← FDA DRUG APPROVALS

FDA NDA · NDA020685

CRIXIVAN

Sponsor: MERCK SHARP DOHME

APPLICATION
NDA020685
TYPE
NDA
ORIGINAL APPROVAL
1996-03-13
LATEST ACTION
2016-09-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

CRIXIVANDiscontinued
INDINAVIR SULFATE EQ 100MG BASE · CAPSULE · ORAL
CRIXIVANDiscontinued
INDINAVIR SULFATE EQ 333MG BASE · CAPSULE · ORAL
CRIXIVAN · ReferenceDiscontinued
INDINAVIR SULFATE EQ 200MG BASE · CAPSULE · ORAL
CRIXIVAN · ReferenceDiscontinued
INDINAVIR SULFATE EQ 400MG BASE · CAPSULE · ORAL

Approval history

2016-09-15Labeling · Supplement 78 · 901 required — Letter ↗AP
2015-03-27Labeling · Supplement 77 · 901 required — Label ↗AP
2014-07-24Labeling · Supplement 76 · standard — Letter ↗AP
2012-02-17Labeling · Supplement 75 · 901 required — Label ↗AP
2011-06-10Labeling · Supplement 72 · unknown — Letter ↗AP
2010-11-19Labeling · Supplement 73 · unknown — Label ↗AP
2010-04-26Labeling · Supplement 71 · 901 required — Label ↗AP
2009-10-15Labeling · Supplement 69 · standard — Label ↗AP
2008-12-10Labeling · Supplement 68 · standard — Label ↗AP
2008-04-17Labeling · Supplement 66 · standard — Label ↗AP
2008-04-16Labeling · Supplement 65 · standard — Letter ↗AP
2007-07-18Labeling · Supplement 64 · standard — Label ↗AP
2006-12-08Labeling · Supplement 63 · standard — Label ↗AP
2006-08-07Labeling · Supplement 62 · standard — Label ↗AP
2006-01-12Labeling · Supplement 61 · standard — Label ↗AP
2004-12-23Labeling · Supplement 60 · standard — Review ↗AP
2004-05-07Labeling · Supplement 47 · standard — Review ↗AP
2004-05-07Labeling · Supplement 46 · standard — Review ↗AP
2004-01-12Labeling · Supplement 58 · standard — Letter ↗AP
2003-06-09Labeling · Supplement 57 · standard — Letter ↗AP
2002-09-19Labeling · Supplement 55 · standard — Label ↗AP
2002-06-20Labeling · Supplement 56 · standard — Letter ↗AP
2002-01-25Labeling · Supplement 53 · standard — Letter ↗AP
2002-01-25Labeling · Supplement 50 · standard — Letter ↗AP
2001-10-26Manufacturing (CMC) · Supplement 54 · priority — Review ↗AP
2001-09-24Manufacturing (CMC) · Supplement 52 · priority — Review ↗AP
2001-07-13Manufacturing (CMC) · Supplement 51 · priorityAP
2001-07-10Manufacturing (CMC) · Supplement 48 · priorityAP
2001-06-01Manufacturing (CMC) · Supplement 49 · priorityAP
2001-03-21Labeling · Supplement 41 · standard — Review ↗AP
2000-10-23Labeling · Supplement 45 · standardAP
2000-10-23Efficacy · Supplement 43 · standard — Review ↗AP
2000-10-23Labeling · Supplement 40 · standardAP
2000-10-23Labeling · Supplement 30 · standardAP
2000-04-19Manufacturing (CMC) · Supplement 44 · priority — Review ↗AP
2000-04-11Labeling · Supplement 35 · standardAP
2000-04-11Labeling · Supplement 38 · standardAP
2000-04-11Labeling · Supplement 42 · standardAP
1999-10-25Manufacturing (CMC) · Supplement 39 · priorityAP
1999-06-04Labeling · Supplement 27 · standardAP
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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