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Last Updated: April 20, 2024

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 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 018604

Tradename:	ZOVIRAX
Applicant:	Bausch
Ingredient:	acyclovir
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 018604

Mechanism of Action	DNA Polymerase Inhibitors

Medical Subject Heading (MeSH) Categories for 018604

Antiviral Agents

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:	RX	Dosage:	OINTMENT;TOPICAL			Strength	5%
Approval Date:	Mar 29, 1982	TE:	AB	RLD:	Yes

Expired US Patents for NDA 018604

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	ZOVIRAX	acyclovir	OINTMENT;TOPICAL	018604-001	Mar 29, 1982	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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