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FDA NDA · NDA202276

STENDRA

Sponsor: VIVUS LLC

APPLICATION
NDA202276
TYPE
NDA
ORIGINAL APPROVAL
2012-04-27
LATEST ACTION
2022-10-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

STENDRA · ReferencePrescription
AVANAFIL 100MG · TABLET · ORAL
STENDRA · ReferencePrescription
AVANAFIL 200MG · TABLET · ORAL
STENDRA · ReferencePrescription
AVANAFIL 50MG · TABLET · ORAL

Approval history

2022-10-18Efficacy · Supplement 20 · standard — Letter ↗AP
2018-08-03Efficacy · Supplement 18 · standard — Label ↗AP
2017-10-10Labeling · Supplement 17 · standard — Label ↗AP
2017-08-16Labeling · Supplement 16 · standard — Label ↗AP
2016-06-15Manufacturing (CMC) · Supplement 14 · standardAP
2015-11-02Manufacturing (CMC) · Supplement 12 · standardAP
2015-09-16Labeling · Supplement 13 · standard — Label ↗AP
2015-05-13Labeling · Supplement 10 · standard — Label ↗AP
2015-03-03Manufacturing (CMC) · Supplement 11 · standardAP
2015-02-09Manufacturing (CMC) · Supplement 9 · standardAP
2014-11-20Manufacturing (CMC) · Supplement 7 · standardAP
2014-09-17Efficacy · Supplement 5 · standard — Label ↗AP
2014-04-29Labeling · Supplement 6 · 901 required — Label ↗AP
2013-08-06Manufacturing (CMC) · Supplement 3 · standardAP
2013-07-10Manufacturing (CMC) · Supplement 4 · standardAP
2012-10-31Labeling · Supplement 1 · standard — Letter ↗AP
2012-04-27Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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