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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, 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-two suppliers are listed for this compound. Additional details are available on the acyclovir profile page.

Summary for NDA: 020089

Tradename:
ZOVIRAX
Applicant:
Delcor Asset Corp
Ingredient:
acyclovir
Patents:0
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
ZOVIRAX
acyclovir
TABLET;ORAL 020089 NDA GlaxoSmithKline LLC 0173-0945 0173-0945-55 100 TABLET in 1 BOTTLE (0173-0945-55)
ZOVIRAX
acyclovir
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:No

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
Delcor Asset Corp
ZOVIRAX
acyclovir
TABLET;ORAL020089-001Apr 30, 19914,199,574► subscribe
Delcor Asset Corp
ZOVIRAX
acyclovir
TABLET;ORAL020089-002Apr 30, 19914,199,574► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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