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

Abbreviated New Drug Application (ANDA): 204750
Company: AUROBINDO PHARMA LTD

Products on ANDA 204750

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 204750

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/31/2016	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
06/27/2022	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
06/27/2022	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
03/12/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
03/12/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
03/12/2020	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204750

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	212876	SOMERSET THERAPS LLC
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET;ORAL	Prescription	No	AB	218027	SPH ZHONGXI PHARM
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET;ORAL	Prescription	No	AB	200790	STRIDES PHARMA INTL

Top