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Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021478

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NDA 021478 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 five suppliers. Additional details are available on the ZOVIRAX profile page.

The generic ingredient in ZOVIRAX is acyclovir sodium. There are fifty-six 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 021478
Tradename:ZOVIRAX
Applicant:Vib
Ingredient:acyclovir
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 021478
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Medical Subject Heading (MeSH) Categories for 021478
Suppliers and Packaging for NDA: 021478
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOVIRAX acyclovir CREAM;TOPICAL 021478 NDA Valeant Pharmaceuticals North America LLC 0187-0994 N 0187-0994-45
ZOVIRAX acyclovir CREAM;TOPICAL 021478 NDA Rebel Distributors Corp 42254-149 E 42254-149-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength5%
Approval Date:Dec 30, 2002TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Chubb
Harvard Business School
Dow
Cipla
Argus Health
Citi
McKesson
Cantor Fitzgerald

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