Last Updated: September 24, 2026

Details for New Drug Application (NDA): 021478

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NDA 021478 describes ZOVIRAX, which is a drug marketed by Pharmobedient, 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 two 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

Pharmacology for NDA: 021478

Mechanism of Action	DNA Polymerase Inhibitors

Medical Subject Heading (MeSH) Categories for 021478

Antiviral Agents

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:	RX	Dosage:	CREAM;TOPICAL			Strength	5%
Approval Date:	Dec 30, 2002	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021478

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	ZOVIRAX	acyclovir	CREAM;TOPICAL	021478-001	Dec 30, 2002	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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