← FDA DRUG APPROVALS

FDA NDA · NDA021845

REVATIO

sildenafil citrate

Sponsor: VIATRIS

APPLICATION
NDA021845
TYPE
NDA
ORIGINAL APPROVAL
2005-06-03
LATEST ACTION
2024-12-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

REVATIO · ReferencePrescription
SILDENAFIL CITRATE EQ 20MG BASE · TABLET · ORAL

Approval history

2024-12-16Manufacturing (CMC) · Supplement 28 — Label ↗AP
2023-01-31Efficacy · Supplement 25 · standard — Letter ↗AP
2018-02-01Labeling · Supplement 18 · standard — Label ↗AP
2017-07-31Labeling · Supplement 20 · standard — Label ↗AP
2015-04-27Labeling · Supplement 16 · standard — Letter ↗AP
2015-02-03Manufacturing (CMC) · Supplement 9 · priorityAP
2014-03-11Labeling · Supplement 11 · standard — Label ↗AP
2014-03-06Labeling · Supplement 14 · standard — Label ↗AP
2014-01-31Labeling · Supplement 13 · standard — Letter ↗AP
2014-01-31Efficacy · Supplement 12 · standard — Label ↗AP
2012-08-30Efficacy · Supplement 8 · standard — Label ↗AP
2010-11-19Labeling · Supplement 7 · unknown — Letter ↗AP
2009-05-07Efficacy · Supplement 6 · standard — Letter ↗AP
2009-02-17Labeling · Supplement 5 · standard — Label ↗AP
2007-12-18Labeling · Supplement 4 · standard — Letter ↗AP
2006-07-27Labeling · Supplement 2 · standard — Patient Information Sheet ↗AP
2006-07-19Labeling · Supplement 3 · standard — Letter ↗AP
2005-11-03Labeling · Supplement 1 · standard — Letter ↗AP
2005-06-03Type 5 - New Formulation or New Manufacturer · Original · priority — Other Important Information from FDA ↗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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