← FDA DRUG APPROVALS

FDA NDA · NDA020779

VIRACEPT

nelfinavir mesylate

Sponsor: AGOURON PHARMS

APPLICATION
NDA020779
TYPE
NDA
ORIGINAL APPROVAL
1997-03-14
LATEST ACTION
2021-03-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VIRACEPT · ReferencePrescription
NELFINAVIR MESYLATE EQ 250MG BASE · TABLET · ORAL

Approval history

2021-03-24Labeling · Supplement 63 · standard — Letter ↗AP
2016-09-15Labeling · Supplement 62 · 901 required — Label ↗AP
2015-03-27Labeling · Supplement 61 · 901 required — Letter ↗AP
2013-05-28Labeling · Supplement 59 · standard — Letter ↗AP
2012-04-06Labeling · Supplement 57 · standard — Letter ↗AP
2012-02-17Labeling · Supplement 58 · 901 required — Letter ↗AP
2011-02-25Labeling · Supplement 56 · standard — Label ↗AP
2010-04-26Labeling · Supplement 54 · unknown — Label ↗AP
2010-04-26Labeling · Supplement 55 · 901 required — Label ↗AP
2008-11-25Labeling · Supplement 53 · standard — Letter ↗AP
2008-02-13Labeling · Supplement 50 · standard — Letter ↗AP
2007-07-31Labeling · Supplement 48 · standard — Label ↗AP
2006-12-22Labeling · Supplement 46 · standard — Letter ↗AP
2005-09-28Labeling · Supplement 45 · standard — Review ↗AP
2004-06-04Labeling · Supplement 44 · standard — Label ↗AP
2004-03-19Efficacy · Supplement 42 · priority — Review ↗AP
2003-08-27Labeling · Supplement 41 · standard — Letter ↗AP
2002-12-20Labeling · Supplement 39 · standard — Letter ↗AP
2002-02-05Labeling · Supplement 38 · standard — Letter ↗AP
2002-02-05Manufacturing (CMC) · Supplement 37 · priority — Letter ↗AP
2001-10-26Manufacturing (CMC) · Supplement 36 · priority — Review ↗AP
2001-10-26Manufacturing (CMC) · Supplement 35 · priority — Review ↗AP
2001-09-28Manufacturing (CMC) · Supplement 34 · priorityAP
2001-06-19Manufacturing (CMC) · Supplement 33 · priorityAP
2001-04-05Labeling · Supplement 32 · standard — Letter ↗AP
2000-11-08Manufacturing (CMC) · Supplement 31 · priorityAP
2000-09-15Manufacturing (CMC) · Supplement 30 · priorityAP
2000-05-17Efficacy · Supplement 26 · standard — Review ↗AP
2000-03-28Labeling · Supplement 29 · standardAP
2000-02-07Manufacturing (CMC) · Supplement 28 · priorityAP
1999-11-24Efficacy · Supplement 22 · standard — Review ↗AP
1999-11-24Manufacturing (CMC) · Supplement 27 · priorityAP
1999-08-17Manufacturing (CMC) · Supplement 25 · priorityAP
1999-08-06Manufacturing (CMC) · Supplement 24 · priorityAP
1999-07-16Manufacturing (CMC) · Supplement 23 · priorityAP
1999-05-25Labeling · Supplement 20 · standard — Review ↗AP
1999-03-19Manufacturing (CMC) · Supplement 21 · priorityAP
1998-12-01Manufacturing (CMC) · Supplement 19 · priorityAP
1998-10-30Manufacturing (CMC) · Supplement 18 · priorityAP
1998-09-14Manufacturing (CMC) · Supplement 16 · priorityAP
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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