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DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USP DIN 02467976

Status: Marketed
Holder: JUNO PHARMA CANADA INC.
Molecule: DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)
Available to quote

Health Canada record

Active ingredient(s)DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100 MCG
Dosage formSolution
RouteIntravenous
SchedulePRESCRIPTION
ClassHuman
ATCN05CM18 DEXMEDETOMIDINE
Original market date15-Jan-2019
Current status date20-Feb-2026
SourceHealth Canada DPD

Establishment licence of the holder

Juno Pharma Canada Inc. — licence 3-002916, currently licensed, last inspection rating C (2025-11-24).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)

DINProductCompanyFormStrengthStatus
02464381DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTIONAURO PHARMA INCSolutionDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100 MCGMarketed
02477327DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTIONACCORD HEALTHCARE INCSolutionDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100 MCGMarketed
02528886DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTIONEUGIA PHARMA INC.SolutionDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100 MCGMarketed
02537095DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION USPHIKMA CANADA LIMITEDSolutionDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100 MCGApproved
02513978DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USPBAXTER CORPORATIONSolutionDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100 MCGMarketed
02536463DEXMEDETOMIDINE HYDROCHLORIDE INJECTIONFRESENIUS KABI CANADA LTDSolutionDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 4 MCGApproved
02487365DEXMEDETOMIDINE HYDROCHLORIDE INJECTIONJUNO PHARMA CANADA INC.SolutionDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 200 MCGMarketed
02487373DEXMEDETOMIDINE HYDROCHLORIDE INJECTIONJUNO PHARMA CANADA INC.SolutionDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 400 MCGMarketed
02537109DEXMEDETOMIDINE HYDROCHLORIDE INJECTIONHIKMA CANADA LIMITEDSolutionDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 4 MCGMarketed
02437147PRECEDEXPFIZER CANADA ULCSolutionDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 4 MCGMarketed
02493314DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTIONSANDOZ CANADA INCORPORATEDSolutionDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100 MCGCancelled Pre Market
02539152DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USPOMEGA LABORATORIES LIMITEDSolutionDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100 MCGCancelled Pre Market
02539470DEXMEDETOMIDINE HYDROCHLORIDE INJECTIONOMEGA LABORATORIES LIMITEDSolutionDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 400 MCGCancelled Pre Market
02539462DEXMEDETOMIDINE HYDROCHLORIDE INJECTIONOMEGA LABORATORIES LIMITEDSolutionDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 200 MCGCancelled Pre Market
02339366PRECEDEXPFIZER CANADA ULCSolutionDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100 MCGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
369362026-02-20Abbreviated New Drug Submission (ANDS)Administrative: Merger/Buy-out
238682020-07-08Abbreviated New Drug Submission (ANDS)Administrative: Manufacturer Name Change
216892019-01-03Abbreviated New Drug Submission (ANDS)
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