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Generated: November 18, 2018

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Details for New Drug Application (NDA): 021630

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NDA 021630 describes VFEND, which is a drug marketed by Pf Prism Cv and is included in three NDAs. It is available from two suppliers. There is one patent protecting this drug and three Paragraph IV challenges. 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 021630
Tradename:VFEND
Applicant:Pf Prism Cv
Ingredient:voriconazole
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021630
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VFEND voriconazole FOR SUSPENSION;ORAL 021630 NDA Roerig 0049-3160 0049-3160-44 1 BOTTLE in 1 CARTON (0049-3160-44) > 75 mL in 1 BOTTLE
VFEND voriconazole FOR SUSPENSION;ORAL 021630 NDA Greenstone LLC 59762-0935 59762-0935-3 1 BOTTLE in 1 CARTON (59762-0935-3) > 75 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength200MG/5ML
Approval Date:Dec 19, 2003TE:ABRLD:Yes

Expired US Patents for NDA 021630

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv VFEND voriconazole FOR SUSPENSION;ORAL 021630-001 Dec 19, 2003 ➤ Sign Up ➤ Sign Up
Pf Prism Cv VFEND voriconazole FOR SUSPENSION;ORAL 021630-001 Dec 19, 2003 ➤ Sign Up ➤ Sign Up
Pf Prism Cv VFEND voriconazole FOR SUSPENSION;ORAL 021630-001 Dec 19, 2003 ➤ Sign Up ➤ Sign Up
Pf Prism Cv VFEND voriconazole FOR SUSPENSION;ORAL 021630-001 Dec 19, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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