← FDA DRUG APPROVALS

FDA NDA · NDA021785

INVIRASE

Sponsor: HOFFMANN-LA ROCHE

APPLICATION
NDA021785
TYPE
NDA
ORIGINAL APPROVAL
2004-12-17
LATEST ACTION
2020-09-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

INVIRASE · ReferenceDiscontinued
SAQUINAVIR MESYLATE EQ 500MG BASE · TABLET · ORAL

Approval history

2020-09-18Labeling · Supplement 25 · standard — Letter ↗AP
2019-12-19Labeling · Supplement 24 · standard — Letter ↗AP
2019-03-28Labeling · Supplement 23 · standard — Letter ↗AP
2018-03-15Labeling · Supplement 22 · standard — Label ↗AP
2016-09-15Labeling · Supplement 21 · 901 required — Letter ↗AP
2016-02-26Labeling · Supplement 17 · standard — Label ↗AP
2015-12-16Labeling · Supplement 19 · standard — Label ↗AP
2015-04-21Labeling · Supplement 16 · standard — Label ↗AP
2015-03-27Labeling · Supplement 18 · 901 required — Label ↗AP
2012-11-30Efficacy · Supplement 11 · priority — Letter ↗AP
2012-02-17Labeling · Supplement 15 · 901 required — Letter ↗AP
2011-05-26REMS · Supplement 14 — Letter ↗AP
2010-10-06Labeling · Supplement 10 · standard — Label ↗AP
2010-04-27Labeling · Supplement 9 · unknown — Letter ↗AP
2010-01-21Labeling · Supplement 6 · standard — Label ↗AP
2007-07-11Labeling · Supplement 4 · standard — Letter ↗AP
2007-04-03Labeling · Supplement 3 · standard — Label ↗AP
2005-09-08Labeling · Supplement 2 · standard — Review ↗AP
2005-09-08Labeling · Supplement 1 · standard — Label ↗AP
2004-12-17Type 3 - New Dosage Form · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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