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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022252
Company: BAYER HLTHCARE

Summary Review

Products on NDA 022252

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NATAZIA	DIENOGEST; ESTRADIOL VALERATE	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022252

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/14/2012	ORIG-2	Approval	Efficacy	STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022252s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022252Orig2s000ltr.pdf
05/06/2010	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022252s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022252s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022252_Orig-1TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022252_Orig-1_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022252s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022252Orig1s007ltr.pdf
08/21/2015	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022252s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022252Orig1s004ltr.pdf
08/22/2013	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022252s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022252Orig1s003ltr.pdf
02/13/2012	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022252s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022252s001ltr.pdf

Labels for NDA 022252

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022252s007lbl.pdf
08/21/2015	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022252s004lbl.pdf
08/22/2013	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022252s003lbl.pdf
03/14/2012	ORIG-2	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022252s002lbl.pdf
02/13/2012	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022252s001lbl.pdf
05/06/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022252s000lbl.pdf

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