Orange Book product · Generic (ANDA)
NILOTINIB HYDROCHLORIDE
NILOTINIB HYDROCHLORIDE
Generic (ANDA)ANDA 218544TE ABRX MSN
At a glance
Nov 19, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 19, 2025
7 mo ago
Today
Pharmaceutical detail
Active ingredient
NILOTINIB HYDROCHLORIDE
Strength
EQ 50MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 218544
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of NILOTINIB HYDROCHLORIDE
- 2018TASIGNABrand (NDA)
NDA 022068 · NOVARTIS
- 2025NILOTINIB HYDROCHLORIDEGeneric (ANDA)
ANDA 218532 · TORRENT
- 2025NILOTINIB HYDROCHLORIDEGeneric (ANDA)
ANDA 218350 · DR REDDYS
- 2025NILOTINIB HYDROCHLORIDEGeneric (ANDA)
ANDA 209651 · HETERO LABS LTD V
- 2024NILOTINIB HYDROCHLORIDEGeneric (ANDA)
ANDA 203640 · APOTEX
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.
