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): 202276
Company: METUCHEN PHARMS

Products on NDA 202276

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
STENDRA	AVANAFIL	50MG	TABLET;ORAL	Prescription	None	Yes	No
STENDRA	AVANAFIL	100MG	TABLET;ORAL	Prescription	None	Yes	No
STENDRA	AVANAFIL	200MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202276

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/27/2012	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202276s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202276s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202276Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/18/2022	SUPPL-20	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202276s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202276Orig1s020ltr.pdf
08/03/2018	SUPPL-18	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202276s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202276Orig1s018ltr.pdf
10/10/2017	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202276s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202276Orig1s017ltr.pdf
08/16/2017	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202276s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202276Orig1s016ltr.pdf
06/15/2016	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
09/16/2015	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202276s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202276Orig1s013ltr.pdf
11/02/2015	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
03/03/2015	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
05/13/2015	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202276s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202276Orig1s010ltr.pdf
02/09/2015	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
11/20/2014	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
04/29/2014	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202276s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202276Orig1s006ltr.pdf
09/17/2014	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202276s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202276Orig1s005ltr.pdf
07/10/2013	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
08/06/2013	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
10/31/2012	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202276s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202276Orig1s001ltr.pdf

Labels for NDA 202276

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/18/2022	SUPPL-20	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202276s020lbl.pdf
08/03/2018	SUPPL-18	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202276s018lbl.pdf
10/10/2017	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202276s017lbl.pdf
08/16/2017	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202276s016lbl.pdf
09/16/2015	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202276s013lbl.pdf
05/13/2015	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202276s010lbl.pdf
09/17/2014	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202276s005lbl.pdf
04/29/2014	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202276s006lbl.pdf
10/31/2012	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202276s001lbl.pdf
04/27/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202276s000lbl.pdf

Top