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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 021478


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NDA 021478 describes ZOVIRAX, which is a drug marketed by Mylan, Bausch, and Glaxosmithkline, and is included in six NDAs. It is available from three 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. Eight suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 021478
Tradename:ZOVIRAX
Applicant:Bausch
Ingredient:acyclovir
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021478
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 AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0093-3630 0093-3630-20 1 TUBE in 1 CARTON (0093-3630-20) / 5 g in 1 TUBE
ZOVIRAX acyclovir CREAM;TOPICAL 021478 NDA Bausch Health US, LLC 0187-0994 0187-0994-45 1 TUBE in 1 CARTON (0187-0994-45) / 5 g in 1 TUBE

Profile for product number 001

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

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