Application 020933

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIRAMUNE	NEVIRAPINE	SUSPENSION;ORAL	50MG/5ML	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0047	Viramune	nevirapine	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0047	Viramune	nevirapine	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0047	Viramune	nevirapine	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0047	Viramune	nevirapine	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0047	Viramune	nevirapine	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0047	Viramune	nevirapine	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79167	SUPPL	2024-07-24
79165	SUPPL	2024-07-24
79149	SUPPL	2024-07-23
71317	SUPPL	2022-06-15
71316	SUPPL	2022-06-15
71285	SUPPL	2022-06-13
55743	SUPPL	2018-10-01
55614	SUPPL	2018-09-25
55612	SUPPL	2018-09-25
47767	SUPPL	2017-03-29
47737	SUPPL	2017-03-28
35662	SUPPL	2014-01-28
26225	SUPPL	2014-01-28
13766	SUPPL	2012-11-15
26224	SUPPL	2012-11-13
26223	SUPPL	2011-11-14
13765	SUPPL	2011-11-10
26222	SUPPL	2011-05-10
3783	SUPPL	2011-03-31
13764	SUPPL	2011-03-28
26221	SUPPL	2011-01-14
35661	SUPPL	2011-01-10
3782	SUPPL	2010-07-23
35660	SUPPL	2010-07-22
3781	SUPPL	2010-01-26
13763	SUPPL	2010-01-20
3779	SUPPL	2008-06-30
13761	SUPPL	2008-06-26
13762	SUPPL	2007-08-17
3780	SUPPL	2007-08-17
21282	SUPPL	2007-07-27
13760	SUPPL	2007-04-20
3778	SUPPL	2007-04-20
41820	SUPPL	2005-04-27
35659	SUPPL	2005-03-02
3777	SUPPL	2005-03-02
26219	SUPPL	2004-06-30
13756	ORIG	2004-06-30
3775	SUPPL	2004-06-30
3774	ORIG	2004-06-30
41819	ORIG	2004-02-09
13759	SUPPL	2003-12-29
26220	SUPPL	2003-12-23
13758	SUPPL	2003-08-06
13757	SUPPL	2003-04-04
3776	SUPPL	2002-03-27