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Details for New Drug Application (NDA): 019909

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NDA 019909 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-one suppliers are listed for this compound. Additional details are available on the acyclovir profile page.

Summary for NDA: 019909

Delcor Asset
Therapeutic Class:Antivirals

Pharmacology for NDA: 019909

Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 019909

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUSPENSION;ORAL 019909 NDA Prestium Pharma, Inc. 40076-953 40076-953-96 473 mL in 1 BOTTLE (40076-953-96)
SUSPENSION;ORAL 019909 NDA AUTHORIZED GENERIC Renaissance Pharma, Inc. 40085-842 40085-842-96 473 mL in 1 BOTTLE (40085-842-96)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength200MG/5ML
Approval Date:Dec 22, 1989TE:ABRLD:Yes

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