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Serving hundreds of leading biopharmaceutical companies globally:

US Army
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Farmers Insurance
Federal Trade Commission
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Generated: March 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020089

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NDA 020089 describes ZOVIRAX, which is a drug marketed by Mylan Pharms Inc, VIB, Glaxosmithkline, and Valeant Bermuda, and is included in six NDAs. It is available from six suppliers. Additional details are available on the ZOVIRAX profile page.

The generic ingredient in ZOVIRAX is acyclovir sodium. There are fifty-five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 020089
Applicant:Mylan Pharms Inc
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 020089
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Medical Subject Heading (MeSH) Categories for 020089
Suppliers and Packaging for NDA: 020089
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOVIRAX acyclovir TABLET;ORAL 020089 NDA Prestium Pharma, Inc. 40076-945 N 40076-945-55
ZOVIRAX acyclovir TABLET;ORAL 020089 NDA Prestium Pharma, Inc. 40076-949 N 40076-949-55

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Apr 30, 1991TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Apr 30, 1991TE:ABRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Queensland Health
Daiichi Sankyo
Johnson and Johnson
US Army

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