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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021481

Marketing Status: Prescription
Active Ingredient: ENFUVIRTIDE
Proprietary Name: FUZEON
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 90MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021481
Product Number: 001
Approval Date: Mar 13, 2003
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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