← FDA DRUG APPROVALS

FDA NDA · NDA020895

SILDENAFIL CITRATE

Sponsor: VIATRIS

APPLICATION
NDA020895
TYPE
NDA
ORIGINAL APPROVAL
1998-03-27
LATEST ACTION
2017-12-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VIAGRA · ReferencePrescription
SILDENAFIL CITRATE EQ 50MG BASE · TABLET · ORAL
VIAGRA · ReferencePrescription
SILDENAFIL CITRATE EQ 100MG BASE · TABLET · ORAL
VIAGRA · ReferencePrescription
SILDENAFIL CITRATE EQ 25MG BASE · TABLET · ORAL

Approval history

2017-12-14Labeling · Supplement 48 · standard — Label ↗AP
2017-08-17Labeling · Supplement 49 · standard — Label ↗AP
2015-09-16Labeling · Supplement 45 · standard — Letter ↗AP
2015-03-26Labeling · Supplement 44 · standard — Label ↗AP
2015-02-03Manufacturing (CMC) · Supplement 40 · priorityAP
2015-01-26Manufacturing (CMC) · Supplement 43 · priorityAP
2014-03-25Manufacturing (CMC) · Supplement 41 · priorityAP
2014-03-11Efficacy · Supplement 42 · standard — Letter ↗AP
2014-03-11Labeling · Supplement 39 · standard — Letter ↗AP
2011-01-31Labeling · Supplement 36 · standard — Letter ↗AP
2010-01-11Labeling · Supplement 33 · standard — Letter ↗AP
2008-08-06Labeling · Supplement 28 · standard — Letter ↗AP
2008-08-06Labeling · Supplement 29 · standard — Letter ↗AP
2008-02-25Labeling · Supplement 26 · standard — Label ↗AP
2007-10-18Labeling · Supplement 27 · standard — Letter ↗AP
2006-10-06Labeling · Supplement 23 · standard — Label ↗AP
2006-06-26Labeling · Supplement 20 · standard — Label ↗AP
2005-07-08Labeling · Supplement 21 · standard — Label ↗AP
2002-09-19Labeling · Supplement 15 · standard — Label ↗AP
2002-09-19Labeling · Supplement 11 · standard — Letter ↗AP
2002-09-19Efficacy · Supplement 18 · standard — Label ↗AP
2002-02-14Manufacturing (CMC) · Supplement 7 · priorityAP
2002-01-02Labeling · Supplement 12 · standardAP
2001-08-24Manufacturing (CMC) · Supplement 16 · priorityAP
2001-08-24Manufacturing (CMC) · Supplement 14 · priorityAP
2000-03-16Manufacturing (CMC) · Supplement 10 · priorityAP
2000-01-21Labeling · Supplement 5 · standardAP
2000-01-20Manufacturing (CMC) · Supplement 9 · priorityAP
1999-11-16Manufacturing (CMC) · Supplement 8 · priorityAP
1999-06-18Labeling · Supplement 6 · standardAP
1998-12-22Labeling · Supplement 4 · standardAP
1998-11-24Labeling · Supplement 3 · standard — Review ↗AP
1998-08-13Labeling · Supplement 2 · standard — Review ↗AP
1998-05-04Manufacturing (CMC) · Supplement 1 · priority — Review ↗AP
1998-03-27Type 1 - New Molecular Entity · Original · priority — 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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