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TEVA-BUPRENORPHINE/NALOXONE DIN 02453908

Status: Marketed
Holder: TEVA CANADA LIMITED
Molecule: BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE)

Health Canada record

Active ingredient(s)BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 2 MG; NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) 0.5 MG
Dosage formTablet
RouteSublingual
ScheduleNARCOTICS (CDSA I)
ClassHuman
ATCN07BC51 BUPRENORPHINE, COMBINATIONS
Original market date28-Sep-2017
Current status date22-Mar-2021
SourceHealth Canada DPD

Establishment licence of the holder

Teva Canada Limited — licence 101810, currently licensed, last inspection rating C (2025-03-04).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE)

DINProductCompanyFormStrengthStatus
02526301BUPAQVETVIVA RICHTER GMBHSolutionBUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 0.3 MGMarketed
02531143BUPRENOLCHAMPION ALSTOE ANIMAL HEALTH INC.SolutionBUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 0.3 MGMarketed
02542536BUPRIXAZOETIS CANADA INCSolutionBUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 0.3 MGApproved
02424851PMS-BUPRENORPHINE-NALOXONEPHARMASCIENCE INCTabletBUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 2 MG; NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) 0.5 MGMarketed
02424878PMS-BUPRENORPHINE-NALOXONEPHARMASCIENCE INCTabletBUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 8 MG; NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) 2 MGMarketed
02295695SUBOXONEINDIVIOR UK LIMITEDTabletBUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 2 MG; NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) 0.5 MGMarketed
02295709SUBOXONEINDIVIOR UK LIMITEDTabletBUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 8 MG; NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) 2 MGMarketed
02468085SUBOXONEINDIVIOR UK LIMITEDTabletBUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 12 MG; NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) 3 MGMarketed
02468093SUBOXONEINDIVIOR UK LIMITEDTabletBUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 16 MG; NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) 4 MGMarketed
02502313SUBOXONEINDIVIOR UK LIMITEDFilm (Soluble)BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 2 MG; NALOXONE (NALOXONE HYDROCHLORIDE) 0.5 MGMarketed
02502321SUBOXONEINDIVIOR UK LIMITEDFilm (Soluble)BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 4 MG; NALOXONE (NALOXONE HYDROCHLORIDE) 1 MGMarketed
02502348SUBOXONEINDIVIOR UK LIMITEDFilm (Soluble)BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 8 MG; NALOXONE (NALOXONE HYDROCHLORIDE) 2 MGMarketed
02502356SUBOXONEINDIVIOR UK LIMITEDFilm (Soluble)BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 12 MG; NALOXONE (NALOXONE HYDROCHLORIDE) 3 MGMarketed
02517183TARO-BUPRENORPHINE/NALOXONETARO PHARMACEUTICALS INCTabletBUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 8 MG; NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) 2 MGApproved
02517175TARO-BUPRENORPHINE/NALOXONETARO PHARMACEUTICALS INCTabletBUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 2 MG; NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) 0.5 MGApproved
02453916TEVA-BUPRENORPHINE/NALOXONETEVA CANADA LIMITEDTabletBUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 8 MG; NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) 2 MGMarketed
02342510VETERGESIC MULTIDOSECEVA ANIMAL HEALTH INCSolutionBUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 0.3 MGMarketed
02465280BELBUCAPURDUE PHARMAFilm (Soluble)BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 750 MCGCancelled Pre Market
02465299BELBUCAPURDUE PHARMAFilm (Soluble)BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 900 MCGCancelled Pre Market
02465264BELBUCAPURDUE PHARMAFilm (Soluble)BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 450 MCGCancelled Post Market
02465272BELBUCAPURDUE PHARMAFilm (Soluble)BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 600 MCGCancelled Pre Market
02465221BELBUCAPURDUE PHARMAFilm (Soluble)BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 75 MCGCancelled Post Market
02465248BELBUCAPURDUE PHARMAFilm (Soluble)BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 150 MCGCancelled Post Market
02465256BELBUCAPURDUE PHARMAFilm (Soluble)BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 300 MCGCancelled Post Market
02408090MYLAN-BUPRENORPHINE/NALOXONEMYLAN PHARMACEUTICALS ULCTabletBUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 2 MG; NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) 0.5 MGCancelled Post Market
02408104MYLAN-BUPRENORPHINE/NALOXONEMYLAN PHARMACEUTICALS ULCTabletBUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 8 MG; NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) 2 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
254982021-03-22Supplement to an Abbreviated New Drug Submission (SANDS)PRODUCT NAME CHANGE. UPDATING PRODUCT MONOGRAPH AND LABELLING
230292019-12-17Abbreviated New Drug Submission (ANDS)Administrative: Mergey/Buy-out
179942016-04-18Abbreviated New Drug Submission (ANDS)
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