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Generated: August 19, 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, Jubilant Generics, Dr Reddys Labs Ltd, Wockhardt, Mylan Pharms Inc, Cipla Ltd, Hetero Labs Ltd V, Teva Pharms, West-ward Pharms Int, Mylan, Watson Labs Inc, Sandoz, Aurobindo Pharma, and Sun Pharm Inds Ltd, 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-eight suppliers are listed for this compound. Additional details are available on the valacyclovir hydrochloride profile page.

Summary for NDA: 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 51660-904-03 10 TABLET in 1 BOTTLE (51660-904-03)

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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