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Last Updated: August 10, 2022

Details for New Drug Application (NDA): 019909

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NDA 019909 describes ZOVIRAX, which is a drug marketed by Mylan, Bausch, and Glaxosmithkline, and is included in six NDAs. It is available from four 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. Five suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 019909
Formulation / Manufacturing:see details
Pharmacology for NDA: 019909
Mechanism of ActionDNA Polymerase Inhibitors
Medical Subject Heading (MeSH) Categories for 019909
Suppliers and Packaging for NDA: 019909
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOVIRAX acyclovir SUSPENSION;ORAL 019909 NDA AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 0378-8712 0378-8712-73 473 mL in 1 BOTTLE (0378-8712-73)
ZOVIRAX acyclovir SUSPENSION;ORAL 019909 NDA Mylan Pharmaceuticals Inc. 0378-9735 0378-9735-73 473 mL in 1 BOTTLE (0378-9735-73)

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
Johnson and Johnson

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