Details for New Drug Application (NDA): 211475

NDA 211475 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 211475

Tradename:	VALGANCICLOVIR HYDROCHLORIDE
Applicant:	Hetero Labs Ltd V
Ingredient:	valganciclovir hydrochloride
Patents:	0

Pharmacology for NDA: 211475

Mechanism of Action

DNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 211475

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VALGANCICLOVIR HYDROCHLORIDE	valganciclovir hydrochloride	FOR SOLUTION;ORAL	211475	ANDA	Camber Pharmaceuticals, Inc.	31722-837	31722-837-10	1 BOTTLE, GLASS in 1 CARTON (31722-837-10) / 100 mL in 1 BOTTLE, GLASS
VALGANCICLOVIR HYDROCHLORIDE	valganciclovir hydrochloride	FOR SOLUTION;ORAL	211475	ANDA	American Health Packaging	60687-765	60687-765-13	1 BOTTLE, GLASS in 1 CARTON (60687-765-13) / 100 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SOLUTION;ORAL			Strength	50MG/ML
Approval Date:	Oct 4, 2022	TE:	AB	RLD:	No

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