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Generated: November 19, 2018

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Details for New Drug Application (NDA): 021304

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NDA 021304 describes VALCYTE, which is a drug marketed by Hoffmann La Roche 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. Fourteen suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.
Summary for 021304
Tradename:VALCYTE
Applicant:Hoffmann La Roche
Ingredient:valganciclovir hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021304
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA 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 Genentech, Inc. 0004-0038 0004-0038-22 1 BOTTLE, PLASTIC in 1 CARTON (0004-0038-22) > 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
VALCYTE valganciclovir hydrochloride TABLET;ORAL 021304 NDA Genentech, Inc. 0004-0038 0004-0038-86 1 BOTTLE in 1 CARTON (0004-0038-86) > 60 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 450MG BASE
Approval Date:Mar 29, 2001TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Apr 23, 2018
Regulatory Exclusivity Use:EXTENDED THE DURATION OF THE DOSING REGIMEN FROM 100 DAYS TO 200 DAYS POST-TRANSPLANTATION FOR THE PREVENTION OF CMV DISEASE IN PEDIATRIC KIDNEY TRANSPLANT
Regulatory Exclusivity Expiration:Apr 23, 2018
Regulatory Exclusivity Use:NEW PATIENT POPULATION

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