Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021098
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
YASMIN DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/11/2001 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21098lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-098_Yasmin_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-098_Yasmin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021098s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021098Orig1s028ltr.pdf
03/08/2016 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/30/2014 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

11/26/2014 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

06/01/2015 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021098s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021098Orig1s023,022532Orig1s006,022574Orig1s006,021676Orig1s014ltr.pdf
04/10/2012 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021098s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s022,021676s012,022532s004,022574s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021098Orig1s022.pdf
01/31/2013 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/13/2012 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021098s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s019ltr.pdf
04/07/2010 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021098s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021098s017ltr.pdf
08/08/2002 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/09/2003 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021098s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21098se8-005ltr.pdf
12/12/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/2001 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/30/2001 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/26/2001 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/09/2017 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021098s028lbl.pdf
06/01/2015 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021098s023lbl.pdf
04/10/2012 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021098s022lbl.pdf
02/13/2012 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021098s019lbl.pdf
04/07/2010 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021098s017lbl.pdf
05/09/2003 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021098s005lbl.pdf
05/11/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21098lbl.pdf

YASMIN

TABLET;ORAL-28; 3MG;0.03MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription No AB 207245 ACCORD HLTHCARE
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription No AB 205876 APOTEX
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription No AB 077527 BARR
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription No AB 204848 GLENMARK PHARMS LTD
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription No AB 210017 JUBILANT CADISTA
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription No AB 201663 LUPIN LTD
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription No AB 090081 MAYNE PHARMA
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription No AB 202131 MYLAN LABS LTD
KEMEYA DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription No AB 202138 SUN PHARM
SYEDA DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription No AB 090114 XIROMED
YAELA DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription No AB 202015 NOVAST LABS
YASMIN DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription Yes AB 021098 BAYER HLTHCARE
ZUMANDIMINE DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription No AB 209407 AUROBINDO PHARMA LTD

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English