Application 020779

Type: NDA
Sponsor: AGOURON PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIRACEPT	NELFINAVIR MESYLATE	TABLET;ORAL	EQ 250MG BASE	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52959-289	VIRACEPT	nelfinavir mesylate	H.J. Harkins Company, Inc.	NDA	Current
55289-477	VIRACEPT	nelfinavir mesylate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
63010-010	VIRACEPT	nelfinavir mesylate	AGOURON	NDA	Current
63010-010	VIRACEPT	nelfinavir mesylate	AGOURON	NDA	Current
63010-010	VIRACEPT	nelfinavir mesylate	AGOURON	NDA	Current
63010-010	VIRACEPT	nelfinavir mesylate	AGOURON	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66879	SUPPL	2021-03-25
66873	SUPPL	2021-03-25
45361	SUPPL	2016-09-22
45303	SUPPL	2016-09-15
35337	SUPPL	2015-04-07
3332	SUPPL	2015-03-31
13410	SUPPL	2013-06-04
3331	SUPPL	2013-05-31
25797	SUPPL	2012-04-11
35335	SUPPL	2012-04-09
25798	SUPPL	2012-02-27
35336	SUPPL	2012-02-24
13409	SUPPL	2011-03-10
25796	SUPPL	2011-02-28
35334	SUPPL	2010-05-03
13408	SUPPL	2010-05-03
25795	SUPPL	2010-04-28
3330	SUPPL	2010-04-28
25794	SUPPL	2008-11-26
35333	SUPPL	2008-02-14
3329	SUPPL	2008-02-14
35332	SUPPL	2007-12-03
41692	SUPPL	2007-08-06
41690	SUPPL	2007-08-06
20941	SUPPL	2007-08-06
20940	SUPPL	2007-08-06
20939	SUPPL	2007-08-06
20938	SUPPL	2007-08-06
25793	SUPPL	2007-01-08
35331	SUPPL	2006-12-28
25792	SUPPL	2005-10-20
35330	SUPPL	2005-09-30
13407	SUPPL	2004-06-07
3328	SUPPL	2004-06-07
13406	SUPPL	2004-04-05
25791	SUPPL	2004-03-24
25790	SUPPL	2003-08-29
35329	SUPPL	2003-08-28
3327	SUPPL	2003-07-30
41691	SUPPL	2003-04-30
25787	SUPPL	2003-04-30
25786	SUPPL	2003-04-30
20937	SUPPL	2003-04-30
35328	SUPPL	2003-04-04
25789	SUPPL	2002-02-05
3326	SUPPL	2002-02-05
25788	SUPPL	2001-04-11
20936	ORIG	1997-03-14