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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203511
Company: DR REDDYS

Products on ANDA 203511

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203511

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/04/2014	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203511Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/13/2020	SUPPL-4	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
03/13/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
08/22/2016	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203511

VALGANCICLOVIR HYDROCHLORIDE

TABLET;ORAL; EQ 450MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VALCYTE	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET;ORAL	Prescription	Yes	AB	021304	CHEPLAPHARM
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET;ORAL	Prescription	No	AB	212234	AJANTA PHARMA LTD
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET;ORAL	Prescription	No	AB	204750	AUROBINDO PHARMA LTD
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET;ORAL	Prescription	No	AB	203511	DR REDDYS
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET;ORAL	Prescription	No	AB	206876	DR REDDYS
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET;ORAL	Prescription	No	AB	205166	HETERO LABS LTD V
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET;ORAL	Prescription	No	AB	200790	STRIDES PHARMA

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