Viramune

NDA 20636, held by Boehringer Ingelheim. Nevirapine.

As of Nov 14, 2026, NDA 20636 (Viramune), held by Boehringer Ingelheim, was first approved by FDA on Jun 21, 1996, with 35 approved supplements and 0 published complete response letters.

First approved: Jun 21, 1996
Review: Priority
Supplements approved: 35
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 36 submissions below


Jun 24, 2008	Supplement 27Efficacy (new indication or use) · Priority review	Approved	Letter Label
Mar 27, 2002	Supplement 17Efficacy (new indication or use)	Approved	Review Letter
Sep 11, 1998	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
May 20, 1998	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Review
Jun 21, 1996	Original applicationNew molecular entity · Priority review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Viramune200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Nevirapine	DiscontinuedReference drug

All 36 submissions, including labeling and manufacturing supplements


Jun 10, 2022	Supplement 52Labeling · Standard review	Approved	Label Medication Guide Letter
Sep 24, 2018	Supplement 50Labeling · Standard review	Approved	Letter Label
Mar 27, 2017	Supplement 48Labeling · Standard review	Approved	Letter Label
Apr 14, 2016	Supplement 47Manufacturing · Priority review	Approved	None posted
Jan 27, 2014	Supplement 44Labeling · Standard review	Approved	Label Letter
Nov 9, 2012	Supplement 42Labeling · Standard review	Approved	Label Letter
Nov 9, 2011	Supplement 39Labeling · Standard review	Approved	Letter Label
May 6, 2011	Supplement 38REMS	Approved	Letter
Mar 25, 2011	Supplement 37Labeling · Standard review	Approved	Letter Label
Jan 7, 2011	Supplement 36REMS	Approved	Letter Label
Jul 20, 2010	Supplement 35Labeling · Standard review	Approved	Letter Label
Jan 13, 2010	Supplement 32Labeling · Standard review	Approved	Letter Label
Jun 24, 2008	Supplement 27Efficacy (new indication or use) · Priority review	Approved	Letter Label
Aug 16, 2007	Supplement 29Labeling · Standard review	Approved	Letter Label
Apr 13, 2007	Supplement 26Labeling · Standard review	Approved	Label Letter
Feb 24, 2005	Supplement 25Labeling · Standard review	Approved	Review Letter Label
May 24, 2004	Supplement 22Labeling · Standard review	Approved	Label Letter
Dec 22, 2003	Supplement 21Labeling · Standard review	Approved	Label Letter
Jul 29, 2003	Supplement 20Labeling · Standard review	Approved	Letter Label
Dec 31, 2002	Supplement 16Labeling · Standard review	Approved	Letter Label
Dec 18, 2002	Supplement 19Manufacturing · Priority review	Approved	None posted
Mar 27, 2002	Supplement 17Efficacy (new indication or use)	Approved	Review Letter
Feb 23, 2001	Supplement 15Manufacturing · Priority review	Approved	None posted
Nov 6, 2000	Supplement 14Labeling · Standard review	Approved	None posted
Aug 10, 2000	Supplement 13Labeling · Standard review	Approved	None posted
Oct 25, 1999	Supplement 11Labeling · Standard review	Approved	None posted
Aug 5, 1999	Supplement 12Manufacturing · Priority review	Approved	Review
Jun 1, 1999	Supplement 10Manufacturing · Priority review	Approved	None posted
Sep 11, 1998	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
May 20, 1998	Supplement 7Labeling · Standard review	Approved	Review
May 20, 1998	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Review
Jan 16, 1998	Supplement 3Manufacturing · Priority review	Approved	None posted
Nov 21, 1997	Supplement 1Manufacturing · Priority review	Approved	None posted
Sep 24, 1997	Supplement 4Manufacturing · Priority review	Approved	None posted
Sep 19, 1997	Supplement 5Manufacturing · Priority review	Approved	Review
Jun 21, 1996	Original applicationNew molecular entity · Priority review	Approved	Review

Identifiers

Application: NDA 20636
Drugs@FDA: Overview at FDA
Company: Boehringer Ingelheim Pharmaceuticals, Inc.

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters