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Last Updated: December 13, 2019

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Details for New Drug Application (NDA): 021481

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NDA 021481 describes FUZEON, which is a drug marketed by Roche and is included in one NDA. It is available from one supplier. Additional details are available on the FUZEON profile page.

The generic ingredient in FUZEON is enfuvirtide. One supplier is listed for this compound. Additional details are available on the enfuvirtide profile page.
Summary for 021481
Tradename:FUZEON
Applicant:Roche
Ingredient:enfuvirtide
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021481
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FUZEON enfuvirtide INJECTABLE;SUBCUTANEOUS 021481 NDA Genentech, Inc. 0004-0381 0004-0381-40 1 KIT in 1 CARTON (0004-0381-40) * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength90MG/VIAL
Approval Date:Mar 13, 2003TE:RLD:Yes

Expired US Patents for NDA 021481

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche FUZEON enfuvirtide INJECTABLE;SUBCUTANEOUS 021481-001 Mar 13, 2003   Start Trial   Start Trial
Roche FUZEON enfuvirtide INJECTABLE;SUBCUTANEOUS 021481-001 Mar 13, 2003   Start Trial   Start Trial
Roche FUZEON enfuvirtide INJECTABLE;SUBCUTANEOUS 021481-001 Mar 13, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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