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Details for New Drug Application (NDA): 020089

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NDA 020089 describes ZOVIRAX, which is a drug marketed by Glaxosmithkline, Valeant Bermuda, Mylan Pharms Inc, 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-four suppliers are listed for this compound. Additional details are available on the acyclovir profile page.

Summary for NDA: 020089

Mylan Pharms Inc
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
TABLET;ORAL 020089 NDA GlaxoSmithKline LLC 0173-0945 0173-0945-55 100 TABLET in 1 BOTTLE (0173-0945-55)
TABLET;ORAL 020089 NDA Prestium Pharma, Inc. 40076-945 40076-945-55 100 TABLET in 1 BOTTLE (40076-945-55)

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 Inc
TABLET;ORAL020089-001Apr 30, 19914,199,574► subscribe
Mylan Pharms Inc
TABLET;ORAL020089-002Apr 30, 19914,199,574► subscribe
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