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Daiichi Sankyo
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US Army
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Generated: May 28, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078518

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NDA 078518 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 078518
Tradename:VALACYCLOVIR HYDROCHLORIDE
Applicant:Mylan Pharms Inc
Ingredient:valacyclovir hydrochloride
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 078518
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 078518
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 078518 ANDA Mylan Pharmaceuticals Inc. 0378-4275 N 0378-4275-05
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 078518 ANDA Mylan Pharmaceuticals Inc. 0378-4275 N 0378-4275-77

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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Queensland Health
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