Details for New Drug Application (NDA): 022257

NDA 022257 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. Twenty-one suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.

Summary for 022257

Tradename:	VALCYTE
Applicant:	Cheplapharm
Ingredient:	valganciclovir hydrochloride
Patents:	2

Pharmacology for NDA: 022257

Mechanism of Action

DNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 022257

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VALCYTE	valganciclovir hydrochloride	FOR SOLUTION;ORAL	022257	NDA	H2-Pharma, LLC	61269-485	61269-485-10	1 BOTTLE, GLASS in 1 CARTON (61269-485-10) / 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:	Aug 28, 2009	TE:	AB	RLD:	Yes
Patent:	8,889,109	Patent Expiration:	Dec 11, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	9,642,911	Patent Expiration:	Dec 11, 2027	Product Flag?	Y	Substance Flag?		Delist Request?

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