FDA NDA · NDA020636

VIRAMUNE

Sponsor: BOEHRINGER INGELHEIM

APPLICATION

NDA020636

TYPE

NDA

ORIGINAL APPROVAL

1996-06-21

LATEST ACTION

2022-06-10

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

VIRAMUNE · ReferenceDiscontinued

NEVIRAPINE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2022-06-10Labeling · Supplement 52 · standard — Letter ↗AP

2018-09-24Labeling · Supplement 50 · standard — Label ↗AP

2017-03-27Labeling · Supplement 48 · standard — Label ↗AP

2016-04-14Manufacturing (CMC) · Supplement 47 · priorityAP

2014-01-27Labeling · Supplement 44 · standard — Label ↗AP

2012-11-09Labeling · Supplement 42 · standard — Letter ↗AP

2011-11-09Labeling · Supplement 39 · standard — Letter ↗AP

2011-05-06REMS · Supplement 38 — Letter ↗AP

2011-03-25Labeling · Supplement 37 · standard — Label ↗AP

2011-01-07REMS · Supplement 36 — Letter ↗AP

2010-07-20Labeling · Supplement 35 · standard — Letter ↗AP

2010-01-13Labeling · Supplement 32 · standard — Label ↗AP

2008-06-24Efficacy · Supplement 27 · priority — Letter ↗AP

2007-08-16Labeling · Supplement 29 · standard — Letter ↗AP

2007-04-13Labeling · Supplement 26 · standard — Label ↗AP

2005-02-24Labeling · Supplement 25 · standard — Review ↗AP

2004-05-24Labeling · Supplement 22 · standard — Label ↗AP

2003-12-22Labeling · Supplement 21 · standard — Label ↗AP

2003-07-29Labeling · Supplement 20 · standard — Label ↗AP

2002-12-31Labeling · Supplement 16 · standard — Letter ↗AP

2002-12-18Manufacturing (CMC) · Supplement 19 · priorityAP

2002-03-27Efficacy · Supplement 17 · unknown — Review ↗AP

2001-02-23Manufacturing (CMC) · Supplement 15 · priorityAP

2000-11-06Labeling · Supplement 14 · standardAP

2000-08-10Labeling · Supplement 13 · standardAP

1999-10-25Labeling · Supplement 11 · standardAP

1999-08-05Manufacturing (CMC) · Supplement 12 · priority — Review ↗AP

1999-06-01Manufacturing (CMC) · Supplement 10 · priorityAP

1998-09-11Efficacy · Supplement 9 · standard — Review ↗AP

1998-05-20Efficacy · Supplement 2 · standard — Review ↗AP

1998-05-20Labeling · Supplement 7 · standard — Review ↗AP

1998-01-16Manufacturing (CMC) · Supplement 3 · priorityAP

1997-11-21Manufacturing (CMC) · Supplement 1 · priorityAP

1997-09-24Manufacturing (CMC) · Supplement 4 · priorityAP

1997-09-19Manufacturing (CMC) · Supplement 5 · priority — Review ↗AP

1996-06-21Type 1 - New Molecular Entity · Original · priority — Review ↗AP

VIEW ON DRUGS@FDA ↗

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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Approval history

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