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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
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Generated: August 17, 2017

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, 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: 077135

Tradename:
1
Applicant:
1
Ingredient:
1
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 Watson Laboratories, Inc. 0591-3248 0591-3248-19 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3248-19)
VALACYCLOVIR HYDROCHLORIDE
valacyclovir hydrochloride
TABLET;ORAL 077135 ANDA Watson Laboratories, Inc. 0591-3248 0591-3248-21 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3248-21)

Summary for product number 001

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

Summary 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 500+ biopharmaceutical companies globally:

Merck
Mallinckrodt
Johnson and Johnson
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Novartis
Queensland Health
Healthtrust
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Cipla

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