Application 021304

Type: NDA
Sponsor: HOFFMANN LA ROCHE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VALCYTE	VALGANCICLOVIR HYDROCHLORIDE	TABLET;ORAL	EQ 450MG BASE	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0004-0038	Valcyte	valganciclovir	Genentech, Inc.	NDA	Current
0004-0038	Valcyte	valganciclovir	Genentech, Inc.	NDA	Current
0004-0038	Valcyte	valganciclovir	Genentech, Inc.	NDA	Current
0004-0038	Valcyte	valganciclovir	Genentech, Inc.	NDA	Current
0004-0038	Valcyte	valganciclovir	Genentech, Inc.	NDA	Current
0004-0038	Valcyte	valganciclovir	Genentech, Inc.	NDA	Current
0004-0038	Valcyte	valganciclovir	Genentech, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69787	SUPPL	2021-12-27
69760	SUPPL	2021-12-27
65353	SUPPL	2020-11-27
65335	SUPPL	2020-11-25
65161	SUPPL	2020-11-09
64987	SUPPL	2020-10-23
55102	SUPPL	2018-08-03
55098	SUPPL	2018-08-03
48832	SUPPL	2017-06-26
48825	SUPPL	2017-06-26
36624	SUPPL	2015-04-28
4979	SUPPL	2015-04-24
36623	SUPPL	2013-04-01
27431	SUPPL	2013-04-01
36622	SUPPL	2010-08-10
27430	SUPPL	2010-08-10
24191	SUPPL	2010-05-27
21586	SUPPL	2010-05-27
4978	SUPPL	2009-09-01
15150	SUPPL	2009-08-30
21585	SUPPL	2007-11-19
36621	SUPPL	2006-02-02
4977	SUPPL	2006-02-02
21584	ORIG	2004-04-12
15149	SUPPL	2003-09-25
4976	SUPPL	2003-09-25
15148	ORIG	2001-03-29
4975	ORIG	2001-03-29
52386	ORIG	1900-01-01
52385	ORIG	1900-01-01
52382	ORIG	1900-01-01
52381	ORIG	1900-01-01
52380	ORIG	1900-01-01
51498	ORIG	1900-01-01
51497	ORIG	1900-01-01