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Generated: September 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021478

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NDA 021478 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 six 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-six suppliers are listed for this compound. Additional details are available on the acyclovir profile page.

Summary for NDA: 021478

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 021478

Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 021478

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOVIRAX
acyclovir
CREAM;TOPICAL 021478 NDA Valeant Pharmaceuticals North America LLC 0187-0994 0187-0994-45 1 TUBE in 1 CARTON (0187-0994-45) > 5 g in 1 TUBE
ZOVIRAX
acyclovir
CREAM;TOPICAL 021478 NDA Rebel Distributors Corp 42254-149 42254-149-05 5 g in 1 TUBE (42254-149-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength5%
Approval Date:Dec 30, 2002TE:RLD:Yes

Expired Orange Book Patents for NDA: 021478

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Vib
ZOVIRAX
acyclovir
CREAM;TOPICAL021478-001Dec 30, 2002► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

UBS
Daiichi Sankyo
Deloitte
QuintilesIMS
Healthtrust
AstraZeneca
Moodys
Colorcon
Citi
Fuji

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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