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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 209672

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NDA 209672 describes VALGANCICLOVIR HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Appco, Aurobindo Pharma, Granules, Hetero Labs Ltd V, MSN, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Pharmobedient, Somerset Theraps Llc, Sph Zhongxi Pharm, and Strides Pharma Intl, and is included in seventeen NDAs. It is available from eighteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.

Summary for 209672

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 450MG BASE
Approval Date:	Nov 9, 2018	TE:		RLD:	No

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