← FDA DRUG APPROVALS

FDA NDA · NDA020933

VIRAMUNE

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA020933
TYPE
NDA
ORIGINAL APPROVAL
1998-09-11
LATEST ACTION
2024-07-22
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued

Products

VIRAMUNE · ReferenceDiscontinued
NEVIRAPINE 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUSPENSION · ORAL

Approval history

2024-07-22Labeling · Supplement 48 · standard — Letter ↗AP
2022-06-10Labeling · Supplement 43 · standard — Letter ↗AP
2018-09-24Labeling · Supplement 40 · standard — Label ↗AP
2017-03-27Labeling · Supplement 38 · standard — Label ↗AP
2015-02-03Manufacturing (CMC) · Supplement 37AP
2014-01-27Labeling · Supplement 35 · standard — Letter ↗AP
2013-02-08Manufacturing (CMC) · Supplement 34AP
2012-11-09Labeling · Supplement 33 · standard — Label ↗AP
2011-11-09Labeling · Supplement 30 · standard — Label ↗AP
2011-05-06REMS · Supplement 29 — Letter ↗AP
2011-03-25Labeling · Supplement 28 · standard — Letter ↗AP
2011-01-07REMS · Supplement 27 — Letter ↗AP
2010-07-20Labeling · Supplement 26 · standard — Letter ↗AP
2010-01-13Labeling · Supplement 22 · standard — Label ↗AP
2008-06-24Efficacy · Supplement 17 · priority — Label ↗AP
2007-08-16Labeling · Supplement 19 · standard — Letter ↗AP
2007-04-13Labeling · Supplement 15 · standard — Letter ↗AP
2005-02-24Labeling · Supplement 14 · standard — Review ↗AP
2004-05-24Labeling · Supplement 12 · standardAP
2003-12-22Labeling · Supplement 11 · standard — Label ↗AP
2003-07-29Labeling · Supplement 10 · standard — Label ↗AP
2002-12-31Labeling · Supplement 6 · standard — Letter ↗AP
2002-12-20Manufacturing (CMC) · Supplement 9AP
2002-03-27Efficacy · Supplement 7 · unknown — Review ↗AP
2001-05-17Manufacturing (CMC) · Supplement 4AP
2001-02-23Manufacturing (CMC) · Supplement 5AP
2000-11-06Labeling · Supplement 3 · standardAP
2000-08-10Labeling · Supplement 2 · standardAP
1999-10-25Labeling · Supplement 1 · standardAP
1998-09-11Type 3 - New Dosage Form · Original · priority — Letter ↗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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