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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 213306


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NDA 213306 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 213306
Tradename:VALGANCICLOVIR HYDROCHLORIDE
Applicant:Granules
Ingredient:valganciclovir hydrochloride
Patents:0
Pharmacology for NDA: 213306
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 213306
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride FOR SOLUTION;ORAL 213306 ANDA Granules Pharmaceuticals Inc. 70010-051 70010-051-40 100 mL in 1 BOTTLE (70010-051-40)
VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride FOR SOLUTION;ORAL 213306 ANDA Somerset Therapeutics, LLC 70069-810 70069-810-01 100 mL in 1 BOTTLE (70069-810-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength50MG/ML
Approval Date:Jan 31, 2020TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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