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UBS
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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018828

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NDA 018828 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 five 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. Seven suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 018828
Tradename:ZOVIRAX
Applicant:Mylan Pharms Inc
Ingredient:acyclovir
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 018828
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Medical Subject Heading (MeSH) Categories for 018828
Suppliers and Packaging for NDA: 018828
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOVIRAX acyclovir CAPSULE;ORAL 018828 NDA Prestium Pharma, Inc. 40076-991 N 40076-991-55
ZOVIRAX acyclovir CAPSULE;ORAL 018828 NDA REMEDYREPACK INC. 61786-186 N 61786-186-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Jan 25, 1985TE:ABRLD:Yes

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Argus Health
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US Department of Justice
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