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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 Glaxosmithkline, Valeant Bermuda, Delcor Asset, Delcor Asset Corp, and VIB, and is included in six NDAs. It is available from seven suppliers. Additional details are available on the ZOVIRAX profile page.

The generic ingredient in ZOVIRAX is acyclovir. There are fifty-five drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the acyclovir profile page.

Summary for NDA: 018604

Tradename:
ZOVIRAX
Applicant:
Valeant Bermuda
Ingredient:
acyclovir
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 018604

Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors

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

Summary for product number 001

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

Expired Orange Book Patents for NDA: 018604

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Bermuda
ZOVIRAX
acyclovir
OINTMENT;TOPICAL018604-001Mar 29, 19824,199,574► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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