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DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USP DIN 02513978

Status: Marketed
Holder: BAXTER CORPORATION
Molecule: DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)

Health Canada record

Active ingredient(s)DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100 MCG
Dosage formSolution
RouteIntravenous
SchedulePRESCRIPTION
ClassHuman
ATCN05CM18 DEXMEDETOMIDINE
Original market date05-Jun-2024
Current status date05-Jun-2024
SourceHealth Canada DPD

Establishment licence of the holder

Baxter Corporation — licence 100278, currently licensed, last inspection rating C (2026-08-11).

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
02528886DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTIONEUGIA PHARMA INC.SolutionDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100 MCGMarketed
02477327DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTIONACCORD HEALTHCARE INCSolutionDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100 MCGMarketed
02537095DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION USPHIKMA CANADA LIMITEDSolutionDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100 MCGApproved
02467976DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USPJUNO PHARMA CANADA INC.SolutionDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100 MCGMarketed
02537109DEXMEDETOMIDINE HYDROCHLORIDE INJECTIONHIKMA CANADA LIMITEDSolutionDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 4 MCGMarketed
02487365DEXMEDETOMIDINE HYDROCHLORIDE INJECTIONJUNO PHARMA CANADA INC.SolutionDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 200 MCGMarketed
02487373DEXMEDETOMIDINE HYDROCHLORIDE INJECTIONJUNO PHARMA CANADA INC.SolutionDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 400 MCGMarketed
02536463DEXMEDETOMIDINE HYDROCHLORIDE INJECTIONFRESENIUS KABI CANADA LTDSolutionDEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 4 MCGApproved
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
254672021-03-19Abbreviated New Drug Submission (ANDS)
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