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Serving leading biopharmaceutical companies globally:

McKinsey
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Deloitte
Cantor Fitzgerald
Farmers Insurance
Cipla
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Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090370

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NDA 090370 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 090370
Tradename:VALACYCLOVIR HYDROCHLORIDE
Applicant:Watson Labs Inc
Ingredient:valacyclovir hydrochloride
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 090370
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 090370
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 090370 ANDA PD-Rx Pharmaceuticals, Inc. 43063-498 43063-498-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-498-10)
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 090370 ANDA PD-Rx Pharmaceuticals, Inc. 43063-498 43063-498-14 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-498-14)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Mar 16, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1GM BASE
Approval Date:Mar 16, 2011TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Baxter
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Julphar
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