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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 021304

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NDA 021304 describes VALCYTE, which is a drug marketed by Cheplapharm and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the VALCYTE profile page.

The generic ingredient in VALCYTE 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 021304

Tradename:	VALCYTE
Applicant:	Cheplapharm
Ingredient:	valganciclovir hydrochloride
Patents:	0

Pharmacology for NDA: 021304

Mechanism of Action	DNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 021304

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VALCYTE	valganciclovir hydrochloride	TABLET;ORAL	021304	NDA	H2-Pharma, LLC	61269-480	61269-480-60	1 BOTTLE, PLASTIC in 1 CARTON (61269-480-60) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 450MG BASE
Approval Date:	Mar 29, 2001	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021304

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	VALCYTE	valganciclovir hydrochloride	TABLET;ORAL	021304-001	Mar 29, 2001	6,083,953*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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