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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203511

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NDA 203511 describes VALGANCICLOVIR HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Endo Pharms Inc, and Hetero Labs Ltd V, and is included in five NDAs. It is available from nine suppliers. Additional details are available on the VALGANCICLOVIR HYDROCHLORIDE profile page.

The generic ingredient in VALGANCICLOVIR HYDROCHLORIDE is valganciclovir hydrochloride. There are fifteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.

Summary for 203511

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 203511

Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 203511

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 203511 ANDA Dr. Reddy's Laboratories Limited 55111-762 55111-762-78 10 BLISTER PACK in 1 CARTON (55111-762-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-762-79)
VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 203511 ANDA Dr. Reddy's Laboratories Limited 55111-762 55111-762-60 60 TABLET, FILM COATED in 1 BOTTLE (55111-762-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 450MG BASE
Approval Date:Nov 4, 2014TE:ABRLD:No


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