Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202276
Company: METUCHEN PHARMS
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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