An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021676
Company: BAYER HLTHCARE

Other Important Information from FDA

Products on NDA 021676

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
YAZ	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021676

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/16/2006	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021676s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021676s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021676s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021676s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021676Orig1s021ltr.pdf
05/19/2023	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021676s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021676Orig1s020ltr.pdf
08/09/2017	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021676s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021676Orig1s019ltr.pdf
07/31/2015	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
09/30/2014	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
03/04/2016	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
06/01/2015	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021676s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021098Orig1s023,022532Orig1s006,022574Orig1s006,021676Orig1s014ltr.pdf
01/31/2013	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
04/10/2012	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021676s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s022,021676s012,022532s004,022574s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021676Orig1s012.pdf
04/07/2010	SUPPL-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021676s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021676s009ltr.pdf
03/11/2011	SUPPL-8	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021676s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021676s008ltr.pdf
01/26/2007	SUPPL-2	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021676s002ltr.pdf

Labels for NDA 021676

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/19/2023	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021676s020lbl.pdf
04/29/2022	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021676s021lbl.pdf
08/09/2017	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021676s019lbl.pdf
06/01/2015	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021676s014lbl.pdf
04/10/2012	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021676s012lbl.pdf
03/11/2011	SUPPL-8	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021676s008lbl.pdf
04/07/2010	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021676s009lbl.pdf
03/16/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021676s000lbl.pdf

Therapeutic Equivalents for NDA 021676

YAZ

TABLET;ORAL; 3MG;0.02MG
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;0.02MG	TABLET;ORAL	Prescription	No	AB	204296	GLENMARK PHARMS LTD
DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Prescription	No	AB	211944	HETERO LABS
DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Prescription	No	AB	203291	HLTHCARE
DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Prescription	No	AB	202594	MYLAN LABS LTD
DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Prescription	No	AB	078833	WATSON LABS
LO-ZUMANDIMINE	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Prescription	No	AB	209632	AUROBINDO PHARMA LTD
LORYNA	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Prescription	No	AB	079221	XIROMED
MELAMISA	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Prescription	No	AB	202016	NOVAST LABS
NIKKI	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Prescription	No	AB	201661	LUPIN LTD
YAZ	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Prescription	Yes	AB	021676	BAYER HLTHCARE

Top