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NUCYNTA EXTENDED-RELEASE DIN 02415607

Status: Marketed
Holder: KNIGHT THERAPEUTICS INC.
Molecule: TAPENTADOL (TAPENTADOL HYDROCHLORIDE)

Health Canada record

Active ingredient(s)TAPENTADOL (TAPENTADOL HYDROCHLORIDE) 200 MG
Dosage formTablet (Extended-Release)
RouteOral
ScheduleNARCOTICS (CDSA I)
ClassHuman
ATCN02AX06 TAPENTADOL
Original market date16-Apr-2014
Current status date05-Mar-2026
SourceHealth Canada DPD

Establishment licence of the holder

Knight Therapeutics Inc. — licence 3-002350, currently licensed, last inspection rating C (2025-11-05).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing TAPENTADOL (TAPENTADOL HYDROCHLORIDE)

DINProductCompanyFormStrengthStatus
02471965APO-TAPENTADOLAPOTEX INCTablet (Immediate-Release)TAPENTADOL (TAPENTADOL HYDROCHLORIDE) 50 MGApproved
02471981APO-TAPENTADOLAPOTEX INCTablet (Immediate-Release)TAPENTADOL (TAPENTADOL HYDROCHLORIDE) 100 MGApproved
02471973APO-TAPENTADOLAPOTEX INCTablet (Immediate-Release)TAPENTADOL (TAPENTADOL HYDROCHLORIDE) 75 MGApproved
02415593NUCYNTA EXTENDED-RELEASEKNIGHT THERAPEUTICS INC.Tablet (Extended-Release)TAPENTADOL (TAPENTADOL HYDROCHLORIDE) 150 MGMarketed
02415615NUCYNTA EXTENDED-RELEASEKNIGHT THERAPEUTICS INC.Tablet (Extended-Release)TAPENTADOL (TAPENTADOL HYDROCHLORIDE) 250 MGMarketed
02415577NUCYNTA EXTENDED-RELEASEKNIGHT THERAPEUTICS INC.Tablet (Extended-Release)TAPENTADOL (TAPENTADOL HYDROCHLORIDE) 50 MGMarketed
02415585NUCYNTA EXTENDED-RELEASEKNIGHT THERAPEUTICS INC.Tablet (Extended-Release)TAPENTADOL (TAPENTADOL HYDROCHLORIDE) 100 MGMarketed
02378299NUCYNTA IRKNIGHT THERAPEUTICS INC.Tablet (Immediate-Release)TAPENTADOL (TAPENTADOL HYDROCHLORIDE) 100 MGMarketed
02378272NUCYNTA IRKNIGHT THERAPEUTICS INC.Tablet (Immediate-Release)TAPENTADOL (TAPENTADOL HYDROCHLORIDE) 50 MGMarketed
02378280NUCYNTA IRKNIGHT THERAPEUTICS INC.Tablet (Immediate-Release)TAPENTADOL (TAPENTADOL HYDROCHLORIDE) 75 MGMarketed
02360373NUCYNTA CRJANSSEN INCTablet (Extended-Release)TAPENTADOL (TAPENTADOL HYDROCHLORIDE) 50 MGCancelled Post Market
02360438NUCYNTA CRJANSSEN INCTablet (Extended-Release)TAPENTADOL (TAPENTADOL HYDROCHLORIDE) 250 MGCancelled Post Market
02360411NUCYNTA CRJANSSEN INCTablet (Extended-Release)TAPENTADOL (TAPENTADOL HYDROCHLORIDE) 200 MGCancelled Post Market
02360403NUCYNTA CRJANSSEN INCTablet (Extended-Release)TAPENTADOL (TAPENTADOL HYDROCHLORIDE) 150 MGCancelled Post Market
02360381NUCYNTA CRJANSSEN INCTablet (Extended-Release)TAPENTADOL (TAPENTADOL HYDROCHLORIDE) 100 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
370472026-03-05New Drug Submission (NDS)Administrative: Change in product ownership
148602013-10-31Supplement to a New Drug Submission (SNDS)NEW EXTENDED RELEASE FORMULATION AND THE ADDITION OF ALCOHOL INTERACTION DATA
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