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Generated: January 23, 2019

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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 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-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 018604
Applicant:Valeant Bermuda
Formulation / Manufacturing:see details
Pharmacology for NDA: 018604
Ingredient-typeNucleoside Analog
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 Valeant Pharmaceuticals North America 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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