Cipla RX
FDA Approved Drugs

Cipla 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 140
  • Latest Approval Date Jul 27, 2026
  • Data Source FDA
  • First Approval Date Apr 18, 2005
All
274
View
Unclassified
66
View
Discontinued
67
View
OTC
1
View
RX
140
View
Company Overview

Company

Cipla RX

Country

India

Website

Visit Website

Email

corporate.one@cipla.com

Social Profiles

Company Snapshot

Cipla RX

Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra 400 013

India

www.cipla.com/ corporate.one@cipla.com View on Map
FDA Approved Drug Records ( 140 records )
2017
21 Nov
RX Application: 78119

Drug Name

ABACAVIR SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2017-11-21

78119 / 1

Active Ingredient

ABACAVIR SULFATE

Application Number

78119

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2017-11-21

Regulatory Status

RX

2017
28 Mar
RX Application: 91144

Drug Name

ABACAVIR SULFATE AND LAMIVUDINE

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE;300MG

Approval Date

2017-03-28

91144 / 1

Active Ingredient

ABACAVIR SULFATE; LAMIVUDINE

Application Number

91144

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE;300MG

Approval Date

2017-03-28

Regulatory Status

RX

2020
08 Apr
RX Application: 209959

Drug Name

ALBUTEROL SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 0.09MG BASE/INH

Approval Date

2020-04-08

209959 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

209959

Product Number

1

Dosage Form

-

Strength

EQ 0.09MG BASE/INH

Approval Date

2020-04-08

Regulatory Status

RX

2026
22 Apr
RX Application: 219409

Drug Name

ALBUTEROL SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 0.09MG BASE/INH

Approval Date

2026-04-22

219409 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

219409

Product Number

1

Dosage Form

-

Strength

EQ 0.09MG BASE/INH

Approval Date

2026-04-22

Regulatory Status

RX

2007
31 Dec
RX Application: 77559

Drug Name

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.083% BASE;0.017%

Approval Date

2007-12-31

77559 / 1

Active Ingredient

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Application Number

77559

Product Number

1

Dosage Form

-

Strength

EQ 0.083% BASE;0.017%

Approval Date

2007-12-31

Regulatory Status

RX

2008
04 Aug
RX Application: 76768

Drug Name

ALENDRONATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2008-08-04

76768 / 1

Active Ingredient

ALENDRONATE SODIUM

Application Number

76768

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2008-08-04

Regulatory Status

RX

2008
04 Aug
RX Application: 76768

Drug Name

ALENDRONATE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2008-08-04

76768 / 2

Active Ingredient

ALENDRONATE SODIUM

Application Number

76768

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2008-08-04

Regulatory Status

RX

2008
04 Aug
RX Application: 76768

Drug Name

ALENDRONATE SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 35MG BASE

Approval Date

2008-08-04

76768 / 3

Active Ingredient

ALENDRONATE SODIUM

Application Number

76768

Product Number

3

Dosage Form

-

Strength

EQ 35MG BASE

Approval Date

2008-08-04

Regulatory Status

RX

2008
04 Aug
RX Application: 76768

Drug Name

ALENDRONATE SODIUM

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2008-08-04

76768 / 4

Active Ingredient

ALENDRONATE SODIUM

Application Number

76768

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2008-08-04

Regulatory Status

RX

2008
04 Aug
RX Application: 76768

Drug Name

ALENDRONATE SODIUM

Product Number

5

Dosage Form

-

Strength

EQ 70MG BASE

Approval Date

2008-08-04

76768 / 5

Active Ingredient

ALENDRONATE SODIUM

Application Number

76768

Product Number

5

Dosage Form

-

Strength

EQ 70MG BASE

Approval Date

2008-08-04

Regulatory Status

RX

2019
26 Apr
RX Application: 210715

Drug Name

AMBRISENTAN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-04-26

210715 / 1

Active Ingredient

AMBRISENTAN

Application Number

210715

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-04-26

Regulatory Status

RX

2019
26 Apr
RX Application: 210715

Drug Name

AMBRISENTAN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-04-26

210715 / 2

Active Ingredient

AMBRISENTAN

Application Number

210715

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-04-26

Regulatory Status

RX

2007
26 Sep
RX Application: 77073

Drug Name

AMLODIPINE BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-09-26

77073 / 1

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77073

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-09-26

Regulatory Status

RX

2007
26 Sep
RX Application: 77073

Drug Name

AMLODIPINE BESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-09-26

77073 / 2

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77073

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-09-26

Regulatory Status

RX

2007
26 Sep
RX Application: 77073

Drug Name

AMLODIPINE BESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-09-26

77073 / 3

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77073

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-09-26

Regulatory Status

RX

2013
02 Dec
RX Application: 65420

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2013-12-02

65420 / 1

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65420

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2013-12-02

Regulatory Status

RX

2008
25 Nov
RX Application: 65431

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

1

Dosage Form

-

Strength

250MG/5ML;EQ 62.5MG BASE/5ML

Approval Date

2008-11-25

65431 / 1

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65431

Product Number

1

Dosage Form

-

Strength

250MG/5ML;EQ 62.5MG BASE/5ML

Approval Date

2008-11-25

Regulatory Status

RX

2005
18 Apr
RX Application: 76468

Drug Name

ANAGRELIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2005-04-18

76468 / 1

Active Ingredient

ANAGRELIDE HYDROCHLORIDE

Application Number

76468

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2005-04-18

Regulatory Status

RX

2005
18 Apr
RX Application: 76468

Drug Name

ANAGRELIDE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2005-04-18

76468 / 2

Active Ingredient

ANAGRELIDE HYDROCHLORIDE

Application Number

76468

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2005-04-18

Regulatory Status

RX

2010
28 Jun
RX Application: 91164

Drug Name

ANASTROZOLE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2010-06-28

91164 / 1

Active Ingredient

ANASTROZOLE

Application Number

91164

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2010-06-28

Regulatory Status

RX

2021
22 Jun
RX Application: 207306

Drug Name

ARFORMOTEROL TARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 0.015MG BASE/2ML

Approval Date

2021-06-22

207306 / 1

Active Ingredient

ARFORMOTEROL TARTRATE

Application Number

207306

Product Number

1

Dosage Form

-

Strength

EQ 0.015MG BASE/2ML

Approval Date

2021-06-22

Regulatory Status

RX

2018
04 May
RX Application: 209540

Drug Name

AZACITIDINE

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2018-05-04

209540 / 1

Active Ingredient

AZACITIDINE

Application Number

209540

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2018-05-04

Regulatory Status

RX

2017
16 Nov
RX Application: 205710

Drug Name

BUDESONIDE

Product Number

1

Dosage Form

-

Strength

0.25MG/2ML

Approval Date

2017-11-16

205710 / 1

Active Ingredient

BUDESONIDE

Application Number

205710

Product Number

1

Dosage Form

-

Strength

0.25MG/2ML

Approval Date

2017-11-16

Regulatory Status

RX

2017
16 Nov
RX Application: 205710

Drug Name

BUDESONIDE

Product Number

2

Dosage Form

-

Strength

0.5MG/2ML

Approval Date

2017-11-16

205710 / 2

Active Ingredient

BUDESONIDE

Application Number

205710

Product Number

2

Dosage Form

-

Strength

0.5MG/2ML

Approval Date

2017-11-16

Regulatory Status

RX

2017
16 Nov
RX Application: 205710

Drug Name

BUDESONIDE

Product Number

3

Dosage Form

-

Strength

1MG/2ML

Approval Date

2017-11-16

205710 / 3

Active Ingredient

BUDESONIDE

Application Number

205710

Product Number

3

Dosage Form

-

Strength

1MG/2ML

Approval Date

2017-11-16

Regulatory Status

RX

2024
20 Sep
RX Application: 213766

Drug Name

CALCITONIN-SALMON

Product Number

1

Dosage Form

-

Strength

200 IU/ML

Approval Date

2024-09-20

213766 / 1

Active Ingredient

CALCITONIN SALMON

Application Number

213766

Product Number

1

Dosage Form

-

Strength

200 IU/ML

Approval Date

2024-09-20

Regulatory Status

RX

2015
23 Sep
RX Application: 207446

Drug Name

CELECOXIB

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2015-09-23

207446 / 1

Active Ingredient

CELECOXIB

Application Number

207446

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2015-09-23

Regulatory Status

RX

2015
23 Sep
RX Application: 207446

Drug Name

CELECOXIB

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2015-09-23

207446 / 2

Active Ingredient

CELECOXIB

Application Number

207446

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2015-09-23

Regulatory Status

RX

2015
23 Sep
RX Application: 207446

Drug Name

CELECOXIB

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2015-09-23

207446 / 3

Active Ingredient

CELECOXIB

Application Number

207446

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2015-09-23

Regulatory Status

RX

2015
23 Sep
RX Application: 207446

Drug Name

CELECOXIB

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

2015-09-23

207446 / 4

Active Ingredient

CELECOXIB

Application Number

207446

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

2015-09-23

Regulatory Status

RX

2018
08 Mar
RX Application: 208915

Drug Name

CINACALCET HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2018-03-08

208915 / 1

Active Ingredient

CINACALCET HYDROCHLORIDE

Application Number

208915

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2018-03-08

Regulatory Status

RX

2018
08 Mar
RX Application: 208915

Drug Name

CINACALCET HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2018-03-08

208915 / 2

Active Ingredient

CINACALCET HYDROCHLORIDE

Application Number

208915

Product Number

2

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2018-03-08

Regulatory Status

RX

2018
08 Mar
RX Application: 208915

Drug Name

CINACALCET HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 90MG BASE

Approval Date

2018-03-08

208915 / 3

Active Ingredient

CINACALCET HYDROCHLORIDE

Application Number

208915

Product Number

3

Dosage Form

-

Strength

EQ 90MG BASE

Approval Date

2018-03-08

Regulatory Status

RX

2019
18 Jan
RX Application: 211608

Drug Name

CYCLOPHOSPHAMIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-01-18

211608 / 1

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

211608

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-01-18

Regulatory Status

RX

2019
18 Jan
RX Application: 211608

Drug Name

CYCLOPHOSPHAMIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2019-01-18

211608 / 2

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

211608

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2019-01-18

Regulatory Status

RX

2026
06 Apr
RX Application: 211535

Drug Name

DAPAGLIFLOZIN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2026-04-06

211535 / 1

Active Ingredient

DAPAGLIFLOZIN

Application Number

211535

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211535

Drug Name

DAPAGLIFLOZIN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-04-06

211535 / 2

Active Ingredient

DAPAGLIFLOZIN

Application Number

211535

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211536

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG;500MG

Approval Date

2026-04-06

211536 / 1

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211536

Product Number

1

Dosage Form

-

Strength

5MG;500MG

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211536

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG;500MG

Approval Date

2026-04-06

211536 / 2

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211536

Product Number

2

Dosage Form

-

Strength

10MG;500MG

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211536

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG;1GM

Approval Date

2026-04-06

211536 / 3

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211536

Product Number

3

Dosage Form

-

Strength

10MG;1GM

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211595

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG;1GM

Approval Date

2026-04-06

211595 / 1

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211595

Product Number

1

Dosage Form

-

Strength

5MG;1GM

Approval Date

2026-04-06

Regulatory Status

RX

2016
01 Sep
RX Application: 207664

Drug Name

DARIFENACIN HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 7.5MG BASE

Approval Date

2016-09-01

207664 / 1

Active Ingredient

DARIFENACIN HYDROBROMIDE

Application Number

207664

Product Number

1

Dosage Form

-

Strength

EQ 7.5MG BASE

Approval Date

2016-09-01

Regulatory Status

RX

2016
01 Sep
RX Application: 207664

Drug Name

DARIFENACIN HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2016-09-01

207664 / 2

Active Ingredient

DARIFENACIN HYDROBROMIDE

Application Number

207664

Product Number

2

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2016-09-01

Regulatory Status

RX

2023
28 Nov
RX Application: 206288

Drug Name

DARUNAVIR

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2023-11-28

206288 / 1

Active Ingredient

DARUNAVIR

Application Number

206288

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2023-11-28

Regulatory Status

RX

2023
28 Nov
RX Application: 206288

Drug Name

DARUNAVIR

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2023-11-28

206288 / 2

Active Ingredient

DARUNAVIR

Application Number

206288

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2023-11-28

Regulatory Status

RX

2022
23 Feb
RX Application: 215026

Drug Name

DEFERASIROX

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2022-02-23

215026 / 1

Active Ingredient

DEFERASIROX

Application Number

215026

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2022-02-23

Regulatory Status

RX

2022
23 Feb
RX Application: 215026

Drug Name

DEFERASIROX

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2022-02-23

215026 / 2

Active Ingredient

DEFERASIROX

Application Number

215026

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2022-02-23

Regulatory Status

RX

2022
23 Feb
RX Application: 215026

Drug Name

DEFERASIROX

Product Number

3

Dosage Form

-

Strength

360MG

Approval Date

2022-02-23

215026 / 3

Active Ingredient

DEFERASIROX

Application Number

215026

Product Number

3

Dosage Form

-

Strength

360MG

Approval Date

2022-02-23

Regulatory Status

RX

2021
09 Aug
RX Application: 211776

Drug Name

DIFLUPREDNATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2021-08-09

211776 / 1

Active Ingredient

DIFLUPREDNATE

Application Number

211776

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2021-08-09

Regulatory Status

RX

2020
20 May
RX Application: 212907

Drug Name

DIHYDROERGOTAMINE MESYLATE

Product Number

1

Dosage Form

-

Strength

0.5MG/SPRAY

Approval Date

2020-05-20

212907 / 1

Active Ingredient

DIHYDROERGOTAMINE MESYLATE

Application Number

212907

Product Number

1

Dosage Form

-

Strength

0.5MG/SPRAY

Approval Date

2020-05-20

Regulatory Status

RX

2011
31 May
RX Application: 77518

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-05-31

77518 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

77518

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-05-31

Regulatory Status

RX

2011
31 May
RX Application: 77518

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-05-31

77518 / 2

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

77518

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-05-31

Regulatory Status

RX

2018
15 Jun
RX Application: 204766

Drug Name

EFAVIRENZ

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2018-06-15

204766 / 1

Active Ingredient

EFAVIRENZ

Application Number

204766

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2018-06-15

Regulatory Status

RX

2019
03 Jun
RX Application: 206894

Drug Name

EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE

Product Number

1

Dosage Form

-

Strength

600MG;200MG;300MG

Approval Date

2019-06-03

206894 / 1

Active Ingredient

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Application Number

206894

Product Number

1

Dosage Form

-

Strength

600MG;200MG;300MG

Approval Date

2019-06-03

Regulatory Status

RX

2018
02 Jul
RX Application: 91168

Drug Name

EMTRICITABINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2018-07-02

91168 / 1

Active Ingredient

EMTRICITABINE

Application Number

91168

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2018-07-02

Regulatory Status

RX

2016
06 Dec
RX Application: 206872

Drug Name

ENTECAVIR

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2016-12-06

206872 / 1

Active Ingredient

ENTECAVIR

Application Number

206872

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2016-12-06

Regulatory Status

RX

2016
06 Dec
RX Application: 206872

Drug Name

ENTECAVIR

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2016-12-06

206872 / 2

Active Ingredient

ENTECAVIR

Application Number

206872

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2016-12-06

Regulatory Status

RX

2007
22 Oct
RX Application: 65361

Drug Name

EPIRUBICIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/25ML (2MG/ML)

Approval Date

2007-10-22

65361 / 1

Active Ingredient

EPIRUBICIN HYDROCHLORIDE

Application Number

65361

Product Number

1

Dosage Form

-

Strength

50MG/25ML (2MG/ML)

Approval Date

2007-10-22

Regulatory Status

RX

2007
22 Oct
RX Application: 65361

Drug Name

EPIRUBICIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2007-10-22

65361 / 2

Active Ingredient

EPIRUBICIN HYDROCHLORIDE

Application Number

65361

Product Number

2

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2007-10-22

Regulatory Status

RX

2020
23 Mar
RX Application: 211751

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/PACKET

Approval Date

2020-03-23

211751 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

211751

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/PACKET

Approval Date

2020-03-23

Regulatory Status

RX

2020
23 Mar
RX Application: 211751

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/PACKET

Approval Date

2020-03-23

211751 / 2

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

211751

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/PACKET

Approval Date

2020-03-23

Regulatory Status

RX

2020
23 Mar
RX Application: 211752

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/PACKET

Approval Date

2020-03-23

211752 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

211752

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/PACKET

Approval Date

2020-03-23

Regulatory Status

RX

2025
07 Jan
RX Application: 217714

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE/PACKET

Approval Date

2025-01-07

217714 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

217714

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE/PACKET

Approval Date

2025-01-07

Regulatory Status

RX

2025
07 Jan
RX Application: 217714

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/PACKET

Approval Date

2025-01-07

217714 / 2

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

217714

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/PACKET

Approval Date

2025-01-07

Regulatory Status

RX

2018
27 Apr
RX Application: 210323

Drug Name

EXEMESTANE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2018-04-27

210323 / 1

Active Ingredient

EXEMESTANE

Application Number

210323

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2018-04-27

Regulatory Status

RX

2016
15 Dec
RX Application: 208709

Drug Name

FENOFIBRATE

Product Number

1

Dosage Form

-

Strength

48MG

Approval Date

2016-12-15

208709 / 1

Active Ingredient

FENOFIBRATE

Application Number

208709

Product Number

1

Dosage Form

-

Strength

48MG

Approval Date

2016-12-15

Regulatory Status

RX

2016
15 Dec
RX Application: 208709

Drug Name

FENOFIBRATE

Product Number

2

Dosage Form

-

Strength

145MG

Approval Date

2016-12-15

208709 / 2

Active Ingredient

FENOFIBRATE

Application Number

208709

Product Number

2

Dosage Form

-

Strength

145MG

Approval Date

2016-12-15

Regulatory Status

RX

2026
27 Jul
RX Application: 213087

Drug Name

FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE

Product Number

1

Dosage Form

-

Strength

0.1MG/INH;EQ 0.05MG BASE/INH

Approval Date

2026-07-27

213087 / 1

Active Ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Application Number

213087

Product Number

1

Dosage Form

-

Strength

0.1MG/INH;EQ 0.05MG BASE/INH

Approval Date

2026-07-27

Regulatory Status

RX

2026
27 Jul
RX Application: 213087

Drug Name

FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE

Product Number

2

Dosage Form

-

Strength

0.25MG/INH;EQ 0.05MG BASE/INH

Approval Date

2026-07-27

213087 / 2

Active Ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Application Number

213087

Product Number

2

Dosage Form

-

Strength

0.25MG/INH;EQ 0.05MG BASE/INH

Approval Date

2026-07-27

Regulatory Status

RX

2026
27 Jul
RX Application: 213087

Drug Name

FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE

Product Number

3

Dosage Form

-

Strength

0.5MG/INH;EQ 0.05MG BASE/INH

Approval Date

2026-07-27

213087 / 3

Active Ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Application Number

213087

Product Number

3

Dosage Form

-

Strength

0.5MG/INH;EQ 0.05MG BASE/INH

Approval Date

2026-07-27

Regulatory Status

RX

2022
26 Jan
RX Application: 211881

Drug Name

FOSFOMYCIN TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

EQ 3GM BASE/PACKET

Approval Date

2022-01-26

211881 / 1

Active Ingredient

FOSFOMYCIN TROMETHAMINE

Application Number

211881

Product Number

1

Dosage Form

-

Strength

EQ 3GM BASE/PACKET

Approval Date

2022-01-26

Regulatory Status

RX

2025
15 Sep
RX Application: 218813

Drug Name

GLUCAGON

Product Number

1

Dosage Form

-

Strength

1MG/VIAL

Approval Date

2025-09-15

218813 / 1

Active Ingredient

GLUCAGON

Application Number

218813

Product Number

1

Dosage Form

-

Strength

1MG/VIAL

Approval Date

2025-09-15

Regulatory Status

RX

2007
10 Sep
RX Application: 65354

Drug Name

GRISEOFULVIN

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

2007-09-10

65354 / 1

Active Ingredient

GRISEOFULVIN, MICROSIZE

Application Number

65354

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

2007-09-10

Regulatory Status

RX

2024
05 Sep
RX Application: 214050

Drug Name

HYDROCORTISONE SODIUM SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2024-09-05

214050 / 1

Active Ingredient

HYDROCORTISONE SODIUM SUCCINATE

Application Number

214050

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2024-09-05

Regulatory Status

RX

2020
13 Jul
RX Application: 212446

Drug Name

ICATIBANT ACETATE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2020-07-13

212446 / 1

Active Ingredient

ICATIBANT ACETATE

Application Number

212446

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2020-07-13

Regulatory Status

RX

2017
03 Mar
RX Application: 77221

Drug Name

LAMIVUDINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2017-03-03

77221 / 1

Active Ingredient

LAMIVUDINE

Application Number

77221

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2017-03-03

Regulatory Status

RX

2017
03 Mar
RX Application: 77221

Drug Name

LAMIVUDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2017-03-03

77221 / 2

Active Ingredient

LAMIVUDINE

Application Number

77221

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2017-03-03

Regulatory Status

RX

2018
07 Sep
RX Application: 77411

Drug Name

LAMIVUDINE AND ZIDOVUDINE

Product Number

1

Dosage Form

-

Strength

150MG;300MG

Approval Date

2018-09-07

77411 / 1

Active Ingredient

LAMIVUDINE; ZIDOVUDINE

Application Number

77411

Product Number

1

Dosage Form

-

Strength

150MG;300MG

Approval Date

2018-09-07

Regulatory Status

RX

2022
06 Sep
RX Application: 210435

Drug Name

LENALIDOMIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2022-09-06

210435 / 1

Active Ingredient

LENALIDOMIDE

Application Number

210435

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2022-09-06

Regulatory Status

RX

2022
06 Sep
RX Application: 210435

Drug Name

LENALIDOMIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2022-09-06

210435 / 2

Active Ingredient

LENALIDOMIDE

Application Number

210435

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2022-09-06

Regulatory Status

RX

2022
06 Sep
RX Application: 210435

Drug Name

LENALIDOMIDE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2022-09-06

210435 / 3

Active Ingredient

LENALIDOMIDE

Application Number

210435

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2022-09-06

Regulatory Status

RX

2022
06 Sep
RX Application: 210435

Drug Name

LENALIDOMIDE

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2022-09-06

210435 / 4

Active Ingredient

LENALIDOMIDE

Application Number

210435

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2022-09-06

Regulatory Status

RX

2023
06 Mar
RX Application: 210435

Drug Name

LENALIDOMIDE

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2023-03-06

210435 / 5

Active Ingredient

LENALIDOMIDE

Application Number

210435

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2023-03-06

Regulatory Status

RX

2026
02 Feb
RX Application: 213165

Drug Name

LENALIDOMIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2026-02-02

213165 / 1

Active Ingredient

LENALIDOMIDE

Application Number

213165

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2026-02-02

Regulatory Status

RX

2026
02 Feb
RX Application: 213165

Drug Name

LENALIDOMIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-02-02

213165 / 2

Active Ingredient

LENALIDOMIDE

Application Number

213165

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-02-02

Regulatory Status

RX

2026
02 Feb
RX Application: 213165

Drug Name

LENALIDOMIDE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2026-02-02

213165 / 3

Active Ingredient

LENALIDOMIDE

Application Number

213165

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2026-02-02

Regulatory Status

RX

2026
02 Feb
RX Application: 213165

Drug Name

LENALIDOMIDE

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2026-02-02

213165 / 4

Active Ingredient

LENALIDOMIDE

Application Number

213165

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2026-02-02

Regulatory Status

RX

2026
02 Feb
RX Application: 213165

Drug Name

LENALIDOMIDE

Product Number

5

Dosage Form

-

Strength

25MG

Approval Date

2026-02-02

213165 / 5

Active Ingredient

LENALIDOMIDE

Application Number

213165

Product Number

5

Dosage Form

-

Strength

25MG

Approval Date

2026-02-02

Regulatory Status

RX

2023
06 Mar
RX Application: 214618

Drug Name

LENALIDOMIDE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2023-03-06

214618 / 1

Active Ingredient

LENALIDOMIDE

Application Number

214618

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2023-03-06

Regulatory Status

RX

2013
13 Dec
RX Application: 78171

Drug Name

LEVALBUTEROL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.0103% BASE

Approval Date

2013-12-13

78171 / 1

Active Ingredient

LEVALBUTEROL HYDROCHLORIDE

Application Number

78171

Product Number

1

Dosage Form

-

Strength

EQ 0.0103% BASE

Approval Date

2013-12-13

Regulatory Status

RX

2013
13 Dec
RX Application: 78171

Drug Name

LEVALBUTEROL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 0.021% BASE

Approval Date

2013-12-13

78171 / 2

Active Ingredient

LEVALBUTEROL HYDROCHLORIDE

Application Number

78171

Product Number

2

Dosage Form

-

Strength

EQ 0.021% BASE

Approval Date

2013-12-13

Regulatory Status

RX

2013
13 Dec
RX Application: 78171

Drug Name

LEVALBUTEROL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 0.042% BASE

Approval Date

2013-12-13

78171 / 3

Active Ingredient

LEVALBUTEROL HYDROCHLORIDE

Application Number

78171

Product Number

3

Dosage Form

-

Strength

EQ 0.042% BASE

Approval Date

2013-12-13

Regulatory Status

RX

2006
19 Jul
RX Application: 77929

Drug Name

MELOXICAM

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2006-07-19

77929 / 1

Active Ingredient

MELOXICAM

Application Number

77929

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2006-07-19

Regulatory Status

RX

2006
19 Jul
RX Application: 77929

Drug Name

MELOXICAM

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2006-07-19

77929 / 2

Active Ingredient

MELOXICAM

Application Number

77929

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2006-07-19

Regulatory Status

RX

2018
26 Oct
RX Application: 207465

Drug Name

METOPROLOL SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG TARTRATE

Approval Date

2018-10-26

207465 / 1

Active Ingredient

METOPROLOL SUCCINATE

Application Number

207465

Product Number

1

Dosage Form

-

Strength

EQ 50MG TARTRATE

Approval Date

2018-10-26

Regulatory Status

RX

2018
26 Oct
RX Application: 207465

Drug Name

METOPROLOL SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

2018-10-26

207465 / 2

Active Ingredient

METOPROLOL SUCCINATE

Application Number

207465

Product Number

2

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

2018-10-26

Regulatory Status

RX

2018
26 Oct
RX Application: 207465

Drug Name

METOPROLOL SUCCINATE

Product Number

3

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

2018-10-26

207465 / 3

Active Ingredient

METOPROLOL SUCCINATE

Application Number

207465

Product Number

3

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

2018-10-26

Regulatory Status

RX

2016
28 Oct
RX Application: 207463

Drug Name

MONTELUKAST SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-10-28

207463 / 1

Active Ingredient

MONTELUKAST SODIUM

Application Number

207463

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-10-28

Regulatory Status

RX

2012
22 May
RX Application: 77956

Drug Name

NEVIRAPINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2012-05-22

77956 / 1

Active Ingredient

NEVIRAPINE

Application Number

77956

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2012-05-22

Regulatory Status

RX

2017
03 Aug
RX Application: 207684

Drug Name

NEVIRAPINE

Product Number

1

Dosage Form

-

Strength

50MG/5ML

Approval Date

2017-08-03

207684 / 1

Active Ingredient

NEVIRAPINE

Application Number

207684

Product Number

1

Dosage Form

-

Strength

50MG/5ML

Approval Date

2017-08-03

Regulatory Status

RX

2024
24 Sep
RX Application: 215592

Drug Name

NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG/200ML (0.1MG/ML)

Approval Date

2024-09-24

215592 / 1

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

215592

Product Number

1

Dosage Form

-

Strength

20MG/200ML (0.1MG/ML)

Approval Date

2024-09-24

Regulatory Status

RX

2024
24 Sep
RX Application: 215592

Drug Name

NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

40MG/200ML (0.2MG/ML)

Approval Date

2024-09-24

215592 / 2

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

215592

Product Number

2

Dosage Form

-

Strength

40MG/200ML (0.2MG/ML)

Approval Date

2024-09-24

Regulatory Status

RX

2025
19 Feb
RX Application: 218922

Drug Name

NILOTINIB D-TARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2025-02-19

218922 / 1

Active Ingredient

NILOTINIB D-TARTRATE

Application Number

218922

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2025-02-19

Regulatory Status

RX

2025
19 Feb
RX Application: 218922

Drug Name

NILOTINIB D-TARTRATE

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2025-02-19

218922 / 2

Active Ingredient

NILOTINIB D-TARTRATE

Application Number

218922

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2025-02-19

Regulatory Status

RX

2025
19 Feb
RX Application: 218922

Drug Name

NILOTINIB D-TARTRATE

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2025-02-19

218922 / 3

Active Ingredient

NILOTINIB D-TARTRATE

Application Number

218922

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2025-02-19

Regulatory Status

RX

2026
02 Apr
RX Application: 212609

Drug Name

NINTEDANIB ESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2026-04-02

212609 / 1

Active Ingredient

NINTEDANIB ESYLATE

Application Number

212609

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2026-04-02

Regulatory Status

RX

2026
02 Apr
RX Application: 212609

Drug Name

NINTEDANIB ESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2026-04-02

212609 / 2

Active Ingredient

NINTEDANIB ESYLATE

Application Number

212609

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2026-04-02

Regulatory Status

RX

2025
10 Apr
RX Application: 209657

Drug Name

PACLITAXEL

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2025-04-10

209657 / 1

Active Ingredient

PACLITAXEL

Application Number

209657

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2025-04-10

Regulatory Status

RX

2025
31 Mar
RX Application: 217458

Drug Name

PANTOPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2025-03-31

217458 / 1

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

217458

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2025-03-31

Regulatory Status

RX

2022
22 Apr
RX Application: 214596

Drug Name

PHYTONADIONE

Product Number

1

Dosage Form

-

Strength

1MG/0.5ML

Approval Date

2022-04-22

214596 / 1

Active Ingredient

PHYTONADIONE

Application Number

214596

Product Number

1

Dosage Form

-

Strength

1MG/0.5ML

Approval Date

2022-04-22

Regulatory Status

RX

2022
22 Apr
RX Application: 214596

Drug Name

PHYTONADIONE

Product Number

2

Dosage Form

-

Strength

10MG/ML

Approval Date

2022-04-22

214596 / 2

Active Ingredient

PHYTONADIONE

Application Number

214596

Product Number

2

Dosage Form

-

Strength

10MG/ML

Approval Date

2022-04-22

Regulatory Status

RX

2025
03 Jan
RX Application: 214966

Drug Name

PHYTONADIONE

Product Number

1

Dosage Form

-

Strength

1MG/0.5ML

Approval Date

2025-01-03

214966 / 1

Active Ingredient

PHYTONADIONE

Application Number

214966

Product Number

1

Dosage Form

-

Strength

1MG/0.5ML

Approval Date

2025-01-03

Regulatory Status

RX

2025
24 Jan
RX Application: 217892

Drug Name

POTASSIUM PHOSPHATES

Product Number

1

Dosage Form

-

Strength

1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)

Approval Date

2025-01-24

217892 / 1

Active Ingredient

POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC

Application Number

217892

Product Number

1

Dosage Form

-

Strength

1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)

Approval Date

2025-01-24

Regulatory Status

RX

2025
24 Jan
RX Application: 217892

Drug Name

POTASSIUM PHOSPHATES

Product Number

2

Dosage Form

-

Strength

3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)

Approval Date

2025-01-24

217892 / 2

Active Ingredient

POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC

Application Number

217892

Product Number

2

Dosage Form

-

Strength

3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)

Approval Date

2025-01-24

Regulatory Status

RX

2025
24 Jan
RX Application: 217892

Drug Name

POTASSIUM PHOSPHATES

Product Number

3

Dosage Form

-

Strength

11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)

Approval Date

2025-01-24

217892 / 3

Active Ingredient

POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC

Application Number

217892

Product Number

3

Dosage Form

-

Strength

11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)

Approval Date

2025-01-24

Regulatory Status

RX

2006
23 Oct
RX Application: 77904

Drug Name

PRAVASTATIN SODIUM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2006-10-23

77904 / 1

Active Ingredient

PRAVASTATIN SODIUM

Application Number

77904

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2006-10-23

Regulatory Status

RX

2006
23 Oct
RX Application: 77904

Drug Name

PRAVASTATIN SODIUM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2006-10-23

77904 / 2

Active Ingredient

PRAVASTATIN SODIUM

Application Number

77904

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2006-10-23

Regulatory Status

RX

2006
23 Oct
RX Application: 77904

Drug Name

PRAVASTATIN SODIUM

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2006-10-23

77904 / 3

Active Ingredient

PRAVASTATIN SODIUM

Application Number

77904

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2006-10-23

Regulatory Status

RX

2016
22 Mar
RX Application: 77904

Drug Name

PRAVASTATIN SODIUM

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2016-03-22

77904 / 4

Active Ingredient

PRAVASTATIN SODIUM

Application Number

77904

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2016-03-22

Regulatory Status

RX

2015
15 Jan
RX Application: 202573

Drug Name

RITONAVIR

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2015-01-15

202573 / 1

Active Ingredient

RITONAVIR

Application Number

202573

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2015-01-15

Regulatory Status

RX

2022
10 May
RX Application: 203759

Drug Name

RITONAVIR

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2022-05-10

203759 / 1

Active Ingredient

RITONAVIR

Application Number

203759

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2022-05-10

Regulatory Status

RX

2021
22 Feb
RX Application: 214209

Drug Name

SUMATRIPTAN

Product Number

1

Dosage Form

-

Strength

20MG/SPRAY

Approval Date

2021-02-22

214209 / 1

Active Ingredient

SUMATRIPTAN

Application Number

214209

Product Number

1

Dosage Form

-

Strength

20MG/SPRAY

Approval Date

2021-02-22

Regulatory Status

RX

2019
26 Mar
RX Application: 209539

Drug Name

TADALAFIL

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2019-03-26

209539 / 1

Active Ingredient

TADALAFIL

Application Number

209539

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2019-03-26

Regulatory Status

RX

2019
26 Mar
RX Application: 209539

Drug Name

TADALAFIL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-03-26

209539 / 2

Active Ingredient

TADALAFIL

Application Number

209539

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-03-26

Regulatory Status

RX

2019
26 Mar
RX Application: 209539

Drug Name

TADALAFIL

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2019-03-26

209539 / 3

Active Ingredient

TADALAFIL

Application Number

209539

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2019-03-26

Regulatory Status

RX

2019
26 Mar
RX Application: 209539

Drug Name

TADALAFIL

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2019-03-26

209539 / 4

Active Ingredient

TADALAFIL

Application Number

209539

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2019-03-26

Regulatory Status

RX

2019
05 Feb
RX Application: 210255

Drug Name

TADALAFIL

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2019-02-05

210255 / 1

Active Ingredient

TADALAFIL

Application Number

210255

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2019-02-05

Regulatory Status

RX

2018
26 Jan
RX Application: 78800

Drug Name

TENOFOVIR DISOPROXIL FUMARATE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2018-01-26

78800 / 1

Active Ingredient

TENOFOVIR DISOPROXIL FUMARATE

Application Number

78800

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2018-01-26

Regulatory Status

RX

2007
02 Jul
RX Application: 77137

Drug Name

TERBINAFINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2007-07-02

77137 / 1

Active Ingredient

TERBINAFINE HYDROCHLORIDE

Application Number

77137

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2007-07-02

Regulatory Status

RX

2018
29 Jan
RX Application: 209533

Drug Name

TESTOSTERONE

Product Number

1

Dosage Form

-

Strength

30MG/1.5ML ACTUATION

Approval Date

2018-01-29

209533 / 1

Active Ingredient

TESTOSTERONE

Application Number

209533

Product Number

1

Dosage Form

-

Strength

30MG/1.5ML ACTUATION

Approval Date

2018-01-29

Regulatory Status

RX

2018
19 Jun
RX Application: 210362

Drug Name

TESTOSTERONE CYPIONATE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2018-06-19

210362 / 1

Active Ingredient

TESTOSTERONE CYPIONATE

Application Number

210362

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2018-06-19

Regulatory Status

RX

2018
19 Jun
RX Application: 210362

Drug Name

TESTOSTERONE CYPIONATE

Product Number

2

Dosage Form

-

Strength

200MG/ML

Approval Date

2018-06-19

210362 / 2

Active Ingredient

TESTOSTERONE CYPIONATE

Application Number

210362

Product Number

2

Dosage Form

-

Strength

200MG/ML

Approval Date

2018-06-19

Regulatory Status

RX

2009
27 Mar
RX Application: 76343

Drug Name

TOPIRAMATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-03-27

76343 / 1

Active Ingredient

TOPIRAMATE

Application Number

76343

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-03-27

Regulatory Status

RX

2009
27 Mar
RX Application: 76343

Drug Name

TOPIRAMATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-03-27

76343 / 2

Active Ingredient

TOPIRAMATE

Application Number

76343

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-03-27

Regulatory Status

RX

2009
27 Mar
RX Application: 76343

Drug Name

TOPIRAMATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-03-27

76343 / 3

Active Ingredient

TOPIRAMATE

Application Number

76343

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-03-27

Regulatory Status

RX

2009
27 Mar
RX Application: 76343

Drug Name

TOPIRAMATE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-03-27

76343 / 4

Active Ingredient

TOPIRAMATE

Application Number

76343

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-03-27

Regulatory Status

RX

2023
06 Dec
RX Application: 217987

Drug Name

VASOPRESSIN

Product Number

1

Dosage Form

-

Strength

20UNITS/100ML (0.2UNITS/ML)

Approval Date

2023-12-06

217987 / 1

Active Ingredient

VASOPRESSIN

Application Number

217987

Product Number

1

Dosage Form

-

Strength

20UNITS/100ML (0.2UNITS/ML)

Approval Date

2023-12-06

Regulatory Status

RX

2008
26 Jun
RX Application: 77981

Drug Name

ZIDOVUDINE

Product Number

1

Dosage Form

-

Strength

50MG/5ML

Approval Date

2008-06-26

77981 / 1

Active Ingredient

ZIDOVUDINE

Application Number

77981

Product Number

1

Dosage Form

-

Strength

50MG/5ML

Approval Date

2008-06-26

Regulatory Status

RX

2007
23 May
RX Application: 78349

Drug Name

ZIDOVUDINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2007-05-23

78349 / 1

Active Ingredient

ZIDOVUDINE

Application Number

78349

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2007-05-23

Regulatory Status

RX

2010
27 Oct
RX Application: 90561

Drug Name

ZIDOVUDINE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2010-10-27

90561 / 1

Active Ingredient

ZIDOVUDINE

Application Number

90561

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2010-10-27

Regulatory Status

RX

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Drug Status Breakdown
140 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

ABACAVIR SULFATE

Application Number

78119

Product Number

1

Active Ingredient

ABACAVIR SULFATE

Dosage Form

-

Strength

EQ 300MG BASE

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

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