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Last Updated: July 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021266


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NDA 021266 describes VFEND, which is a drug marketed by Pf Prism Cv and is included in three NDAs. It is available from two suppliers. Additional details are available on the VFEND profile page.

The generic ingredient in VFEND is voriconazole. There are fourteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the voriconazole profile page.
Summary for 021266
Tradename:VFEND
Applicant:Pf Prism Cv
Ingredient:voriconazole
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021266
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VFEND voriconazole TABLET;ORAL 021266 NDA Roerig 0049-3170 0049-3170-30 30 TABLET, FILM COATED in 1 BOTTLE (0049-3170-30)
VFEND voriconazole TABLET;ORAL 021266 NDA Roerig 0049-3180 0049-3180-30 30 TABLET, FILM COATED in 1 BOTTLE (0049-3180-30)
Paragraph IV (Patent) Challenges for 021266
Tradename Dosage Ingredient NDA Submissiondate
VFEND TABLET;ORAL voriconazole 021266 2008-04-14

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:May 24, 2002TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jan 29, 2022
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:May 24, 2002TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jan 29, 2022
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Expired US Patents for NDA 021266

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv VFEND voriconazole TABLET;ORAL 021266-002 May 24, 2002   Start Trial   Start Trial
Pf Prism Cv VFEND voriconazole TABLET;ORAL 021266-001 May 24, 2002   Start Trial   Start Trial
Pf Prism Cv VFEND voriconazole TABLET;ORAL 021266-002 May 24, 2002   Start Trial   Start Trial
Pf Prism Cv VFEND voriconazole TABLET;ORAL 021266-001 May 24, 2002   Start Trial   Start Trial
Pf Prism Cv VFEND voriconazole TABLET;ORAL 021266-001 May 24, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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