An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020487
Company: GLAXOSMITHKLINE

Products on NDA 020487

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VALTREX	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET;ORAL	Prescription	AB	Yes	No
VALTREX	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020487

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/23/1995	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/14/2021	SUPPL-22	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020487s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020487Orig1s022ltr.pdf
12/10/2019	SUPPL-20	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020487s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020487Orig1s020ltr.pdf
04/19/2010	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020487s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020487s016ltr.pdf
09/02/2008	SUPPL-14	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020487s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020487s014ltr.pdf
12/11/2007	SUPPL-13	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020487s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020487s013ltr.pdf
11/23/2005	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020487s007rel2_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020487s007rel2_ltr.pdf
12/03/2004	SUPPL-5	Labeling	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20487s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20487s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-487s005_ValtrexTOC.cfm
01/13/1997	SUPPL-4	Labeling	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-487s004_ValtrexTOC.cfm
08/09/1996	SUPPL-3	Manufacturing (CMC)-Control	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/20-487s003_ValtrexTOC.cfm
09/08/1995	SUPPL-2	Manufacturing (CMC)-Control	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-487s002_ValtrexTOC.cfm

Labels for NDA 020487

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/14/2021	SUPPL-22	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020487s022lbl.pdf
06/14/2021	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020487s022lbl.pdf
12/10/2019	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020487s020lbl.pdf
12/10/2019	SUPPL-20	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020487s020lbl.pdf
04/19/2010	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020487s016lbl.pdf
09/02/2008	SUPPL-14	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020487s014lbl.pdf
12/11/2007	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020487s013lbl.pdf
11/23/2005	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020487s007rel2_lbl.pdf
12/03/2004	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20487s005lbl.pdf

Therapeutic Equivalents for NDA 020487

VALTREX

TABLET;ORAL; EQ 500MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	090500	APOTEX
VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	090682	AUROBINDO PHARMA
VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	090216	CHARTWELL RX
VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	079012	GRAVITI PHARMS
VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	203047	HETERO LABS LTD V
VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	201506	JUBILANT GENERICS
VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	078518	MYLAN PHARMS INC
VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	076588	SUN PHARM INDS LTD
VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	209553	YILING
VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	079137	ZYDUS LIFESCIENCES
VALTREX	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET;ORAL	Prescription	Yes	AB	020487	GLAXOSMITHKLINE

TABLET;ORAL; EQ 1GM BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET;ORAL	Prescription	No	AB	090500	APOTEX
VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET;ORAL	Prescription	No	AB	090682	AUROBINDO PHARMA
VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET;ORAL	Prescription	No	AB	090216	CHARTWELL RX
VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET;ORAL	Prescription	No	AB	079012	GRAVITI PHARMS
VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET;ORAL	Prescription	No	AB	203047	HETERO LABS LTD V
VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET;ORAL	Prescription	No	AB	201506	JUBILANT GENERICS
VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET;ORAL	Prescription	No	AB	078518	MYLAN PHARMS INC
VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET;ORAL	Prescription	No	AB	076588	SUN PHARM INDS LTD
VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET;ORAL	Prescription	No	AB	209553	YILING
VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET;ORAL	Prescription	No	AB	079137	ZYDUS LIFESCIENCES
VALTREX	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET;ORAL	Prescription	Yes	AB	020487	GLAXOSMITHKLINE

Top