← FDA DRUG APPROVALS

FDA NDA · NDA020628

INVIRASE

Sponsor: HOFFMANN LA ROCHE

APPLICATION
NDA020628
TYPE
NDA
ORIGINAL APPROVAL
1995-12-06
LATEST ACTION
2019-03-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

INVIRASE · ReferenceDiscontinued
SAQUINAVIR MESYLATE EQ 200MG BASE · CAPSULE · ORAL

Approval history

2019-03-28Labeling · Supplement 47 · standard — Letter ↗AP
2018-03-15Labeling · Supplement 46 · standard — Label ↗AP
2016-09-15Labeling · Supplement 45 · 901 required — Letter ↗AP
2016-02-26Labeling · Supplement 41 · standard — Label ↗AP
2016-02-01Manufacturing (CMC) · Supplement 44AP
2015-12-16Labeling · Supplement 43 · standard — Label ↗AP
2015-04-21Labeling · Supplement 39 · standard — Letter ↗AP
2015-03-27Labeling · Supplement 42 · 901 required — Letter ↗AP
2012-11-30Efficacy · Supplement 34 · priority — Pediatric Medical Review ↗AP
2012-02-17Labeling · Supplement 38 · 901 required — Letter ↗AP
2011-05-26REMS · Supplement 37 — Letter ↗AP
2010-10-06Labeling · Supplement 33 · standard — Letter ↗AP
2010-04-27Labeling · Supplement 32 · unknown — Letter ↗AP
2010-01-21Labeling · Supplement 27 · standard — Letter ↗AP
2007-07-11Labeling · Supplement 25 · standard — Letter ↗AP
2007-04-03Labeling · Supplement 24 · standard — Letter ↗AP
2005-09-08Labeling · Supplement 23 · standard — Label ↗AP
2005-09-08Labeling · Supplement 22 · standard — Patient Package Insert ↗AP
2003-12-24Efficacy · Supplement 20 · standard — Label ↗AP
2002-07-02Labeling · Supplement 16 · standard — Label ↗AP
2000-11-14Labeling · Supplement 14 · standardAP
2000-05-11Manufacturing (CMC) · Supplement 15 — Review ↗AP
1999-09-08Manufacturing (CMC) · Supplement 13AP
1999-03-18Manufacturing (CMC) · Supplement 12AP
1999-03-16Manufacturing (CMC) · Supplement 11AP
1998-09-09Manufacturing (CMC) · Supplement 10AP
1998-01-16Labeling · Supplement 9 · standardAP
1997-09-24Manufacturing (CMC) · Supplement 8AP
1997-02-27Labeling · Supplement 7 · standard — Review ↗AP
1996-10-03Manufacturing (CMC) · Supplement 3AP
1996-09-27Efficacy · Supplement 4 · unknownAP
1996-07-31Manufacturing (CMC) · Supplement 5AP
1996-06-26Labeling · Supplement 2 · standardAP
1995-12-06Type 1 - New Molecular Entity · Original · priority — 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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