Last Updated: June 25, 2026

Details for New Drug Application (NDA): 205151

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NDA 205151 describes VALGANCICLOVIR HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Appco, Aurobindo Pharma, Granules, Hetero Labs Ltd V, Micro Labs, MSN, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Pharmobedient, Somerset Theraps Llc, Sph Zhongxi Pharm, and Strides Pharma Intl, and is included in eighteen NDAs. It is available from twenty suppliers. Additional details are available on the VALGANCICLOVIR HYDROCHLORIDE profile page.

The generic ingredient in VALGANCICLOVIR HYDROCHLORIDE is valganciclovir hydrochloride. There are seventeen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.

Summary for 205151

Tradename:	VALGANCICLOVIR HYDROCHLORIDE
Applicant:	Pharmobedient
Ingredient:	valganciclovir hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 450MG BASE
Approval Date:	Mar 3, 2021	TE:		RLD:	No

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