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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 three suppliers. There are two patents 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 eleven drug master file entries for this compound. Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the voriconazole profile page.

Summary for NDA: 021630

Tradename:
VFEND
Applicant:
Pf Prism Cv
Ingredient:
voriconazole
Patents:1
Therapeutic Class:Antifungals
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength200MG/5ML
Approval Date:Dec 19, 2003TE:ABRLD:Yes
Patent:5,567,817Patent Expiration:May 24, 2016Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF FUNGAL INFECTIONS

Expired Orange Book Patents for NDA: 021630

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv
VFEND
voriconazole
FOR SUSPENSION;ORAL021630-001Dec 19, 20035,116,844► subscribe
Pf Prism Cv
VFEND
voriconazole
FOR SUSPENSION;ORAL021630-001Dec 19, 20035,773,443► subscribe
Pf Prism Cv
VFEND
voriconazole
FOR SUSPENSION;ORAL021630-001Dec 19, 20035,567,817► 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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