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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212234
Company: AJANTA PHARMA LTD

Products on ANDA 212234

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 212234

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/26/2019	ORIG-1	Approval		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
08/22/2022	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
06/04/2021	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
06/04/2021	SUPPL-7	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 212234

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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