIN/PACKET

Approval Date

2021-10-19

211856 / 1

Active Ingredient

CHOLESTYRAMINE

Application Number

211856

Product Number

1

Dosage Form

-

Strength

EQ 4GM RESIN/PACKET

Approval Date

2021-10-19

Regulatory Status

RX

2021
19 Oct
RX Application: 211856

Drug Name

CHOLESTYRAMINE

Product Number

2

Dosage Form

-

Strength

EQ 4GM RESIN/SCOOPFUL

Approval Date

2021-10-19

211856 / 2

Active Ingredient

CHOLESTYRAMINE

Application Number

211856

Product Number

2

Dosage Form

-

Strength

EQ 4GM RESIN/SCOOPFUL

Approval Date

2021-10-19

Regulatory Status

RX

2021
19 Oct
RX Application: 211799

Drug Name

CHOLESTYRAMINE LIGHT

Product Number

1

Dosage Form

-

Strength

EQ 4GM RESIN/PACKET

Approval Date

2021-10-19

211799 / 1

Active Ingredient

CHOLESTYRAMINE

Application Number

211799

Product Number

1

Dosage Form

-

Strength

EQ 4GM RESIN/PACKET

Approval Date

2021-10-19

Regulatory Status

RX

2021
19 Oct
RX Application: 211799

Drug Name

CHOLESTYRAMINE LIGHT

Product Number

2

Dosage Form

-

Strength

EQ 4GM RESIN/SCOOPFUL

Approval Date

2021-10-19

211799 / 2

Active Ingredient

CHOLESTYRAMINE

Application Number

211799

Product Number

2

Dosage Form

-

Strength

EQ 4GM RESIN/SCOOPFUL

Approval Date

2021-10-19

Regulatory Status

RX

2019
17 May
RX Application: 210570

Drug Name

CINACALCET HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2019-05-17

210570 / 1

Active Ingredient

CINACALCET HYDROCHLORIDE

Application Number

210570

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2019-05-17

Regulatory Status

RX

2019
17 May
RX Application: 210570

Drug Name

CINACALCET HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2019-05-17

210570 / 2

Active Ingredient

CINACALCET HYDROCHLORIDE

Application Number

210570

Product Number

2

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2019-05-17

Regulatory Status

RX

2019
17 May
RX Application: 210570

Drug Name

CINACALCET HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 90MG BASE

Approval Date

2019-05-17

210570 / 3

Active Ingredient

CINACALCET HYDROCHLORIDE

Application Number

210570

Product Number

3

Dosage Form

-

Strength

EQ 90MG BASE

Approval Date

2019-05-17

Regulatory Status

RX

2019
06 Sep
RX Application: 212714

Drug Name

CLOBAZAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2019-09-06

212714 / 1

Active Ingredient

CLOBAZAM

Application Number

212714

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2019-09-06

Regulatory Status

RX

2019
06 Sep
RX Application: 212714

Drug Name

CLOBAZAM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2019-09-06

212714 / 2

Active Ingredient

CLOBAZAM

Application Number

212714

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2019-09-06

Regulatory Status

RX

2020
21 Dec
RX Application: 212714

Drug Name

CLOBAZAM

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2020-12-21

212714 / 3

Active Ingredient

CLOBAZAM

Application Number

212714

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2020-12-21

Regulatory Status

RX

2021
06 May
RX Application: 213039

Drug Name

CLOBAZAM

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2021-05-06

213039 / 1

Active Ingredient

CLOBAZAM

Application Number

213039

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2021-05-06

Regulatory Status

RX

2023
08 Dec
RX Application: 203632

Drug Name

CLOPIDOGREL BISULFATE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2023-12-08

203632 / 1

Active Ingredient

CLOPIDOGREL BISULFATE

Application Number

203632

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2023-12-08

Regulatory Status

RX

2019
08 Feb
RX Application: 211250

Drug Name

COLCHICINE

Product Number

1

Dosage Form

-

Strength

0.6MG

Approval Date

2019-02-08

211250 / 1

Active Ingredient

COLCHICINE

Application Number

211250

Product Number

1

Dosage Form

-

Strength

0.6MG

Approval Date

2019-02-08

Regulatory Status

RX

2018
05 Oct
RX Application: 209038

Drug Name

COLESEVELAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

625MG

Approval Date

2018-10-05

209038 / 1

Active Ingredient

COLESEVELAM HYDROCHLORIDE

Application Number

209038

Product Number

1

Dosage Form

-

Strength

625MG

Approval Date

2018-10-05

Regulatory Status

RX

2019
06 May
RX Application: 210316

Drug Name

COLESEVELAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

3.75GM/PACKET

Approval Date

2019-05-06

210316 / 1

Active Ingredient

COLESEVELAM HYDROCHLORIDE

Application Number

210316

Product Number

1

Dosage Form

-

Strength

3.75GM/PACKET

Approval Date

2019-05-06

Regulatory Status

RX

2020
11 Mar
RX Application: 208040

Drug Name

DABIGATRAN ETEXILATE MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2020-03-11

208040 / 1

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

208040

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2020-03-11

Regulatory Status

RX

2020
11 Mar
RX Application: 208040

Drug Name

DABIGATRAN ETEXILATE MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2020-03-11

208040 / 2

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

208040

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2020-03-11

Regulatory Status

RX

2024
11 Sep
RX Application: 208040

Drug Name

DABIGATRAN ETEXILATE MESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 110MG BASE

Approval Date

2024-09-11

208040 / 3

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

208040

Product Number

3

Dosage Form

-

Strength

EQ 110MG BASE

Approval Date

2024-09-11

Regulatory Status

RX

2018
30 Jul
RX Application: 206765

Drug Name

DALFAMPRIDINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-07-30

206765 / 1

Active Ingredient

DALFAMPRIDINE

Application Number

206765

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-07-30

Regulatory Status

RX

2026
06 Apr
RX Application: 211545

Drug Name

DAPAGLIFLOZIN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2026-04-06

211545 / 1

Active Ingredient

DAPAGLIFLOZIN

Application Number

211545

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211545

Drug Name

DAPAGLIFLOZIN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-04-06

211545 / 2

Active Ingredient

DAPAGLIFLOZIN

Application Number

211545

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211563

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG;500MG

Approval Date

2026-04-06

211563 / 1

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211563

Product Number

1

Dosage Form

-

Strength

5MG;500MG

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211563

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG;1GM

Approval Date

2026-04-06

211563 / 2

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211563

Product Number

2

Dosage Form

-

Strength

5MG;1GM

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211563

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG;500MG

Approval Date

2026-04-06

211563 / 3

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211563

Product Number

3

Dosage Form

-

Strength

10MG;500MG

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211563

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

10MG;1GM

Approval Date

2026-04-06

211563 / 4

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211563

Product Number

4

Dosage Form

-

Strength

10MG;1GM

Approval Date

2026-04-06

Regulatory Status

RX

2019
20 Nov
RX Application: 210519

Drug Name

DEFERASIROX

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2019-11-20

210519 / 1

Active Ingredient

DEFERASIROX

Application Number

210519

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2019-11-20

Regulatory Status

RX

2019
20 Nov
RX Application: 210519

Drug Name

DEFERASIROX

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2019-11-20

210519 / 2

Active Ingredient

DEFERASIROX

Application Number

210519

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2019-11-20

Regulatory Status

RX

2019
20 Nov
RX Application: 210519

Drug Name

DEFERASIROX

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2019-11-20

210519 / 3

Active Ingredient

DEFERASIROX

Application Number

210519

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2019-11-20

Regulatory Status

RX

2020
30 Mar
RX Application: 210555

Drug Name

DEFERASIROX

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2020-03-30

210555 / 1

Active Ingredient

DEFERASIROX

Application Number

210555

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2020-03-30

Regulatory Status

RX

2020
30 Mar
RX Application: 210555

Drug Name

DEFERASIROX

Product Number

2

Dosage Form

-

Strength

360MG

Approval Date

2020-03-30

210555 / 2

Active Ingredient

DEFERASIROX

Application Number

210555

Product Number

2

Dosage Form

-

Strength

360MG

Approval Date

2020-03-30

Regulatory Status

RX

2020
02 Jul
RX Application: 210555

Drug Name

DEFERASIROX

Product Number

3

Dosage Form

-

Strength

180MG

Approval Date

2020-07-02

210555 / 3

Active Ingredient

DEFERASIROX

Application Number

210555

Product Number

3

Dosage Form

-

Strength

180MG

Approval Date

2020-07-02

Regulatory Status

RX

2020
14 Jul
RX Application: 213374

Drug Name

DEFERASIROX

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2020-07-14

213374 / 1

Active Ingredient

DEFERASIROX

Application Number

213374

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2020-07-14

Regulatory Status

RX

2020
14 Jul
RX Application: 213374

Drug Name

DEFERASIROX

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2020-07-14

213374 / 2

Active Ingredient

DEFERASIROX

Application Number

213374

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2020-07-14

Regulatory Status

RX

2020
14 Jul
RX Application: 213374

Drug Name

DEFERASIROX

Product Number

3

Dosage Form

-

Strength

360MG

Approval Date

2020-07-14

213374 / 3

Active Ingredient

DEFERASIROX

Application Number

213374

Product Number

3

Dosage Form

-

Strength

360MG

Approval Date

2020-07-14

Regulatory Status

RX

2019
19 Jul
RX Application: 212631

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2019-07-19

212631 / 1

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

212631

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 212631

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-07-19

212631 / 2

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

212631

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 212631

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2019-07-19

212631 / 3

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

212631

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2019-07-19

Regulatory Status

RX

2023
06 Oct
RX Application: 217787

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2023-10-06

217787 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

217787

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2023-10-06

Regulatory Status

RX

2023
06 Oct
RX Application: 217787

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

2

Dosage Form

-

Strength

1.875MG;1.875MG;1.875MG;1.875MG

Approval Date

2023-10-06

217787 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

217787

Product Number

2

Dosage Form

-

Strength

1.875MG;1.875MG;1.875MG;1.875MG

Approval Date

2023-10-06

Regulatory Status

RX

2023
06 Oct
RX Application: 217787

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

3

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2023-10-06

217787 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

217787

Product Number

3

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2023-10-06

Regulatory Status

RX

2023
06 Oct
RX Application: 217787

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

4

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG

Approval Date

2023-10-06

217787 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

217787

Product Number

4

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG

Approval Date

2023-10-06

Regulatory Status

RX

2023
06 Oct
RX Application: 217787

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

5

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2023-10-06

217787 / 5

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

217787

Product Number

5

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2023-10-06

Regulatory Status

RX

2023
06 Oct
RX Application: 217787

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

6

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2023-10-06

217787 / 6

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

217787

Product Number

6

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2023-10-06

Regulatory Status

RX

2023
06 Oct
RX Application: 217787

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

7

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2023-10-06

217787 / 7

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

217787

Product Number

7

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2023-10-06

Regulatory Status

RX

2022
20 Jul
RX Application: 216635

Drug Name

DICLOFENAC POTASSIUM

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2022-07-20

216635 / 1

Active Ingredient

DICLOFENAC POTASSIUM

Application Number

216635

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2022-07-20

Regulatory Status

RX

2020
24 Sep
RX Application: 210440

Drug Name

DIMETHYL FUMARATE

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2020-09-24

210440 / 1

Active Ingredient

DIMETHYL FUMARATE

Application Number

210440

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2020-09-24

Regulatory Status

RX

2020
24 Sep
RX Application: 210440

Drug Name

DIMETHYL FUMARATE

Product Number

2

Dosage Form

-

Strength

240MG

Approval Date

2020-09-24

210440 / 2

Active Ingredient

DIMETHYL FUMARATE

Application Number

210440

Product Number

2

Dosage Form

-

Strength

240MG

Approval Date

2020-09-24

Regulatory Status

RX

2021
18 Feb
RX Application: 213911

Drug Name

DROXIDOPA

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2021-02-18

213911 / 1

Active Ingredient

DROXIDOPA

Application Number

213911

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2021-02-18

Regulatory Status

RX

2021
18 Feb
RX Application: 213911

Drug Name

DROXIDOPA

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2021-02-18

213911 / 2

Active Ingredient

DROXIDOPA

Application Number

213911

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2021-02-18

Regulatory Status

RX

2021
18 Feb
RX Application: 213911

Drug Name

DROXIDOPA

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2021-02-18

213911 / 3

Active Ingredient

DROXIDOPA

Application Number

213911

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2021-02-18

Regulatory Status

RX

2015
26 Aug
RX Application: 203197

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2015-08-26

203197 / 1

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

203197

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2015-08-26

Regulatory Status

RX

2015
26 Aug
RX Application: 203197

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2015-08-26

203197 / 2

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

203197

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2015-08-26

Regulatory Status

RX

2015
26 Aug
RX Application: 203197

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2015-08-26

203197 / 3

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

203197

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2015-08-26

Regulatory Status

RX

2022
30 Mar
RX Application: 213714

Drug Name

ENALAPRIL MALEATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2022-03-30

213714 / 1

Active Ingredient

ENALAPRIL MALEATE

Application Number

213714

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2022-03-30

Regulatory Status

RX

2022
13 Jul
RX Application: 216066

Drug Name

ERYTHROMYCIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2022-07-13

216066 / 1

Active Ingredient

ERYTHROMYCIN

Application Number

216066

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2022-07-13

Regulatory Status

RX

2022
13 Jul
RX Application: 216066

Drug Name

ERYTHROMYCIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2022-07-13

216066 / 2

Active Ingredient

ERYTHROMYCIN

Application Number

216066

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2022-07-13

Regulatory Status

RX

2023
06 Oct
RX Application: 211199

Drug Name

ESLICARBAZEPINE ACETATE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2023-10-06

211199 / 1

Active Ingredient

ESLICARBAZEPINE ACETATE

Application Number

211199

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2023-10-06

Regulatory Status

RX

2023
06 Oct
RX Application: 211199

Drug Name

ESLICARBAZEPINE ACETATE

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2023-10-06

211199 / 2

Active Ingredient

ESLICARBAZEPINE ACETATE

Application Number

211199

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2023-10-06

Regulatory Status

RX

2023
06 Oct
RX Application: 211199

Drug Name

ESLICARBAZEPINE ACETATE

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2023-10-06

211199 / 3

Active Ingredient

ESLICARBAZEPINE ACETATE

Application Number

211199

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2023-10-06

Regulatory Status

RX

2023
06 Oct
RX Application: 211199

Drug Name

ESLICARBAZEPINE ACETATE

Product Number

4

Dosage Form

-

Strength

800MG

Approval Date

2023-10-06

211199 / 4

Active Ingredient

ESLICARBAZEPINE ACETATE

Application Number

211199

Product Number

4

Dosage Form

-

Strength

800MG

Approval Date

2023-10-06

Regulatory Status

RX

2017
20 Oct
RX Application: 208333

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2017-10-20

208333 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

208333

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2017-10-20

Regulatory Status

RX

2017
20 Oct
RX Application: 208333

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2017-10-20

208333 / 2

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

208333

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2017-10-20

Regulatory Status

RX

2021
26 Nov
RX Application: 214138

Drug Name

EVEROLIMUS

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2021-11-26

214138 / 1

Active Ingredient

EVEROLIMUS

Application Number

214138

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2021-11-26

Regulatory Status

RX

2021
26 Nov
RX Application: 214138

Drug Name

EVEROLIMUS

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2021-11-26

214138 / 2

Active Ingredient

EVEROLIMUS

Application Number

214138

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2021-11-26

Regulatory Status

RX

2021
26 Nov
RX Application: 214138

Drug Name

EVEROLIMUS

Product Number

3

Dosage Form

-

Strength

0.75MG

Approval Date

2021-11-26

214138 / 3

Active Ingredient

EVEROLIMUS

Application Number

214138

Product Number

3

Dosage Form

-

Strength

0.75MG

Approval Date

2021-11-26

Regulatory Status

RX

2021
26 Nov
RX Application: 214138

Drug Name

EVEROLIMUS

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

2021-11-26

214138 / 4

Active Ingredient

EVEROLIMUS

Application Number

214138

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

2021-11-26

Regulatory Status

RX

2017
21 Dec
RX Application: 209234

Drug Name

EZETIMIBE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-12-21

209234 / 1

Active Ingredient

EZETIMIBE

Application Number

209234

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-12-21

Regulatory Status

RX

2017
22 Dec
RX Application: 209222

Drug Name

EZETIMIBE AND SIMVASTATIN

Product Number

1

Dosage Form

-

Strength

10MG;10MG

Approval Date

2017-12-22

209222 / 1

Active Ingredient

EZETIMIBE; SIMVASTATIN

Application Number

209222

Product Number

1

Dosage Form

-

Strength

10MG;10MG

Approval Date

2017-12-22

Regulatory Status

RX

2017
22 Dec
RX Application: 209222

Drug Name

EZETIMIBE AND SIMVASTATIN

Product Number

2

Dosage Form

-

Strength

10MG;20MG

Approval Date

2017-12-22

209222 / 2

Active Ingredient

EZETIMIBE; SIMVASTATIN

Application Number

209222

Product Number

2

Dosage Form

-

Strength

10MG;20MG

Approval Date

2017-12-22

Regulatory Status

RX

2017
22 Dec
RX Application: 209222

Drug Name

EZETIMIBE AND SIMVASTATIN

Product Number

3

Dosage Form

-

Strength

10MG;40MG

Approval Date

2017-12-22

209222 / 3

Active Ingredient

EZETIMIBE; SIMVASTATIN

Application Number

209222

Product Number

3

Dosage Form

-

Strength

10MG;40MG

Approval Date

2017-12-22

Regulatory Status

RX

2017
22 Dec
RX Application: 209222

Drug Name

EZETIMIBE AND SIMVASTATIN

Product Number

4

Dosage Form

-

Strength

10MG;80MG

Approval Date

2017-12-22

209222 / 4

Active Ingredient

EZETIMIBE; SIMVASTATIN

Application Number

209222

Product Number

4

Dosage Form

-

Strength

10MG;80MG

Approval Date

2017-12-22

Regulatory Status

RX

2023
15 May
RX Application: 216400

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

2023-05-15

216400 / 1

Active Ingredient

FAMOTIDINE

Application Number

216400

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

2023-05-15

Regulatory Status

RX

2023
24 Apr
RX Application: 217375

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2023-04-24

217375 / 1

Active Ingredient

FAMOTIDINE

Application Number

217375

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2023-04-24

Regulatory Status

RX

2023
24 Apr
RX Application: 217375

Drug Name

FAMOTIDINE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2023-04-24

217375 / 2

Active Ingredient

FAMOTIDINE

Application Number

217375

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2023-04-24

Regulatory Status

RX

2021
07 Dec
RX Application: 212924

Drug Name

FEBUXOSTAT

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2021-12-07

212924 / 1

Active Ingredient

FEBUXOSTAT

Application Number

212924

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2021-12-07

Regulatory Status

RX

2021
07 Dec
RX Application: 212924

Drug Name

FEBUXOSTAT

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2021-12-07

212924 / 2

Active Ingredient

FEBUXOSTAT

Application Number

212924

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2021-12-07

Regulatory Status

RX

2015
10 Dec
RX Application: 204827

Drug Name

FESOTERODINE FUMARATE

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2015-12-10

204827 / 1

Active Ingredient

FESOTERODINE FUMARATE

Application Number

204827

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2015-12-10

Regulatory Status

RX

2015
10 Dec
RX Application: 204827

Drug Name

FESOTERODINE FUMARATE

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2015-12-10

204827 / 2

Active Ingredient

FESOTERODINE FUMARATE

Application Number

204827

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2015-12-10

Regulatory Status

RX

2017
05 Jan
RX Application: 204304

Drug Name

FINASTERIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2017-01-05

204304 / 1

Active Ingredient

FINASTERIDE

Application Number

204304

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2017-01-05

Regulatory Status

RX

2017
06 Jan
RX Application: 207750

Drug Name

FINASTERIDE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2017-01-06

207750 / 1

Active Ingredient

FINASTERIDE

Application Number

207750

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2017-01-06

Regulatory Status

RX

2020
30 Dec
RX Application: 208004

Drug Name

FINGOLIMOD HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2020-12-30

208004 / 1

Active Ingredient

FINGOLIMOD HYDROCHLORIDE

Application Number

208004

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2020-12-30

Regulatory Status

RX

2021
21 Oct
RX Application: 214554

Drug Name

FOSFOMYCIN TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

EQ 3GM BASE/PACKET

Approval Date

2021-10-21

214554 / 1

Active Ingredient

FOSFOMYCIN TROMETHAMINE

Application Number

214554

Product Number

1

Dosage Form

-

Strength

EQ 3GM BASE/PACKET

Approval Date

2021-10-21

Regulatory Status

RX

2010
17 Dec
RX Application: 90858

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2010-12-17

90858 / 1

Active Ingredient

GABAPENTIN

Application Number

90858

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2010-12-17

Regulatory Status

RX

2010
17 Dec
RX Application: 90858

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2010-12-17

90858 / 2

Active Ingredient

GABAPENTIN

Application Number

90858

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2010-12-17

Regulatory Status

RX

2010
17 Dec
RX Application: 90858

Drug Name

GABAPENTIN

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2010-12-17

90858 / 3

Active Ingredient

GABAPENTIN

Application Number

90858

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2010-12-17

Regulatory Status

RX

2015
23 Dec
RX Application: 206402

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2015-12-23

206402 / 1

Active Ingredient

GABAPENTIN

Application Number

206402

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2015-12-23

Regulatory Status

RX

2015
23 Dec
RX Application: 206402

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2015-12-23

206402 / 2

Active Ingredient

GABAPENTIN

Application Number

206402

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2015-12-23

Regulatory Status

RX

2012
07 Dec
RX Application: 200737

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2012-12-07

200737 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

200737

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2012-12-07

Regulatory Status

RX

2012
07 Dec
RX Application: 200737

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2012-12-07

200737 / 2

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

200737

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2012-12-07

Regulatory Status

RX

2012
07 Dec
RX Application: 200737

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2012-12-07

200737 / 3

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

200737

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2012-12-07

Regulatory Status

RX

2012
07 Dec
RX Application: 200737

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2012-12-07

200737 / 4

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

200737

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2012-12-07

Regulatory Status

RX

2021
13 Sep
RX Application: 214699

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2021-09-13

214699 / 1

Active Ingredient

IBUPROFEN

Application Number

214699

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2021-09-13

Regulatory Status

RX

2021
13 Sep
RX Application: 214699

Drug Name

IBUPROFEN

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2021-09-13

214699 / 2

Active Ingredient

IBUPROFEN

Application Number

214699

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2021-09-13

Regulatory Status

RX

2021
13 Sep
RX Application: 214699

Drug Name

IBUPROFEN

Product Number

3

Dosage Form

-

Strength

800MG

Approval Date

2021-09-13

214699 / 3

Active Ingredient

IBUPROFEN

Application Number

214699

Product Number

3

Dosage Form

-

Strength

800MG

Approval Date

2021-09-13

Regulatory Status

RX

2021
03 Aug
RX Application: 211890

Drug Name

IBUPROFEN AND FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

26.6MG;800MG

Approval Date

2021-08-03

211890 / 1

Active Ingredient

FAMOTIDINE; IBUPROFEN

Application Number

211890

Product Number

1

Dosage Form

-

Strength

26.6MG;800MG

Approval Date

2021-08-03

Regulatory Status

RX

2017
12 Jun
RX Application: 208591

Drug Name

ITRACONAZOLE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2017-06-12

208591 / 1

Active Ingredient

ITRACONAZOLE

Application Number

208591

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2017-06-12

Regulatory Status

RX

2022
19 May
RX Application: 214672

Drug Name

LACOSAMIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2022-05-19

214672 / 1

Active Ingredient

LACOSAMIDE

Application Number

214672

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2022-05-19

Regulatory Status

RX

2022
31 Mar
RX Application: 214695

Drug Name

LACOSAMIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2022-03-31

214695 / 1

Active Ingredient

LACOSAMIDE

Application Number

214695

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2022-03-31

Regulatory Status

RX

2022
31 Mar
RX Application: 214695

Drug Name

LACOSAMIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2022-03-31

214695 / 2

Active Ingredient

LACOSAMIDE

Application Number

214695

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2022-03-31

Regulatory Status

RX

2022
31 Mar
RX Application: 214695

Drug Name

LACOSAMIDE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2022-03-31

214695 / 3

Active Ingredient

LACOSAMIDE

Application Number

214695

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2022-03-31

Regulatory Status

RX

2022
31 Mar
RX Application: 214695

Drug Name

LACOSAMIDE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2022-03-31

214695 / 4

Active Ingredient

LACOSAMIDE

Application Number

214695

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2022-03-31

Regulatory Status

RX

2013
14 Jun
RX Application: 200694

Drug Name

LAMOTRIGINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2013-06-14

200694 / 1

Active Ingredient

LAMOTRIGINE

Application Number

200694

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2013-06-14

Regulatory Status

RX

2013
14 Jun
RX Application: 200694

Drug Name

LAMOTRIGINE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2013-06-14

200694 / 2

Active Ingredient

LAMOTRIGINE

Application Number

200694

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2013-06-14

Regulatory Status

RX

2013
14 Jun
RX Application: 200694

Drug Name

LAMOTRIGINE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2013-06-14

200694 / 3

Active Ingredient

LAMOTRIGINE

Application Number

200694

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2013-06-14

Regulatory Status

RX

2013
14 Jun
RX Application: 200694

Drug Name

LAMOTRIGINE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2013-06-14

200694 / 4

Active Ingredient

LAMOTRIGINE

Application Number

200694

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2013-06-14

Regulatory Status

RX

2019
18 Jan
RX Application: 207394

Drug Name

LANSOPRAZOLE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2019-01-18

207394 / 1

Active Ingredient

LANSOPRAZOLE

Application Number

207394

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2019-01-18

Regulatory Status

RX

2019
18 Jan
RX Application: 207394

Drug Name

LANSOPRAZOLE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2019-01-18

207394 / 2

Active Ingredient

LANSOPRAZOLE

Application Number

207394

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2019-01-18

Regulatory Status

RX

2025
13 Mar
RX Application: 202329

Drug Name

LANTHANUM CARBONATE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2025-03-13

202329 / 1

Active Ingredient

LANTHANUM CARBONATE

Application Number

202329

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2025-03-13

Regulatory Status

RX

2025
13 Mar
RX Application: 202329

Drug Name

LANTHANUM CARBONATE

Product Number

2

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2025-03-13

202329 / 2

Active Ingredient

LANTHANUM CARBONATE

Application Number

202329

Product Number

2

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2025-03-13

Regulatory Status

RX

2025
13 Mar
RX Application: 202329

Drug Name

LANTHANUM CARBONATE

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2025-03-13

202329 / 3

Active Ingredient

LANTHANUM CARBONATE

Application Number

202329

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2025-03-13

Regulatory Status

RX

2022
27 May
RX Application: 216375

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2022-05-27

216375 / 1

Active Ingredient

LEVETIRACETAM

Application Number

216375

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2022-05-27

Regulatory Status

RX

2022
27 May
RX Application: 216375

Drug Name

LEVETIRACETAM

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2022-05-27

216375 / 2

Active Ingredient

LEVETIRACETAM

Application Number

216375

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2022-05-27

Regulatory Status

RX

2022
27 May
RX Application: 216375

Drug Name

LEVETIRACETAM

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2022-05-27

216375 / 3

Active Ingredient

LEVETIRACETAM

Application Number

216375

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2022-05-27

Regulatory Status

RX

2022
27 May
RX Application: 216375

Drug Name

LEVETIRACETAM

Product Number

4

Dosage Form

-

Strength

1GM

Approval Date

2022-05-27

216375 / 4

Active Ingredient

LEVETIRACETAM

Application Number

216375

Product Number

4

Dosage Form

-

Strength

1GM

Approval Date

2022-05-27

Regulatory Status

RX

2017
10 Mar
RX Application: 207810

Drug Name

LIDOCAINE

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2017-03-10

207810 / 1

Active Ingredient

LIDOCAINE

Application Number

207810

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2017-03-10

Regulatory Status

RX

2025
06 Oct
RX Application: 216484

Drug Name

LIDOCAINE

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2025-10-06

216484 / 1

Active Ingredient

LIDOCAINE

Application Number

216484

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2025-10-06

Regulatory Status

RX

2015
21 Dec
RX Application: 205517

Drug Name

LINEZOLID

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2015-12-21

205517 / 1

Active Ingredient

LINEZOLID

Application Number

205517

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2015-12-21

Regulatory Status

RX

2023
25 Aug
RX Application: 217194

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-08-25

217194 / 1

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

217194

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 217194

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2023-08-25

217194 / 2

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

217194

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 217194

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2023-08-25

217194 / 3

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

217194

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 217194

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2023-08-25

217194 / 4

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

217194

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 217194

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2023-08-25

217194 / 5

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

217194

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 217194

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2023-08-25

217194 / 6

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

217194

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 217194

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

7

Dosage Form

-

Strength

70MG

Approval Date

2023-08-25

217194 / 7

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

217194

Product Number

7

Dosage Form

-

Strength

70MG

Approval Date

2023-08-25

Regulatory Status

RX

2022
13 Dec
RX Application: 212244

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2022-12-13

212244 / 1

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

212244

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2022-12-13

Regulatory Status

RX

2022
13 Dec
RX Application: 212244

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2022-12-13

212244 / 2

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

212244

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2022-12-13

Regulatory Status

RX

2022
13 Dec
RX Application: 212244

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2022-12-13

212244 / 3

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

212244

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2022-12-13

Regulatory Status

RX

2022
13 Dec
RX Application: 212244

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2022-12-13

212244 / 4

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

212244

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2022-12-13

Regulatory Status

RX

2022
13 Dec
RX Application: 212244

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

120MG

Approval Date

2022-12-13

212244 / 5

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

212244

Product Number

5

Dosage Form

-

Strength

120MG

Approval Date

2022-12-13

Regulatory Status

RX

1985
31 May
RX Application: 18651

Drug Name

MARINOL

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1985-05-31

18651 / 1

Active Ingredient

DRONABINOL

Application Number

18651

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1985-05-31

Regulatory Status

RX

1985
31 May
RX Application: 18651

Drug Name

MARINOL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1985-05-31

18651 / 2

Active Ingredient

DRONABINOL

Application Number

18651

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1985-05-31

Regulatory Status

RX

1985
31 May
RX Application: 18651

Drug Name

MARINOL

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

1985-05-31

18651 / 3

Active Ingredient

DRONABINOL

Application Number

18651

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

1985-05-31

Regulatory Status

RX

2021
15 Jul
RX Application: 214242

Drug Name

MESALAMINE

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

2021-07-15

214242 / 1

Active Ingredient

MESALAMINE

Application Number

214242

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

2021-07-15

Regulatory Status

RX

2010
01 Nov
RX Application: 91184

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2010-11-01

91184 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

91184

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2010-11-01

Regulatory Status

RX

2010
01 Nov
RX Application: 91184

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2010-11-01

91184 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

91184

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2010-11-01

Regulatory Status

RX

2010
01 Nov
RX Application: 91184

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2010-11-01

91184 / 3

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

91184

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2010-11-01

Regulatory Status

RX

2018
22 Oct
RX Application: 206145

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2018-10-22

206145 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

206145

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2018-10-22

Regulatory Status

RX

2018
22 Oct
RX Application: 206145

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2018-10-22

206145 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

206145

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2018-10-22

Regulatory Status

RX

2020
30 Mar
RX Application: 211647

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2020-03-30

211647 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

211647

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2020-03-30

Regulatory Status

RX

2020
30 Mar
RX Application: 211647

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG/5ML

Approval Date

2020-03-30

211647 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

211647

Product Number

2

Dosage Form

-

Strength

10MG/5ML

Approval Date

2020-03-30

Regulatory Status

RX

2019
04 Oct
RX Application: 211779

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-10-04

211779 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

211779

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-10-04

Regulatory Status

RX

2019
04 Oct
RX Application: 211779

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-10-04

211779 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

211779

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-10-04

Regulatory Status

RX

2019
04 Oct
RX Application: 211779

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2019-10-04

211779 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

211779

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2019-10-04

Regulatory Status

RX

2020
06 Oct
RX Application: 212288

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2020-10-06

212288 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

212288

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2020-10-06

Regulatory Status

RX

2023
23 May
RX Application: 214447

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

18MG

Approval Date

2023-05-23

214447 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

214447

Product Number

1

Dosage Form

-

Strength

18MG

Approval Date

2023-05-23

Regulatory Status

RX

2023
23 May
RX Application: 214447

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

27MG

Approval Date

2023-05-23

214447 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

214447

Product Number

2

Dosage Form

-

Strength

27MG

Approval Date

2023-05-23

Regulatory Status

RX

2023
23 May
RX Application: 214447

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

36MG

Approval Date

2023-05-23

214447 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

214447

Product Number

3

Dosage Form

-

Strength

36MG

Approval Date

2023-05-23

Regulatory Status

RX

2023
23 May
RX Application: 214447

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

54MG

Approval Date

2023-05-23

214447 / 4

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

214447

Product Number

4

Dosage Form

-

Strength

54MG

Approval Date

2023-05-23

Regulatory Status

RX

2020
25 Nov
RX Application: 211143

Drug Name

METOPROLOL SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG TARTRATE

Approval Date

2020-11-25

211143 / 1

Active Ingredient

METOPROLOL SUCCINATE

Application Number

211143

Product Number

1

Dosage Form

-

Strength

EQ 25MG TARTRATE

Approval Date

2020-11-25

Regulatory Status

RX

2020
25 Nov
RX Application: 211143

Drug Name

METOPROLOL SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG TARTRATE

Approval Date

2020-11-25

211143 / 2

Active Ingredient

METOPROLOL SUCCINATE

Application Number

211143

Product Number

2

Dosage Form

-

Strength

EQ 50MG TARTRATE

Approval Date

2020-11-25

Regulatory Status

RX

2020
25 Nov
RX Application: 211143

Drug Name

METOPROLOL SUCCINATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

2020-11-25

211143 / 3

Active Ingredient

METOPROLOL SUCCINATE

Application Number

211143

Product Number

3

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

2020-11-25

Regulatory Status

RX

2020
25 Nov
RX Application: 211143

Drug Name

METOPROLOL SUCCINATE

Product Number

4

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

2020-11-25

211143 / 4

Active Ingredient

METOPROLOL SUCCINATE

Application Number

211143

Product Number

4

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

2020-11-25

Regulatory Status

RX

2016
28 Sep
RX Application: 204453

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2016-09-28

204453 / 1

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

204453

Product Number

1

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2016-09-28

Regulatory Status

RX

2016
28 Sep
RX Application: 204453

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2016-09-28

204453 / 2

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

204453

Product Number

2

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2016-09-28

Regulatory Status

RX

2016
28 Sep
RX Application: 204453

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 90MG BASE

Approval Date

2016-09-28

204453 / 3

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

204453

Product Number

3

Dosage Form

-

Strength

EQ 90MG BASE

Approval Date

2016-09-28

Regulatory Status

RX

2016
28 Sep
RX Application: 204453

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 105MG BASE

Approval Date

2016-09-28

204453 / 4

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

204453

Product Number

4

Dosage Form

-

Strength

EQ 105MG BASE

Approval Date

2016-09-28

Regulatory Status

RX

2016
28 Sep
RX Application: 204453

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 135MG BASE

Approval Date

2016-09-28

204453 / 5

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

204453

Product Number

5

Dosage Form

-

Strength

EQ 135MG BASE

Approval Date

2016-09-28

Regulatory Status

RX

2018
16 Mar
RX Application: 204453

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

EQ 65MG BASE

Approval Date

2018-03-16

204453 / 6

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

204453

Product Number

6

Dosage Form

-

Strength

EQ 65MG BASE

Approval Date

2018-03-16

Regulatory Status

RX

2018
16 Mar
RX Application: 204453

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

7

Dosage Form

-

Strength

EQ 115MG BASE

Approval Date

2018-03-16

204453 / 7

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

204453

Product Number

7

Dosage Form

-

Strength

EQ 115MG BASE

Approval Date

2018-03-16

Regulatory Status

RX

2019
19 Dec
RX Application: 204453

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

8

Dosage Form

-

Strength

EQ 55MG BASE

Approval Date

2019-12-19

204453 / 8

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

204453

Product Number

8

Dosage Form

-

Strength

EQ 55MG BASE

Approval Date

2019-12-19

Regulatory Status

RX

2024
12 Feb
RX Application: 215948

Drug Name

MIRABEGRON

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2024-02-12

215948 / 1

Active Ingredient

MIRABEGRON

Application Number

215948

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2024-02-12

Regulatory Status

RX

2024
12 Feb
RX Application: 215948

Drug Name

MIRABEGRON

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2024-02-12

215948 / 2

Active Ingredient

MIRABEGRON

Application Number

215948

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2024-02-12

Regulatory Status

RX

2026
20 Jan
RX Application: 219323

Drug Name

MIRABEGRON

Product Number

1

Dosage Form

-

Strength

8MG/ML

Approval Date

2026-01-20

219323 / 1

Active Ingredient

MIRABEGRON

Application Number

219323

Product Number

1

Dosage Form

-

Strength

8MG/ML

Approval Date

2026-01-20

Regulatory Status

RX

2020
03 Dec
RX Application: 212451

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2020-12-03

212451 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

212451

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2020-12-03

Regulatory Status

RX

2020
03 Dec
RX Application: 212451

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2020-12-03

212451 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

212451

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2020-12-03

Regulatory Status

RX

2011
04 Nov
RX Application: 91249

Drug Name

MYCOPHENOLATE MOFETIL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2011-11-04

91249 / 1

Active Ingredient

MYCOPHENOLATE MOFETIL

Application Number

91249

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2011-11-04

Regulatory Status

RX

2013
13 Jun
RX Application: 200197

Drug Name

MYCOPHENOLATE MOFETIL

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2013-06-13

200197 / 1

Active Ingredient

MYCOPHENOLATE MOFETIL

Application Number

200197

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2013-06-13

Regulatory Status

RX

2014
14 Nov
RX Application: 203005

Drug Name

MYCOPHENOLATE MOFETIL

Product Number

1

Dosage Form

-

Strength

200MG/ML

Approval Date

2014-11-14

203005 / 1

Active Ingredient

MYCOPHENOLATE MOFETIL

Application Number

203005

Product Number

1

Dosage Form

-

Strength

200MG/ML

Approval Date

2014-11-14

Regulatory Status

RX

2021
23 Sep
RX Application: 208315

Drug Name

MYCOPHENOLATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 180MG BASE

Approval Date

2021-09-23

208315 / 1

Active Ingredient

MYCOPHENOLATE SODIUM

Application Number

208315

Product Number

1

Dosage Form

-

Strength

EQ 180MG BASE

Approval Date

2021-09-23

Regulatory Status

RX

2021
23 Sep
RX Application: 208315

Drug Name

MYCOPHENOLATE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 360MG BASE

Approval Date

2021-09-23

208315 / 2

Active Ingredient

MYCOPHENOLATE SODIUM

Application Number

208315

Product Number

2

Dosage Form

-

Strength

EQ 360MG BASE

Approval Date

2021-09-23

Regulatory Status

RX

2022
29 Mar
RX Application: 216067

Drug Name

NIFEDIPINE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2022-03-29

216067 / 1

Active Ingredient

NIFEDIPINE

Application Number

216067

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2022-03-29

Regulatory Status

RX

2022
29 Mar
RX Application: 216067

Drug Name

NIFEDIPINE

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2022-03-29

216067 / 2

Active Ingredient

NIFEDIPINE

Application Number

216067

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2022-03-29

Regulatory Status

RX

2022
29 Mar
RX Application: 216067

Drug Name

NIFEDIPINE

Product Number

3

Dosage Form

-

Strength

90MG

Approval Date

2022-03-29

216067 / 3

Active Ingredient

NIFEDIPINE

Application Number

216067

Product Number

3

Dosage Form

-

Strength

90MG

Approval Date

2022-03-29

Regulatory Status

RX

2025
22 Jan
RX Application: 213409

Drug Name

NIMODIPINE

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2025-01-22

213409 / 1

Active Ingredient

NIMODIPINE

Application Number

213409

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2025-01-22

Regulatory Status

RX

2015
20 Oct
RX Application: 202295

Drug Name

OLANZAPINE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2015-10-20

202295 / 1

Active Ingredient

OLANZAPINE

Application Number

202295

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2015-10-20

Regulatory Status

RX

2015
20 Oct
RX Application: 202295

Drug Name

OLANZAPINE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2015-10-20

202295 / 2

Active Ingredient

OLANZAPINE

Application Number

202295

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2015-10-20

Regulatory Status

RX

2015
20 Oct
RX Application: 202295

Drug Name

OLANZAPINE

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2015-10-20

202295 / 3

Active Ingredient

OLANZAPINE

Application Number

202295

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2015-10-20

Regulatory Status

RX

2015
20 Oct
RX Application: 202295

Drug Name

OLANZAPINE

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2015-10-20

202295 / 4

Active Ingredient

OLANZAPINE

Application Number

202295

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2015-10-20

Regulatory Status

RX

2015
20 Oct
RX Application: 202295

Drug Name

OLANZAPINE

Product Number

5

Dosage Form

-

Strength

15MG

Approval Date

2015-10-20

202295 / 5

Active Ingredient

OLANZAPINE

Application Number

202295

Product Number

5

Dosage Form

-

Strength

15MG

Approval Date

2015-10-20

Regulatory Status

RX

2015
20 Oct
RX Application: 202295

Drug Name

OLANZAPINE

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2015-10-20

202295 / 6

Active Ingredient

OLANZAPINE

Application Number

202295

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2015-10-20

Regulatory Status

RX

2017
24 Apr
RX Application: 206763

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2017-04-24

206763 / 1

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

206763

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2017-04-24

Regulatory Status

RX

2017
24 Apr
RX Application: 206763

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2017-04-24

206763 / 2

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

206763

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2017-04-24

Regulatory Status

RX

2017
24 Apr
RX Application: 206763

Drug Name

OLMESARTAN MEDOXOMIL

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2017-04-24

206763 / 3

Active Ingredient

OLMESARTAN MEDOXOMIL

Application Number

206763

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2017-04-24

Regulatory Status

RX

2024
11 Jul
RX Application: 207037

Drug Name

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2024-07-11

207037 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

207037

Product Number

1

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2024-07-11

Regulatory Status

RX

2024
11 Jul
RX Application: 207037

Drug Name

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;40MG

Approval Date

2024-07-11

207037 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

207037

Product Number

2

Dosage Form

-

Strength

12.5MG;40MG

Approval Date

2024-07-11

Regulatory Status

RX

2024
11 Jul
RX Application: 207037

Drug Name

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;40MG

Approval Date

2024-07-11

207037 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

207037

Product Number

3

Dosage Form

-

Strength

25MG;40MG

Approval Date

2024-07-11

Regulatory Status

RX

2023
18 Mar
RX Application: 213183

Drug Name

OXCARBAZEPINE

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2023-03-18

213183 / 1

Active Ingredient

OXCARBAZEPINE

Application Number

213183

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2023-03-18

Regulatory Status

RX

2019
07 Feb
RX Application: 211748

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2019-02-07

211748 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

211748

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2019-02-07

Regulatory Status

RX

2019
04 Feb
RX Application: 211749

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2019-02-04

211749 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

211749

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2019-02-04

Regulatory Status

RX

2019
19 Jul
RX Application: 207623

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2019-07-19

207623 / 1

Active Ingredient

PREGABALIN

Application Number

207623

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 207799

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2019-07-19

207799 / 1

Active Ingredient

PREGABALIN

Application Number

207799

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 207799

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2019-07-19

207799 / 2

Active Ingredient

PREGABALIN

Application Number

207799

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 207799

Drug Name

PREGABALIN

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2019-07-19

207799 / 3

Active Ingredient

PREGABALIN

Application Number

207799

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 207799

Drug Name

PREGABALIN

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2019-07-19

207799 / 4

Active Ingredient

PREGABALIN

Application Number

207799

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 207799

Drug Name

PREGABALIN

Product Number

5

Dosage Form

-

Strength

225MG

Approval Date

2019-07-19

207799 / 5

Active Ingredient

PREGABALIN

Application Number

207799

Product Number

5

Dosage Form

-

Strength

225MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 207799

Drug Name

PREGABALIN

Product Number

6

Dosage Form

-

Strength

300MG

Approval Date

2019-07-19

207799 / 6

Active Ingredient

PREGABALIN

Application Number

207799

Product Number

6

Dosage Form

-

Strength

300MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
30 Sep
RX Application: 207799

Drug Name

PREGABALIN

Product Number

7

Dosage Form

-

Strength

25MG

Approval Date

2019-09-30

207799 / 7

Active Ingredient

PREGABALIN

Application Number

207799

Product Number

7

Dosage Form

-

Strength

25MG

Approval Date

2019-09-30

Regulatory Status

RX

2019
30 Sep
RX Application: 207799

Drug Name

PREGABALIN

Product Number

8

Dosage Form

-

Strength

50MG

Approval Date

2019-09-30

207799 / 8

Active Ingredient

PREGABALIN

Application Number

207799

Product Number

8

Dosage Form

-

Strength

50MG

Approval Date

2019-09-30

Regulatory Status

RX

2025
24 Jun
RX Application: 218295

Drug Name

PRUCALOPRIDE SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2025-06-24

218295 / 1

Active Ingredient

PRUCALOPRIDE SUCCINATE

Application Number

218295

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2025-06-24

Regulatory Status

RX

2025
24 Jun
RX Application: 218295

Drug Name

PRUCALOPRIDE SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2025-06-24

218295 / 2

Active Ingredient

PRUCALOPRIDE SUCCINATE

Application Number

218295

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2025-06-24

Regulatory Status

RX

2013
12 Feb
RX Application: 201504

Drug Name

QUETIAPINE FUMARATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2013-02-12

201504 / 1

Active Ingredient

QUETIAPINE FUMARATE

Application Number

201504

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2013-02-12

Regulatory Status

RX

2013
12 Feb
RX Application: 201504

Drug Name

QUETIAPINE FUMARATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2013-02-12

201504 / 2

Active Ingredient

QUETIAPINE FUMARATE

Application Number

201504

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2013-02-12

Regulatory Status

RX

2013
12 Feb
RX Application: 201504

Drug Name

QUETIAPINE FUMARATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2013-02-12

201504 / 3

Active Ingredient

QUETIAPINE FUMARATE

Application Number

201504

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2013-02-12

Regulatory Status

RX

2013
12 Feb
RX Application: 201504

Drug Name

QUETIAPINE FUMARATE

Product Number

4

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2013-02-12

201504 / 4

Active Ingredient

QUETIAPINE FUMARATE

Application Number

201504

Product Number

4

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2013-02-12

Regulatory Status

RX

2013
12 Feb
RX Application: 201504

Drug Name

QUETIAPINE FUMARATE

Product Number

5

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2013-02-12

201504 / 5

Active Ingredient

QUETIAPINE FUMARATE

Application Number

201504

Product Number

5

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2013-02-12

Regulatory Status

RX

2013
12 Feb
RX Application: 201504

Drug Name

QUETIAPINE FUMARATE

Product Number

6

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2013-02-12

201504 / 6

Active Ingredient

QUETIAPINE FUMARATE

Application Number

201504

Product Number

6

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2013-02-12

Regulatory Status

RX

2013
12 Feb
RX Application: 201504

Drug Name

QUETIAPINE FUMARATE

Product Number

7

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2013-02-12

201504 / 7

Active Ingredient

QUETIAPINE FUMARATE

Application Number

201504

Product Number

7

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2013-02-12

Regulatory Status

RX

2018
24 Apr
RX Application: 208644

Drug Name

RABEPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2018-04-24

208644 / 1

Active Ingredient

RABEPRAZOLE SODIUM

Application Number

208644

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2018-04-24

Regulatory Status

RX

2020
30 Nov
RX Application: 209953

Drug Name

RANOLAZINE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2020-11-30

209953 / 1

Active Ingredient

RANOLAZINE

Application Number

209953

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2020-11-30

Regulatory Status

RX

2020
30 Nov
RX Application: 209953

Drug Name

RANOLAZINE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2020-11-30

209953 / 2

Active Ingredient

RANOLAZINE

Application Number

209953

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2020-11-30

Regulatory Status

RX

2017
30 Oct
RX Application: 201889

Drug Name

RASAGILINE MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2017-10-30

201889 / 1

Active Ingredient

RASAGILINE MESYLATE

Application Number

201889

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2017-10-30

Regulatory Status

RX

2017
30 Oct
RX Application: 201889

Drug Name

RASAGILINE MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2017-10-30

201889 / 2

Active Ingredient

RASAGILINE MESYLATE

Application Number

201889

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2017-10-30

Regulatory Status

RX

2016
30 Mar
RX Application: 204048

Drug Name

RILUZOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2016-03-30

204048 / 1

Active Ingredient

RILUZOLE

Application Number

204048

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2016-03-30

Regulatory Status

RX

2024
22 Aug
RX Application: 216035

Drug Name

RILUZOLE

Product Number

1

Dosage Form

-

Strength

50MG/10ML

Approval Date

2024-08-22

216035 / 1

Active Ingredient

RILUZOLE

Application Number

216035

Product Number

1

Dosage Form

-

Strength

50MG/10ML

Approval Date

2024-08-22

Regulatory Status

RX

2025
26 Jun
RX Application: 218502

Drug Name

RIVAROXABAN

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2025-06-26

218502 / 1

Active Ingredient

RIVAROXABAN

Application Number

218502

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2025-06-26

Regulatory Status

RX

2016
18 Feb
RX Application: 203269

Drug Name

RIZATRIPTAN BENZOATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2016-02-18

203269 / 1

Active Ingredient

RIZATRIPTAN BENZOATE

Application Number

203269

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2016-02-18

Regulatory Status

RX

2016
18 Feb
RX Application: 203269

Drug Name

RIZATRIPTAN BENZOATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-02-18

203269 / 2

Active Ingredient

RIZATRIPTAN BENZOATE

Application Number

203269

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-02-18

Regulatory Status

RX

2023
18 Apr
RX Application: 212490

Drug Name

ROFLUMILAST

Product Number

1

Dosage Form

-

Strength

250MCG

Approval Date

2023-04-18

212490 / 1

Active Ingredient

ROFLUMILAST

Application Number

212490

Product Number

1

Dosage Form

-

Strength

250MCG

Approval Date

2023-04-18

Regulatory Status

RX

2023
18 Apr
RX Application: 212490

Drug Name

ROFLUMILAST

Product Number

2

Dosage Form

-

Strength

500MCG

Approval Date

2023-04-18

212490 / 2

Active Ingredient

ROFLUMILAST

Application Number

212490

Product Number

2

Dosage Form

-

Strength

500MCG

Approval Date

2023-04-18

Regulatory Status

RX

2017
21 Mar
RX Application: 206465

Drug Name

ROSUVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2017-03-21

206465 / 1

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

206465

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2017-03-21

Regulatory Status

RX

2017
21 Mar
RX Application: 206465

Drug Name

ROSUVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2017-03-21

206465 / 2

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

206465

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2017-03-21

Regulatory Status

RX

2017
21 Mar
RX Application: 206465

Drug Name

ROSUVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2017-03-21

206465 / 3

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

206465

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2017-03-21

Regulatory Status

RX

2017
21 Mar
RX Application: 206465

Drug Name

ROSUVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2017-03-21

206465 / 4

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

206465

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2017-03-21

Regulatory Status

RX

2021
23 Feb
RX Application: 213410

Drug Name

RUFINAMIDE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2021-02-23

213410 / 1

Active Ingredient

RUFINAMIDE

Application Number

213410

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2021-02-23

Regulatory Status

RX

2024
16 Sep
RX Application: 213764

Drug Name

SACUBITRIL AND VALSARTAN

Product Number

1

Dosage Form

-

Strength

24MG;26MG

Approval Date

2024-09-16

213764 / 1

Active Ingredient

SACUBITRIL; VALSARTAN

Application Number

213764

Product Number

1

Dosage Form

-

Strength

24MG;26MG

Approval Date

2024-09-16

Regulatory Status

RX

2024
16 Sep
RX Application: 213764

Drug Name

SACUBITRIL AND VALSARTAN

Product Number

2

Dosage Form

-

Strength

49MG;51MG

Approval Date

2024-09-16

213764 / 2

Active Ingredient

SACUBITRIL; VALSARTAN

Application Number

213764

Product Number

2

Dosage Form

-

Strength

49MG;51MG

Approval Date

2024-09-16

Regulatory Status

RX

2024
16 Sep
RX Application: 213764

Drug Name

SACUBITRIL AND VALSARTAN

Product Number

3

Dosage Form

-

Strength

97MG;103MG

Approval Date

2024-09-16

213764 / 3

Active Ingredient

SACUBITRIL; VALSARTAN

Application Number

213764

Product Number

3

Dosage Form

-

Strength

97MG;103MG

Approval Date

2024-09-16

Regulatory Status

RX

2019
27 Nov
RX Application: 212440

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2019-11-27

212440 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

212440

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2019-11-27

Regulatory Status

RX

2021
12 Mar
RX Application: 214753

Drug Name

SIROLIMUS

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2021-03-12

214753 / 1

Active Ingredient

SIROLIMUS

Application Number

214753

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2021-03-12

Regulatory Status

RX

2021
12 Mar
RX Application: 214753

Drug Name

SIROLIMUS

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2021-03-12

214753 / 2

Active Ingredient

SIROLIMUS

Application Number

214753

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2021-03-12

Regulatory Status

RX

2021
12 Mar
RX Application: 214753

Drug Name

SIROLIMUS

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2021-03-12

214753 / 3

Active Ingredient

SIROLIMUS

Application Number

214753

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2021-03-12

Regulatory Status

RX

2023
29 Dec
RX Application: 213924

Drug Name

SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2023-12-29

213924 / 1

Active Ingredient

MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

Application Number

213924

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2023-12-29

Regulatory Status

RX

2019
20 May
RX Application: 210224

Drug Name

SOLIFENACIN SUCCINATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-05-20

210224 / 1

Active Ingredient

SOLIFENACIN SUCCINATE

Application Number

210224

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-05-20

Regulatory Status

RX

2019
20 May
RX Application: 210224

Drug Name

SOLIFENACIN SUCCINATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-05-20

210224 / 2

Active Ingredient

SOLIFENACIN SUCCINATE

Application Number

210224

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-05-20

Regulatory Status

RX

2026
17 Jun
RX Application: 218722

Drug Name

SOLRIAMFETOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2026-06-17

218722 / 1

Active Ingredient

SOLRIAMFETOL HYDROCHLORIDE

Application Number

218722

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2026-06-17

Regulatory Status

RX

2026
17 Jun
RX Application: 218722

Drug Name

SOLRIAMFETOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2026-06-17

218722 / 2

Active Ingredient

SOLRIAMFETOL HYDROCHLORIDE

Application Number

218722

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2026-06-17

Regulatory Status

RX

2020
12 Nov
RX Application: 203740

Drug Name

TACROLIMUS

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2020-11-12

203740 / 1

Active Ingredient

TACROLIMUS

Application Number

203740

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2020-11-12

Regulatory Status

RX

2020
12 Nov
RX Application: 203740

Drug Name

TACROLIMUS

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2020-11-12

203740 / 2

Active Ingredient

TACROLIMUS

Application Number

203740

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2020-11-12

Regulatory Status

RX

2020
12 Nov
RX Application: 203740

Drug Name

TACROLIMUS

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2020-11-12

203740 / 3

Active Ingredient

TACROLIMUS

Application Number

203740

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2020-11-12

Regulatory Status

RX

2017
11 Aug
RX Application: 207405

Drug Name

TAMSULOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.4MG

Approval Date

2017-08-11

207405 / 1

Active Ingredient

TAMSULOSIN HYDROCHLORIDE

Application Number

207405

Product Number

1

Dosage Form

-

Strength

0.4MG

Approval Date

2017-08-11

Regulatory Status

RX

2023
24 Aug
RX Application: 217875

Drug Name

TEMAZEPAM

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2023-08-24

217875 / 1

Active Ingredient

TEMAZEPAM

Application Number

217875

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2023-08-24

Regulatory Status

RX

2023
24 Aug
RX Application: 217875

Drug Name

TEMAZEPAM

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2023-08-24

217875 / 2

Active Ingredient

TEMAZEPAM

Application Number

217875

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2023-08-24

Regulatory Status

RX

2023
24 Aug
RX Application: 217875

Drug Name

TEMAZEPAM

Product Number

3

Dosage Form

-

Strength

22.5MG

Approval Date

2023-08-24

217875 / 3

Active Ingredient

TEMAZEPAM

Application Number

217875

Product Number

3

Dosage Form

-

Strength

22.5MG

Approval Date

2023-08-24

Regulatory Status

RX

2023
24 Aug
RX Application: 217875

Drug Name

TEMAZEPAM

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2023-08-24

217875 / 4

Active Ingredient

TEMAZEPAM

Application Number

217875

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2023-08-24

Regulatory Status

RX

2023
21 Apr
RX Application: 208567

Drug Name

TICAGRELOR

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2023-04-21

208567 / 1

Active Ingredient

TICAGRELOR

Application Number

208567

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2023-04-21

Regulatory Status

RX

2025
28 Oct
RX Application: 210219

Drug Name

TICAGRELOR

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2025-10-28

210219 / 1

Active Ingredient

TICAGRELOR

Application Number

210219

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2025-10-28

Regulatory Status

RX

2019
25 Jan
RX Application: 211798

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2019-01-25

211798 / 1

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

211798

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2019-01-25

Regulatory Status

RX

2019
25 Jan
RX Application: 211798

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2019-01-25

211798 / 2

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

211798

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2019-01-25

Regulatory Status

RX

2019
27 Mar
RX Application: 212196

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2019-03-27

212196 / 1

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

212196

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2019-03-27

Regulatory Status

RX

2019
27 Mar
RX Application: 212196

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2019-03-27

212196 / 2

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

212196

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2019-03-27

Regulatory Status

RX

2019
27 Mar
RX Application: 212196

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2019-03-27

212196 / 3

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

212196

Product Number

3

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2019-03-27

Regulatory Status

RX

2021
01 Apr
RX Application: 212848

Drug Name

TOBRAMYCIN

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2021-04-01

212848 / 1

Active Ingredient

TOBRAMYCIN

Application Number

212848

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2021-04-01

Regulatory Status

RX

2020
19 May
RX Application: 211891

Drug Name

TOLVAPTAN

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2020-05-19

211891 / 1

Active Ingredient

TOLVAPTAN

Application Number

211891

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2020-05-19

Regulatory Status

RX

2020
19 May
RX Application: 211891

Drug Name

TOLVAPTAN

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2020-05-19

211891 / 2

Active Ingredient

TOLVAPTAN

Application Number

211891

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2020-05-19

Regulatory Status

RX

2022
06 Sep
RX Application: 211891

Drug Name

TOLVAPTAN

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2022-09-06

211891 / 3

Active Ingredient

TOLVAPTAN

Application Number

211891

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2022-09-06

Regulatory Status

RX

2026
21 Apr
RX Application: 220147

Drug Name

TOLVAPTAN

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2026-04-21

220147 / 1

Active Ingredient

TOLVAPTAN

Application Number

220147

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2026-04-21

Regulatory Status

RX

2026
21 Apr
RX Application: 220147

Drug Name

TOLVAPTAN

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2026-04-21

220147 / 2

Active Ingredient

TOLVAPTAN

Application Number

220147

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2026-04-21

Regulatory Status

RX

2026
21 Apr
RX Application: 220147

Drug Name

TOLVAPTAN

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2026-04-21

220147 / 3

Active Ingredient

TOLVAPTAN

Application Number

220147

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2026-04-21

Regulatory Status

RX

2026
21 Apr
RX Application: 220147

Drug Name

TOLVAPTAN

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

2026-04-21

220147 / 4

Active Ingredient

TOLVAPTAN

Application Number

220147

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

2026-04-21

Regulatory Status

RX

2026
21 Apr
RX Application: 220147

Drug Name

TOLVAPTAN

Product Number

5

Dosage Form

-

Strength

90MG

Approval Date

2026-04-21

220147 / 5

Active Ingredient

TOLVAPTAN

Application Number

220147

Product Number

5

Dosage Form

-

Strength

90MG

Approval Date

2026-04-21

Regulatory Status

RX

2023
20 Jun
RX Application: 217248

Drug Name

TOPIRAMATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2023-06-20

217248 / 1

Active Ingredient

TOPIRAMATE

Application Number

217248

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2023-06-20

Regulatory Status

RX

2023
20 Jun
RX Application: 217248

Drug Name

TOPIRAMATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2023-06-20

217248 / 2

Active Ingredient

TOPIRAMATE

Application Number

217248

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2023-06-20

Regulatory Status

RX

2023
20 Jun
RX Application: 217248

Drug Name

TOPIRAMATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2023-06-20

217248 / 3

Active Ingredient

TOPIRAMATE

Application Number

217248

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2023-06-20

Regulatory Status

RX

2023
20 Jun
RX Application: 217248

Drug Name

TOPIRAMATE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2023-06-20

217248 / 4

Active Ingredient

TOPIRAMATE

Application Number

217248

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2023-06-20

Regulatory Status

RX

2024
31 Oct
RX Application: 217795

Drug Name

TOPIRAMATE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2024-10-31

217795 / 1

Active Ingredient

TOPIRAMATE

Application Number

217795

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2024-10-31

Regulatory Status

RX

2024
13 Jun
RX Application: 218482

Drug Name

TOPIRAMATE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2024-06-13

218482 / 1

Active Ingredient

TOPIRAMATE

Application Number

218482

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2024-06-13

Regulatory Status

RX

2024
13 Jun
RX Application: 218482

Drug Name

TOPIRAMATE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2024-06-13

218482 / 2

Active Ingredient

TOPIRAMATE

Application Number

218482

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2024-06-13

Regulatory Status

RX

2012
30 Mar
RX Application: 202076

Drug Name

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;37.5MG

Approval Date

2012-03-30

202076 / 1

Active Ingredient

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Application Number

202076

Product Number

1

Dosage Form

-

Strength

325MG;37.5MG

Approval Date

2012-03-30

Regulatory Status

RX

2017
26 Dec
RX Application: 207651

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

2017-12-26

207651 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

207651

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

2017-12-26

Regulatory Status

RX

2017
26 Dec
RX Application: 207651

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

2017-12-26

207651 / 2

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

207651

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

2017-12-26

Regulatory Status

RX

2017
26 Dec
RX Application: 207651

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

3

Dosage Form

-

Strength

0.5%

Approval Date

2017-12-26

207651 / 3

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

207651

Product Number

3

Dosage Form

-

Strength

0.5%

Approval Date

2017-12-26

Regulatory Status

RX

2019
12 Mar
RX Application: 205536

Drug Name

VALSARTAN

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2019-03-12

205536 / 1

Active Ingredient

VALSARTAN

Application Number

205536

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2019-03-12

Regulatory Status

RX

2019
12 Mar
RX Application: 205536

Drug Name

VALSARTAN

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2019-03-12

205536 / 2

Active Ingredient

VALSARTAN

Application Number

205536

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2019-03-12

Regulatory Status

RX

2019
12 Mar
RX Application: 205536

Drug Name

VALSARTAN

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2019-03-12

205536 / 3

Active Ingredient

VALSARTAN

Application Number

205536

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2019-03-12

Regulatory Status

RX

2019
12 Mar
RX Application: 205536

Drug Name

VALSARTAN

Product Number

4

Dosage Form

-

Strength

320MG

Approval Date

2019-03-12

205536 / 4

Active Ingredient

VALSARTAN

Application Number

205536

Product Number

4

Dosage Form

-

Strength

320MG

Approval Date

2019-03-12

Regulatory Status

RX

2022
14 Nov
RX Application: 214913

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/ML

Approval Date

2022-11-14

214913 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

214913

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/ML

Approval Date

2022-11-14

Regulatory Status

RX

2022
14 Nov
RX Application: 214913

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

2022-11-14

214913 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

214913

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

2022-11-14

Regulatory Status

RX

2023
23 Aug
RX Application: 214557

Drug Name

VARENICLINE TARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2023-08-23

214557 / 1

Active Ingredient

VARENICLINE TARTRATE

Application Number

214557

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2023-08-23

Regulatory Status

RX

2023
23 Aug
RX Application: 214557

Drug Name

VARENICLINE TARTRATE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2023-08-23

214557 / 2

Active Ingredient

VARENICLINE TARTRATE

Application Number

214557

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2023-08-23

Regulatory Status

RX

2021
10 Jun
RX Application: 214127

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2021-06-10

214127 / 1

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

214127

Product Number

1

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2021-06-10

Regulatory Status

RX

2021
10 Jun
RX Application: 214127

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2021-06-10

214127 / 2

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

214127

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2021-06-10

Regulatory Status

RX

2021
10 Jun
RX Application: 214127

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2021-06-10

214127 / 3

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

214127

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2021-06-10

Regulatory Status

RX

2021
10 Jun
RX Application: 214127

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 225MG BASE

Approval Date

2021-06-10

214127 / 4

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

214127

Product Number

4

Dosage Form

-

Strength

EQ 225MG BASE

Approval Date

2021-06-10

Regulatory Status

RX

2020
02 Dec
RX Application: 213375

Drug Name

VIGABATRIN

Product Number

1

Dosage Form

-

Strength

500MG/PACKET

Approval Date

2020-12-02

213375 / 1

Active Ingredient

VIGABATRIN

Application Number

213375

Product Number

1

Dosage Form

-

Strength

500MG/PACKET

Approval Date

2020-12-02

Regulatory Status

RX

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Drug Status Breakdown
345 total
  • RX
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

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Application Number

209042

Product Number

1

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Dosage Form

-

Strength

EQ 5MG BASE;20MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

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Organized FDA drug records

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