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Drugs@FDA: FDA-Approved Drugs

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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-Package Insert, Labeling-Patient 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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020487s022lbl.pdf
06/14/2021	SUPPL-22	Labeling-Patient 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	079012	ADAPTIS
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	077135	CIPLA
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	077478	SANDOZ
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	079012	ADAPTIS
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	077135	CIPLA
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	077478	SANDOZ
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

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