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Last Updated: December 12, 2025

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

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:	DISCN	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	90MG/VIAL
Approval Date:	Mar 13, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 021481

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

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