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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020089

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NDA 020089 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-five drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.

Summary for 020089

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 020089

Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 020089

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOVIRAX acyclovir TABLET;ORAL 020089 NDA Prestium Pharma, Inc. 40076-945 40076-945-55 100 TABLET in 1 BOTTLE (40076-945-55)
ZOVIRAX acyclovir TABLET;ORAL 020089 NDA Prestium Pharma, Inc. 40076-949 40076-949-55 100 TABLET in 1 BOTTLE (40076-949-55)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Apr 30, 1991TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Apr 30, 1991TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 020089

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Pharms IncZOVIRAXacyclovirTABLET;ORAL020089-001Apr 30, 1991► Subscribe► Subscribe
Mylan Pharms IncZOVIRAXacyclovirTABLET;ORAL020089-002Apr 30, 1991► Subscribe► Subscribe
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