Application 021814

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	APTIVUS	TIPRANAVIR	CAPSULE;ORAL	250MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0003	Aptivus	tipranavir	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0003	Aptivus	tipranavir	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0003	Aptivus	tipranavir	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0003	Aptivus	tipranavir	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0003	Aptivus	tipranavir	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78060	SUPPL	2024-04-04
78057	SUPPL	2024-04-03
63652	SUPPL	2020-06-22
63633	SUPPL	2020-06-19
54857	SUPPL	2018-07-06
54716	SUPPL	2018-06-28
45375	SUPPL	2016-09-23
45343	SUPPL	2016-09-20
37697	SUPPL	2015-04-07
6243	SUPPL	2015-04-01
37696	SUPPL	2014-04-08
28646	SUPPL	2014-04-08
28645	SUPPL	2012-02-27
37695	SUPPL	2012-02-22
6242	SUPPL	2011-04-07
16416	SUPPL	2011-04-06
6241	SUPPL	2010-09-07
16415	SUPPL	2010-08-16
24218	SUPPL	2010-05-12
21827	SUPPL	2010-05-12
37694	SUPPL	2010-05-07
28644	SUPPL	2010-05-03
37693	SUPPL	2009-06-24
6240	SUPPL	2009-06-24
37692	SUPPL	2008-06-26
28643	SUPPL	2008-06-26
28642	SUPPL	2007-10-10
16414	SUPPL	2007-10-10
6239	SUPPL	2007-05-29
28641	SUPPL	2006-08-18
28640	SUPPL	2006-08-18
37691	SUPPL	2006-08-14
16413	SUPPL	2006-08-14
21826	ORIG	2005-09-02
28639	ORIG	2005-06-24
37690	ORIG	2005-06-23
53417	ORIG	1900-01-01
53416	ORIG	1900-01-01
53415	ORIG	1900-01-01