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FDA NDA · NDA020778

VIRACEPT

Sponsor: AGOURON PHARMS

APPLICATION
NDA020778
TYPE
NDA
ORIGINAL APPROVAL
1997-03-14
LATEST ACTION
2021-03-24
ROUTE
ORAL
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

VIRACEPTDiscontinued
NELFINAVIR MESYLATE EQ 50MG BASE/SCOOPFUL · POWDER · ORAL

Approval history

2021-03-24Labeling · Supplement 42 · standard — Letter ↗AP
2016-09-15Labeling · Supplement 41 · 901 required — Label ↗AP
2015-03-27Labeling · Supplement 40 · 901 required — Letter ↗AP
2013-05-28Labeling · Supplement 38 · standard — Letter ↗AP
2012-04-06Labeling · Supplement 36 · standard — Label ↗AP
2012-02-17Labeling · Supplement 37 · 901 order — Letter ↗AP
2011-02-25Labeling · Supplement 35 · standard — Label ↗AP
2010-04-26Labeling · Supplement 33 · unknown — Label ↗AP
2010-04-26Labeling · Supplement 34 · 901 required — Letter ↗AP
2008-11-25Labeling · Supplement 32 · standard — Letter ↗AP
2008-02-13Labeling · Supplement 29 · standard — Letter ↗AP
2007-07-31Labeling · Supplement 27 · standard — Label ↗AP
2006-12-22Labeling · Supplement 25 · standard — Label ↗AP
2005-09-28Labeling · Supplement 24 · standard — Letter ↗AP
2004-06-04Labeling · Supplement 23 · standard — Label ↗AP
2004-03-19Efficacy · Supplement 22 · priority — Label ↗AP
2003-08-27Labeling · Supplement 20 · standard — Letter ↗AP
2002-12-20Labeling · Supplement 18 · standard — Letter ↗AP
2002-02-05Labeling · Supplement 17 · standard — Letter ↗AP
2002-02-05Manufacturing (CMC) · Supplement 16 · priority — Letter ↗AP
2001-12-21Manufacturing (CMC) · Supplement 15 · priority — Review ↗AP
2001-04-05Labeling · Supplement 14 · standard — Letter ↗AP
2000-05-17Efficacy · Supplement 12 · standard — Review ↗AP
2000-03-28Labeling · Supplement 13 · standardAP
1999-11-24Efficacy · Supplement 11 · standardAP
1999-05-25Labeling · Supplement 10 · standard — Review ↗AP
1998-10-30Manufacturing (CMC) · Supplement 9 · priorityAP
1998-04-24Manufacturing (CMC) · Supplement 7 · priorityAP
1997-12-19Manufacturing (CMC) · Supplement 5 · priorityAP
1997-10-06Manufacturing (CMC) · Supplement 4 · priorityAP
1997-09-30Labeling · Supplement 6 · standardAP
1997-07-31Labeling · Supplement 3 · standardAP
1997-06-04Manufacturing (CMC) · Supplement 2 · priorityAP
1997-03-14Type 3 - New Dosage Form · Original · priority — Pediatric Medical Review ↗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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