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Drugs@FDA: FDA-Approved Drugs

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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.html

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	PHARMOBEDIENT
DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Prescription	No	AB	078833	WATSON LABS
DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Prescription	No	AB	202594	XIROMED
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
YAZ	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Prescription	Yes	AB	021676	BAYER HLTHCARE

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