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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 200179
Company: BAYER HLTHCARE

Products on NDA 200179

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
STAXYN	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 200179

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/17/2010	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200179lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200179s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200179_staxyn_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/24/2023	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/200179s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/200179Orig1s007ltr.pdf
08/16/2017	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200179s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200179Orig1s005ltr.pdf
08/02/2017	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200179s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200179Orig1s004ltr.pdf
09/16/2015	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200179s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200179Orig1s003ltr.pdf
04/29/2014	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200179s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200179Orig1s002ltr.pdf
08/02/2013	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200179s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200179Orig1s001ltr.pdf

Labels for NDA 200179

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/24/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/200179s007lbl.pdf
08/16/2017	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200179s005lbl.pdf
08/02/2017	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200179s004lbl.pdf
09/16/2015	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200179s003lbl.pdf
04/29/2014	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200179s002lbl.pdf
08/02/2013	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200179s001lbl.pdf
06/17/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200179lbl.pdf

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