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Merck
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US Army
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Dow
QuintilesIMS
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Moodys

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077135

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NDA 077135 describes VALACYCLOVIR HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Aurobindo Pharma, Cipla Ltd, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Jubilant Generics, Mylan, Mylan Pharms Inc, Sandoz, Sun Pharm Inds Ltd, Teva Pharms, Watson Labs Inc, West-ward Pharms Int, Wockhardt, and Zydus Pharms Usa Inc, and is included in fifteen NDAs. It is available from forty-eight suppliers. Additional details are available on the VALACYCLOVIR HYDROCHLORIDE profile page.

The generic ingredient in VALACYCLOVIR HYDROCHLORIDE is valacyclovir hydrochloride. There are twenty-three drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the valacyclovir hydrochloride profile page.
Summary for 077135
Tradename:VALACYCLOVIR HYDROCHLORIDE
Applicant:Cipla Ltd
Ingredient:valacyclovir hydrochloride
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 077135
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 077135
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 077135 ANDA Actavis Pharma, Inc. 0591-3248 N 0591-3248-42
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 077135 ANDA Actavis Pharma, Inc. 0591-3248 N 0591-3248-19

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:May 24, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1GM BASE
Approval Date:May 24, 2010TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
US Department of Justice
Deloitte
Express Scripts
Colorcon
McKinsey
Fuji
Citi
AstraZeneca

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