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FDA NDA · NDA020972

SUSTIVA

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
NDA020972
TYPE
NDA
ORIGINAL APPROVAL
1998-09-17
LATEST ACTION
2023-11-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

SUSTIVA · ReferenceDiscontinued
EFAVIRENZ 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
SUSTIVA · ReferenceDiscontinued
EFAVIRENZ 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
SUSTIVA · ReferenceDiscontinued
EFAVIRENZ 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2023-11-08Labeling · Supplement 59 · standard — Label ↗AP
2019-10-29Labeling · Supplement 57 · standard — Letter ↗AP
2017-10-10Labeling · Supplement 56 · standard — Label ↗AP
2017-01-30Labeling · Supplement 54 · standard — Letter ↗AP
2016-10-12Labeling · Supplement 53 · standard — Label ↗AP
2016-08-31Labeling · Supplement 51 · standard — Letter ↗AP
2016-06-03Manufacturing (CMC) · Supplement 50 · priorityAP
2016-03-31Labeling · Supplement 49 · standard — Letter ↗AP
2015-03-27Labeling · Supplement 48 · standard — Label ↗AP
2014-08-14Manufacturing (CMC) · Supplement 47 · priorityAP
2014-05-23Labeling · Supplement 46 · standard — Letter ↗AP
2014-01-22Manufacturing (CMC) · Supplement 45 · priorityAP
2014-01-15Manufacturing (CMC) · Supplement 44 · priorityAP
2013-05-02Efficacy · Supplement 43 · priority — Label ↗AP
2012-08-10Labeling · Supplement 42 · 901 required — Letter ↗AP
2012-06-22Labeling · Supplement 41 · standard — Letter ↗AP
2011-12-19Labeling · Supplement 40 · unknown — Label ↗AP
2011-09-26Labeling · Supplement 38 · unknown — Pediatric Written Request ↗AP
2010-11-30Labeling · Supplement 36 · standard — Label ↗AP
2010-03-31Labeling · Supplement 35 · unknown — Label ↗AP
2009-09-23Labeling · Supplement 33 · standard — Letter ↗AP
2009-03-11Labeling · Supplement 31 · standard — Label ↗AP
2008-08-18Labeling · Supplement 30 · standard — Letter ↗AP
2007-01-24Labeling · Supplement 29 · standard — Label ↗AP
2006-03-28Labeling · Supplement 27 · standard — Letter ↗AP
2005-04-20Labeling · Supplement 26 · standard — Label ↗AP
2004-10-22Labeling · Supplement 24 · standard — Label ↗AP
2004-08-13Efficacy · Supplement 22 · unknown — Review ↗AP
2003-11-13Labeling · Supplement 21 · standard — Label ↗AP
2003-06-10Labeling · Supplement 19 · standard — Label ↗AP
2003-06-10Labeling · Supplement 18 · standard — Label ↗AP
2003-01-29Labeling · Supplement 16 · standard — Letter ↗AP
2002-09-20Labeling · Supplement 17 · standard — Letter ↗AP
2002-03-01Labeling · Supplement 7 · standard — Letter ↗AP
2002-02-28Manufacturing (CMC) · Supplement 14 · priority — Review ↗AP
2001-11-21Manufacturing (CMC) · Supplement 12 · priorityAP
2001-10-16Labeling · Supplement 13 · standard — Label ↗AP
2001-05-16Manufacturing (CMC) · Supplement 9 · priorityAP
2001-04-12Manufacturing (CMC) · Supplement 8 · priorityAP
2000-11-14Labeling · Supplement 6 · standardAP
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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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