Bayer AG RX
FDA Approved Drugs

Bayer AG 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 60
  • Latest Approval Date Jun 12, 2026
  • Data Source FDA
  • First Approval Date Oct 22, 1987
All
277
View
Unclassified
23
View
Discontinued
190
View
OTC
4
View
RX
60
View
Company Overview

Company

Bayer AG RX

Country

Germany

Website

Visit Website

Email

pharmachemicals@bayer.com

Social Profiles

Company Snapshot

Bayer AG RX

Mullerstr. 178, 13353 Berlin

Germany

pharma.bayer.com/ pharmachemicals@bayer.com View on Map
FDA Approved Drug Records ( 60 records )
2013
08 Oct
RX Application: 204819

Drug Name

ADEMPAS

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2013-10-08

204819 / 1

Active Ingredient

RIOCIGUAT

Application Number

204819

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2013-10-08

Regulatory Status

RX

2013
08 Oct
RX Application: 204819

Drug Name

ADEMPAS

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2013-10-08

204819 / 2

Active Ingredient

RIOCIGUAT

Application Number

204819

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2013-10-08

Regulatory Status

RX

2013
08 Oct
RX Application: 204819

Drug Name

ADEMPAS

Product Number

3

Dosage Form

-

Strength

1.5MG

Approval Date

2013-10-08

204819 / 3

Active Ingredient

RIOCIGUAT

Application Number

204819

Product Number

3

Dosage Form

-

Strength

1.5MG

Approval Date

2013-10-08

Regulatory Status

RX

2013
08 Oct
RX Application: 204819

Drug Name

ADEMPAS

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2013-10-08

204819 / 4

Active Ingredient

RIOCIGUAT

Application Number

204819

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2013-10-08

Regulatory Status

RX

2013
08 Oct
RX Application: 204819

Drug Name

ADEMPAS

Product Number

5

Dosage Form

-

Strength

2.5MG

Approval Date

2013-10-08

204819 / 5

Active Ingredient

RIOCIGUAT

Application Number

204819

Product Number

5

Dosage Form

-

Strength

2.5MG

Approval Date

2013-10-08

Regulatory Status

RX

2026
12 Jun
RX Application: 219627

Drug Name

AMBELVIST

Product Number

1

Dosage Form

-

Strength

0.5158GM/2ML (257.9MG/ML)

Approval Date

2026-06-12

219627 / 1

Active Ingredient

GADOQUATRANE

Application Number

219627

Product Number

1

Dosage Form

-

Strength

0.5158GM/2ML (257.9MG/ML)

Approval Date

2026-06-12

Regulatory Status

RX

2026
12 Jun
RX Application: 219627

Drug Name

AMBELVIST

Product Number

2

Dosage Form

-

Strength

1.93425GM/7.5ML (257.9MG/ML)

Approval Date

2026-06-12

219627 / 2

Active Ingredient

GADOQUATRANE

Application Number

219627

Product Number

2

Dosage Form

-

Strength

1.93425GM/7.5ML (257.9MG/ML)

Approval Date

2026-06-12

Regulatory Status

RX

2026
12 Jun
RX Application: 219627

Drug Name

AMBELVIST

Product Number

3

Dosage Form

-

Strength

2.579GM/10ML (257.9MG/ML)

Approval Date

2026-06-12

219627 / 3

Active Ingredient

GADOQUATRANE

Application Number

219627

Product Number

3

Dosage Form

-

Strength

2.579GM/10ML (257.9MG/ML)

Approval Date

2026-06-12

Regulatory Status

RX

2026
12 Jun
RX Application: 219627

Drug Name

AMBELVIST

Product Number

4

Dosage Form

-

Strength

3.8685GM/15ML (257.9MG/ML)

Approval Date

2026-06-12

219627 / 4

Active Ingredient

GADOQUATRANE

Application Number

219627

Product Number

4

Dosage Form

-

Strength

3.8685GM/15ML (257.9MG/ML)

Approval Date

2026-06-12

Regulatory Status

RX

2026
12 Jun
RX Application: 219627

Drug Name

AMBELVIST

Product Number

5

Dosage Form

-

Strength

7.737GM/30ML (257.9MG/ML)

Approval Date

2026-06-12

219627 / 5

Active Ingredient

GADOQUATRANE

Application Number

219627

Product Number

5

Dosage Form

-

Strength

7.737GM/30ML (257.9MG/ML)

Approval Date

2026-06-12

Regulatory Status

RX

2026
12 Jun
RX Application: 219627

Drug Name

AMBELVIST

Product Number

6

Dosage Form

-

Strength

16.7635GM/65ML (257.9MG/ML)

Approval Date

2026-06-12

219627 / 6

Active Ingredient

GADOQUATRANE

Application Number

219627

Product Number

6

Dosage Form

-

Strength

16.7635GM/65ML (257.9MG/ML)

Approval Date

2026-06-12

Regulatory Status

RX

2012
29 Feb
RX Application: 21355

Drug Name

ANGELIQ

Product Number

1

Dosage Form

-

Strength

0.25MG;0.5MG

Approval Date

2012-02-29

21355 / 1

Active Ingredient

DROSPIRENONE; ESTRADIOL

Application Number

21355

Product Number

1

Dosage Form

-

Strength

0.25MG;0.5MG

Approval Date

2012-02-29

Regulatory Status

RX

2005
28 Sep
RX Application: 21355

Drug Name

ANGELIQ

Product Number

2

Dosage Form

-

Strength

0.5MG;1MG

Approval Date

2005-09-28

21355 / 2

Active Ingredient

DROSPIRENONE; ESTRADIOL

Application Number

21355

Product Number

2

Dosage Form

-

Strength

0.5MG;1MG

Approval Date

2005-09-28

Regulatory Status

RX

2010
24 Sep
RX Application: 22532

Drug Name

BEYAZ

Product Number

1

Dosage Form

-

Strength

3MG,N/A;0.02MG,N/A;0.451MG,0.451MG

Approval Date

2010-09-24

22532 / 1

Active Ingredient

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

Application Number

22532

Product Number

1

Dosage Form

-

Strength

3MG,N/A;0.02MG,N/A;0.451MG,0.451MG

Approval Date

2010-09-24

Regulatory Status

RX

1987
22 Oct
RX Application: 19537

Drug Name

CIPRO

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1987-10-22

19537 / 2

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

19537

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1987-10-22

Regulatory Status

RX

1987
22 Oct
RX Application: 19537

Drug Name

CIPRO

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1987-10-22

19537 / 3

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

19537

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1987-10-22

Regulatory Status

RX

1997
26 Sep
RX Application: 20780

Drug Name

CIPRO

Product Number

1

Dosage Form

-

Strength

250MG/5ML

Approval Date

1997-09-26

20780 / 1

Active Ingredient

CIPROFLOXACIN

Application Number

20780

Product Number

1

Dosage Form

-

Strength

250MG/5ML

Approval Date

1997-09-26

Regulatory Status

RX

1997
26 Sep
RX Application: 20780

Drug Name

CIPRO

Product Number

2

Dosage Form

-

Strength

500MG/5ML

Approval Date

1997-09-26

20780 / 2

Active Ingredient

CIPROFLOXACIN

Application Number

20780

Product Number

2

Dosage Form

-

Strength

500MG/5ML

Approval Date

1997-09-26

Regulatory Status

RX

1994
22 Dec
RX Application: 20375

Drug Name

CLIMARA

Product Number

1

Dosage Form

-

Strength

0.05MG/24HR

Approval Date

1994-12-22

20375 / 1

Active Ingredient

ESTRADIOL

Application Number

20375

Product Number

1

Dosage Form

-

Strength

0.05MG/24HR

Approval Date

1994-12-22

Regulatory Status

RX

1994
22 Dec
RX Application: 20375

Drug Name

CLIMARA

Product Number

2

Dosage Form

-

Strength

0.1MG/24HR

Approval Date

1994-12-22

20375 / 2

Active Ingredient

ESTRADIOL

Application Number

20375

Product Number

2

Dosage Form

-

Strength

0.1MG/24HR

Approval Date

1994-12-22

Regulatory Status

RX

1998
23 Mar
RX Application: 20375

Drug Name

CLIMARA

Product Number

3

Dosage Form

-

Strength

0.075MG/24HR

Approval Date

1998-03-23

20375 / 3

Active Ingredient

ESTRADIOL

Application Number

20375

Product Number

3

Dosage Form

-

Strength

0.075MG/24HR

Approval Date

1998-03-23

Regulatory Status

RX

1999
05 Mar
RX Application: 20375

Drug Name

CLIMARA

Product Number

4

Dosage Form

-

Strength

0.025MG/24HR

Approval Date

1999-03-05

20375 / 4

Active Ingredient

ESTRADIOL

Application Number

20375

Product Number

4

Dosage Form

-

Strength

0.025MG/24HR

Approval Date

1999-03-05

Regulatory Status

RX

2003
27 May
RX Application: 20375

Drug Name

CLIMARA

Product Number

5

Dosage Form

-

Strength

0.0375MG/24HR

Approval Date

2003-05-27

20375 / 5

Active Ingredient

ESTRADIOL

Application Number

20375

Product Number

5

Dosage Form

-

Strength

0.0375MG/24HR

Approval Date

2003-05-27

Regulatory Status

RX

2003
27 May
RX Application: 20375

Drug Name

CLIMARA

Product Number

6

Dosage Form

-

Strength

0.06MG/24HR

Approval Date

2003-05-27

20375 / 6

Active Ingredient

ESTRADIOL

Application Number

20375

Product Number

6

Dosage Form

-

Strength

0.06MG/24HR

Approval Date

2003-05-27

Regulatory Status

RX

2003
21 Nov
RX Application: 21258

Drug Name

CLIMARA PRO

Product Number

1

Dosage Form

-

Strength

0.045MG/24HR;0.015MG/24HR

Approval Date

2003-11-21

21258 / 1

Active Ingredient

ESTRADIOL; LEVONORGESTREL

Application Number

21258

Product Number

1

Dosage Form

-

Strength

0.045MG/24HR;0.015MG/24HR

Approval Date

2003-11-21

Regulatory Status

RX

2008
03 Jul
RX Application: 22090

Drug Name

EOVIST

Product Number

1

Dosage Form

-

Strength

1.8143GM/10ML (181.43MG/ML)

Approval Date

2008-07-03

22090 / 1

Active Ingredient

GADOXETATE DISODIUM

Application Number

22090

Product Number

1

Dosage Form

-

Strength

1.8143GM/10ML (181.43MG/ML)

Approval Date

2008-07-03

Regulatory Status

RX

2013
04 Feb
RX Application: 22090

Drug Name

EOVIST

Product Number

2

Dosage Form

-

Strength

2.72145GM/15ML (181.43MG/ML)

Approval Date

2013-02-04

22090 / 2

Active Ingredient

GADOXETATE DISODIUM

Application Number

22090

Product Number

2

Dosage Form

-

Strength

2.72145GM/15ML (181.43MG/ML)

Approval Date

2013-02-04

Regulatory Status

RX

2011
14 Mar
RX Application: 201277

Drug Name

GADAVIST

Product Number

1

Dosage Form

-

Strength

4.5354GM/7.5ML (604.72MG/ML)

Approval Date

2011-03-14

201277 / 1

Active Ingredient

GADOBUTROL

Application Number

201277

Product Number

1

Dosage Form

-

Strength

4.5354GM/7.5ML (604.72MG/ML)

Approval Date

2011-03-14

Regulatory Status

RX

2011
14 Mar
RX Application: 201277

Drug Name

GADAVIST

Product Number

2

Dosage Form

-

Strength

6.0472GM/10ML (604.72MG/ML)

Approval Date

2011-03-14

201277 / 2

Active Ingredient

GADOBUTROL

Application Number

201277

Product Number

2

Dosage Form

-

Strength

6.0472GM/10ML (604.72MG/ML)

Approval Date

2011-03-14

Regulatory Status

RX

2011
14 Mar
RX Application: 201277

Drug Name

GADAVIST

Product Number

3

Dosage Form

-

Strength

9.0708GM/15ML (604.72MG/ML)

Approval Date

2011-03-14

201277 / 3

Active Ingredient

GADOBUTROL

Application Number

201277

Product Number

3

Dosage Form

-

Strength

9.0708GM/15ML (604.72MG/ML)

Approval Date

2011-03-14

Regulatory Status

RX

2011
14 Mar
RX Application: 201277

Drug Name

GADAVIST

Product Number

4

Dosage Form

-

Strength

18.1416GM/30ML (604.72MG/ML)

Approval Date

2011-03-14

201277 / 4

Active Ingredient

GADOBUTROL

Application Number

201277

Product Number

4

Dosage Form

-

Strength

18.1416GM/30ML (604.72MG/ML)

Approval Date

2011-03-14

Regulatory Status

RX

2011
14 Mar
RX Application: 201277

Drug Name

GADAVIST

Product Number

5

Dosage Form

-

Strength

39.3068GM/65ML (604.72MG/ML)

Approval Date

2011-03-14

201277 / 5

Active Ingredient

GADOBUTROL

Application Number

201277

Product Number

5

Dosage Form

-

Strength

39.3068GM/65ML (604.72MG/ML)

Approval Date

2011-03-14

Regulatory Status

RX

2013
18 Dec
RX Application: 201277

Drug Name

GADAVIST

Product Number

6

Dosage Form

-

Strength

1.20944GM/2ML (604.72MG/ML)

Approval Date

2013-12-18

201277 / 6

Active Ingredient

GADOBUTROL

Application Number

201277

Product Number

6

Dosage Form

-

Strength

1.20944GM/2ML (604.72MG/ML)

Approval Date

2013-12-18

Regulatory Status

RX

2025
19 Nov
RX Application: 219972

Drug Name

HYRNUO

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2025-11-19

219972 / 1

Active Ingredient

SEVABERTINIB

Application Number

219972

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2025-11-19

Regulatory Status

RX

2021
09 Jul
RX Application: 215341

Drug Name

KERENDIA

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-07-09

215341 / 1

Active Ingredient

FINERENONE

Application Number

215341

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-07-09

Regulatory Status

RX

2021
09 Jul
RX Application: 215341

Drug Name

KERENDIA

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2021-07-09

215341 / 2

Active Ingredient

FINERENONE

Application Number

215341

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2021-07-09

Regulatory Status

RX

2025
11 Jul
RX Application: 215341

Drug Name

KERENDIA

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2025-07-11

215341 / 3

Active Ingredient

FINERENONE

Application Number

215341

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2025-07-11

Regulatory Status

RX

2016
16 Sep
RX Application: 208224

Drug Name

KYLEENA

Product Number

1

Dosage Form

-

Strength

19.5MG

Approval Date

2016-09-16

208224 / 1

Active Ingredient

LEVONORGESTREL

Application Number

208224

Product Number

1

Dosage Form

-

Strength

19.5MG

Approval Date

2016-09-16

Regulatory Status

RX

2020
06 Aug
RX Application: 213464

Drug Name

LAMPIT

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2020-08-06

213464 / 1

Active Ingredient

NIFURTIMOX

Application Number

213464

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2020-08-06

Regulatory Status

RX

2020
06 Aug
RX Application: 213464

Drug Name

LAMPIT

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2020-08-06

213464 / 2

Active Ingredient

NIFURTIMOX

Application Number

213464

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2020-08-06

Regulatory Status

RX

2025
24 Oct
RX Application: 219469

Drug Name

LYNKUET

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2025-10-24

219469 / 1

Active Ingredient

ELINZANETANT

Application Number

219469

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2025-10-24

Regulatory Status

RX

2004
08 Jun
RX Application: 21674

Drug Name

MENOSTAR

Product Number

1

Dosage Form

-

Strength

0.014MG/24HR

Approval Date

2004-06-08

21674 / 1

Active Ingredient

ESTRADIOL

Application Number

21674

Product Number

1

Dosage Form

-

Strength

0.014MG/24HR

Approval Date

2004-06-08

Regulatory Status

RX

2000
06 Dec
RX Application: 21225

Drug Name

MIRENA

Product Number

1

Dosage Form

-

Strength

52MG

Approval Date

2000-12-06

21225 / 1

Active Ingredient

LEVONORGESTREL

Application Number

21225

Product Number

1

Dosage Form

-

Strength

52MG

Approval Date

2000-12-06

Regulatory Status

RX

2010
06 May
RX Application: 22252

Drug Name

NATAZIA

Product Number

1

Dosage Form

-

Strength

N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A

Approval Date

2010-05-06

22252 / 1

Active Ingredient

DIENOGEST; ESTRADIOL VALERATE

Application Number

22252

Product Number

1

Dosage Form

-

Strength

N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A

Approval Date

2010-05-06

Regulatory Status

RX

2005
20 Dec
RX Application: 21923

Drug Name

NEXAVAR

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2005-12-20

21923 / 1

Active Ingredient

SORAFENIB TOSYLATE

Application Number

21923

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2005-12-20

Regulatory Status

RX

2006
15 Sep
RX Application: 22003

Drug Name

NOXAFIL

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2006-09-15

22003 / 1

Active Ingredient

POSACONAZOLE

Application Number

22003

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2006-09-15

Regulatory Status

RX

2019
30 Jul
RX Application: 212099

Drug Name

NUBEQA

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2019-07-30

212099 / 1

Active Ingredient

DAROLUTAMIDE

Application Number

212099

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2019-07-30

Regulatory Status

RX

2010
16 Dec
RX Application: 22574

Drug Name

SAFYRAL

Product Number

1

Dosage Form

-

Strength

3MG,N/A;0.03MG,N/A;0.451MG,0.451MG

Approval Date

2010-12-16

22574 / 1

Active Ingredient

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

Application Number

22574

Product Number

1

Dosage Form

-

Strength

3MG,N/A;0.03MG,N/A;0.451MG,0.451MG

Approval Date

2010-12-16

Regulatory Status

RX

2013
09 Jan
RX Application: 203159

Drug Name

SKYLA

Product Number

1

Dosage Form

-

Strength

13.5MG

Approval Date

2013-01-09

203159 / 1

Active Ingredient

LEVONORGESTREL

Application Number

203159

Product Number

1

Dosage Form

-

Strength

13.5MG

Approval Date

2013-01-09

Regulatory Status

RX

2012
27 Sep
RX Application: 203085

Drug Name

STIVARGA

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2012-09-27

203085 / 1

Active Ingredient

REGORAFENIB

Application Number

203085

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2012-09-27

Regulatory Status

RX

2002
20 Sep
RX Application: 21425

Drug Name

ULTRAVIST (PHARMACY BULK)

Product Number

1

Dosage Form

-

Strength

62.3%

Approval Date

2002-09-20

21425 / 1

Active Ingredient

IOPROMIDE

Application Number

21425

Product Number

1

Dosage Form

-

Strength

62.3%

Approval Date

2002-09-20

Regulatory Status

RX

2002
20 Sep
RX Application: 21425

Drug Name

ULTRAVIST (PHARMACY BULK)

Product Number

2

Dosage Form

-

Strength

76.9%

Approval Date

2002-09-20

21425 / 2

Active Ingredient

IOPROMIDE

Application Number

21425

Product Number

2

Dosage Form

-

Strength

76.9%

Approval Date

2002-09-20

Regulatory Status

RX

1995
10 May
RX Application: 20220

Drug Name

ULTRAVIST 300

Product Number

2

Dosage Form

-

Strength

62.3%

Approval Date

1995-05-10

20220 / 2

Active Ingredient

IOPROMIDE

Application Number

20220

Product Number

2

Dosage Form

-

Strength

62.3%

Approval Date

1995-05-10

Regulatory Status

RX

1995
10 May
RX Application: 20220

Drug Name

ULTRAVIST 370

Product Number

1

Dosage Form

-

Strength

76.9%

Approval Date

1995-05-10

20220 / 1

Active Ingredient

IOPROMIDE

Application Number

20220

Product Number

1

Dosage Form

-

Strength

76.9%

Approval Date

1995-05-10

Regulatory Status

RX

2018
26 Nov
RX Application: 210861

Drug Name

VITRAKVI

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2018-11-26

210861 / 1

Active Ingredient

LAROTRECTINIB SULFATE

Application Number

210861

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2018-11-26

Regulatory Status

RX

2018
26 Nov
RX Application: 210861

Drug Name

VITRAKVI

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2018-11-26

210861 / 2

Active Ingredient

LAROTRECTINIB SULFATE

Application Number

210861

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2018-11-26

Regulatory Status

RX

2018
26 Nov
RX Application: 211710

Drug Name

VITRAKVI

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

2018-11-26

211710 / 1

Active Ingredient

LAROTRECTINIB SULFATE

Application Number

211710

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

2018-11-26

Regulatory Status

RX

2013
15 May
RX Application: 203971

Drug Name

XOFIGO

Product Number

1

Dosage Form

-

Strength

162mCi/6ML (27mCi/ML)

Approval Date

2013-05-15

203971 / 1

Active Ingredient

RADIUM RA-223 DICHLORIDE

Application Number

203971

Product Number

1

Dosage Form

-

Strength

162mCi/6ML (27mCi/ML)

Approval Date

2013-05-15

Regulatory Status

RX

2001
11 May
RX Application: 21098

Drug Name

YASMIN

Product Number

1

Dosage Form

-

Strength

3MG;0.03MG

Approval Date

2001-05-11

21098 / 1

Active Ingredient

DROSPIRENONE; ETHINYL ESTRADIOL

Application Number

21098

Product Number

1

Dosage Form

-

Strength

3MG;0.03MG

Approval Date

2001-05-11

Regulatory Status

RX

2006
16 Mar
RX Application: 21676

Drug Name

YAZ

Product Number

1

Dosage Form

-

Strength

3MG;0.02MG

Approval Date

2006-03-16

21676 / 1

Active Ingredient

DROSPIRENONE; ETHINYL ESTRADIOL

Application Number

21676

Product Number

1

Dosage Form

-

Strength

3MG;0.02MG

Approval Date

2006-03-16

Regulatory Status

RX

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Drug Status Breakdown
60 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

ADEMPAS

Application Number

204819

Product Number

1

Active Ingredient

RIOCIGUAT

Dosage Form

-

Strength

0.5MG

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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