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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090500
Company: APOTEX

Products on ANDA 090500

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090500

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/04/2014	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/07/2024	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
03/23/2021	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090500

VALACYCLOVIR HYDROCHLORIDE

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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