Orange Book product · Brand (NDA)
ORFADIN
NITISINONE
Brand (NDA)NDA 021232TE ABRX SWEDISH ORPHAN
At a glance
Jan 18, 2002
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 18, 2002
24 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
NITISINONE
Strength
2MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 021232
Product number
001
Marketing status
RX
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.
