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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021267


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NDA 021267 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 021267
Tradename:VFEND
Applicant:Pf Prism Cv
Ingredient:voriconazole
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021267
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VFEND voriconazole INJECTABLE;INTRAVENOUS 021267 NDA Roerig 0049-3190 0049-3190-28 1 VIAL, SINGLE-DOSE in 1 CARTON (0049-3190-28) > 20 mL in 1 VIAL, SINGLE-DOSE
VFEND voriconazole INJECTABLE;INTRAVENOUS 021267 NDA Roerig 0049-3190 0049-3190-01 1 VIAL, SINGLE-USE in 1 CARTON (0049-3190-01) > 20 mL in 1 VIAL, SINGLE-USE
Paragraph IV (Patent) Challenges for 021267
Tradename Dosage Ingredient NDA Submissiondate
VFEND INJECTABLE;INTRAVENOUS voriconazole 021267 2008-09-12

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength200MG/VIAL
Approval Date:May 24, 2002TE:APRLD:Yes
Regulatory Exclusivity Expiration:Jan 29, 2022
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Expired US Patents for NDA 021267

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv VFEND voriconazole INJECTABLE;INTRAVENOUS 021267-001 May 24, 2002   Start Trial   Start Trial
Pf Prism Cv VFEND voriconazole INJECTABLE;INTRAVENOUS 021267-001 May 24, 2002   Start Trial   Start Trial
Pf Prism Cv VFEND voriconazole INJECTABLE;INTRAVENOUS 021267-001 May 24, 2002   Start Trial   Start Trial
Pf Prism Cv VFEND voriconazole INJECTABLE;INTRAVENOUS 021267-001 May 24, 2002   Start Trial   Start Trial
Pf Prism Cv VFEND voriconazole INJECTABLE;INTRAVENOUS 021267-001 May 24, 2002   Start Trial   Start Trial
Pf Prism Cv VFEND voriconazole INJECTABLE;INTRAVENOUS 021267-001 May 24, 2002   Start Trial   Start Trial
Pf Prism Cv VFEND voriconazole INJECTABLE;INTRAVENOUS 021267-001 May 24, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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