Application 020487

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VALTREX	VALACYCLOVIR HYDROCHLORIDE	TABLET;ORAL	EQ 500MG BASE	Yes	No
002	VALTREX	VALACYCLOVIR HYDROCHLORIDE	TABLET;ORAL	EQ 1GM BASE	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0173-0565	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0565	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0565	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0565	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0565	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0565	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0565	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0565	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0933	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0933	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0933	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0933	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0933	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0933	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0933	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0933	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
50090-0753	VALTREX	valacyclovir hydrochloride	A-S Medication Solutions	NDA	Current
55289-926	VALTREX	valacyclovir hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
63629-3982	VALTREX	valacyclovir hydrochloride	Bryant Ranch Prepack	NDA	Current
67296-0200	VALTREX	valacyclovir hydrochloride	RedPharm Drug	NDA	Current
67296-0200	VALTREX	valacyclovir hydrochloride	RedPharm Drug	NDA	Current
70518-2039	VALTREX	valacyclovir hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-2039	VALTREX	valacyclovir hydrochloride	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84159	SUPPL	2025-11-13
84154	SUPPL	2025-11-13
67822	SUPPL	2021-06-15
67817	SUPPL	2021-06-15
61240	SUPPL	2019-12-11
61228	SUPPL	2019-12-11
25035	SUPPL	2010-04-22
34702	SUPPL	2010-04-20
25034	SUPPL	2008-09-09
34701	SUPPL	2008-09-03
2594	SUPPL	2008-01-09
12630	SUPPL	2007-12-14
25033	SUPPL	2005-11-30
12629	SUPPL	2005-11-30
41392	SUPPL	2005-06-27
41391	SUPPL	2005-06-27
41390	SUPPL	2005-06-27
20678	SUPPL	2005-06-27
34700	SUPPL	2004-12-08
25032	SUPPL	2004-12-08
66491	ORIG	1900-01-01
66490	ORIG	1900-01-01
53433	ORIG	1900-01-01
53432	ORIG	1900-01-01
53431	ORIG	1900-01-01

Application 020487

Related Records#

Application Products#

NDC Listings For This Application#

Documents#