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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 018603


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NDA 018603 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 018603
Tradename:ZOVIRAX
Applicant:Glaxosmithkline
Ingredient:acyclovir sodium
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 22, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jun 29, 1989TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 30, 1983TE:RLD:Yes

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