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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076588

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NDA 076588 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, and Wockhardt, and is included in fourteen NDAs. It is available from forty-six suppliers. Additional details are available on the VALACYCLOVIR HYDROCHLORIDE profile page.

The generic ingredient in VALACYCLOVIR HYDROCHLORIDE is valacyclovir hydrochloride. There are twenty-two drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the valacyclovir hydrochloride profile page.

Summary for 076588

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

Pharmacology for NDA: 076588

Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 076588

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 076588 ANDA PD-Rx Pharmaceuticals, Inc. 43063-200 43063-200-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-200-10)
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 076588 ANDA Ohm Laboratories Inc. 51660-904 51660-904-30 30 TABLET in 1 BOTTLE (51660-904-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Jan 31, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1GM BASE
Approval Date:Jan 31, 2007TE:ABRLD:No


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