Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022532
Company: BAYER HLTHCARE

• Other Important Information from FDA

• Summary Review

Products on NDA 22532

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BEYAZ	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Labels for NDA 022532

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/19/2023	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022532s010lbl.pdf
04/29/2022	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022532s011lbl.pdf
08/09/2017	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022532s009lbl.pdf
06/01/2015	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022532s006lbl.pdf
04/10/2012	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022532s004lbl.pdf
02/13/2012	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022532s001lbl.pdf
09/24/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022532s000lbl.pdf