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Last Updated: July 4, 2020

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Details for New Drug Application (NDA): 018604


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NDA 018604 describes ZOVIRAX, which is a drug marketed by Mylan, Bausch, and Glaxosmithkline, 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. Five suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 018604
Tradename:ZOVIRAX
Applicant:Bausch
Ingredient:acyclovir
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018604
Mechanism of ActionDNA Polymerase Inhibitors
Medical Subject Heading (MeSH) Categories for 018604
Suppliers and Packaging for NDA: 018604
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOVIRAX acyclovir OINTMENT;TOPICAL 018604 NDA Bausch Health US LLC 0187-0993 0187-0993-95 1 TUBE in 1 CARTON (0187-0993-95) > 30 g in 1 TUBE
ZOVIRAX acyclovir OINTMENT;TOPICAL 018604 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0591-1159 0591-1159-30 1 TUBE in 1 CARTON (0591-1159-30) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength5%
Approval Date:Mar 29, 1982TE:ABRLD:Yes

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