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APO-NILOTINIB DIN 02550903

Status: Marketed
Holder: APOTEX INC
Molecule: NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE)
Available to quote

Health Canada record

Active ingredient(s)NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 200 MG
Dosage formCapsule
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCL01EA03 NILOTINIB
Original market date13-Feb-2025
Current status date13-Feb-2025
SourceHealth Canada DPD

Establishment licence of the holder

Apotex Inc — licence 100375, currently licensed, last inspection rating C (2026-04-21).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE)

DINProductCompanyFormStrengthStatus
02550881APO-NILOTINIBAPOTEX INCCapsuleNILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 150 MGMarketed
02556626REDDY-NILOTINIBDR REDDY'S LABORATORIES LTDCapsuleNILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 50 MGApproved
02556634REDDY-NILOTINIBDR REDDY'S LABORATORIES LTDCapsuleNILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 150 MGMarketed
02556642REDDY-NILOTINIBDR REDDY'S LABORATORIES LTDCapsuleNILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 200 MGMarketed
02368250TASIGNANOVARTIS PHARMACEUTICALS CANADA INCCapsuleNILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 150 MGMarketed
02315874TASIGNANOVARTIS PHARMACEUTICALS CANADA INCCapsuleNILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 200 MGMarketed
02481715TASIGNANOVARTIS PHARMACEUTICALS CANADA INCCapsuleNILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 50 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
346852025-01-14Abbreviated New Drug Submission (ANDS)
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