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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Healthtrust
Chinese Patent Office
Dow
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Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204750

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NDA 204750 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 six NDAs. It is available from twelve 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. Thirteen suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.
Summary for 204750
Tradename:VALGANCICLOVIR HYDROCHLORIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:valganciclovir hydrochloride
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 204750
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 204750
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 204750 ANDA McKesson Corporation 63739-357 N 63739-357-33
VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 204750 ANDA Aurobindo Pharma Limited 65862-753 N 65862-753-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 450MG BASE
Approval Date:Mar 31, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
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Daiichi Sankyo
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Merck
Covington
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