Orange Book product · Brand (NDA)
FUZEON
ENFUVIRTIDE
Brand (NDA)NDA 021481DISCN ROCHE
At a glance
Mar 13, 2003
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 13, 2003
23 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
ENFUVIRTIDE
Strength
90MG/VIAL
Dosage form
INJECTABLE
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 021481
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
