Orange Book product · Brand (NDA)
NILOTINIB D-TARTRATE
NILOTINIB D-TARTRATE
Brand (NDA)NDA 218922RX CIPLA
At a glance
Feb 19, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 19, 2025
1 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
NILOTINIB D-TARTRATE
Strength
EQ 200MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 218922
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
