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LEVOFLOXACIN IN 5% DEXTROSE INJECTION DIN 02537079

Status: Marketed
Holder: HIKMA CANADA LIMITED
Molecule: LEVOFLOXACIN

Health Canada record

Active ingredient(s)LEVOFLOXACIN 5 MG
Dosage formSolution
RouteIntravenous
SchedulePRESCRIPTION
ClassHuman
ATCJ01MA12 LEVOFLOXACIN
Original market date23-Oct-2023
Current status date23-Oct-2023
SourceHealth Canada DPD

Establishment licence of the holder

Hikma Canada Limited — licence 3-002579, currently licensed, last inspection rating C (2022-04-26).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing LEVOFLOXACIN

DINProductCompanyFormStrengthStatus
02460122LEVOFLOXACIN IN 5% DEXTROSE INJECTIONSTERIMAX INCSolutionLEVOFLOXACIN 5 MGApproved
02314932LEVOFLOXACIN IN 5% DEXTROSE INJECTIONPFIZER CANADA ULCSolutionLEVOFLOXACIN 5 MGMarketed
02361035AVA-LEVOFLOXACINAVANSTRA INCTabletLEVOFLOXACIN 500 MGCancelled Post Market
02361027AVA-LEVOFLOXACINAVANSTRA INCTabletLEVOFLOXACIN 250 MGCancelled Post Market
02236841LEVAQUINJANSSEN INCTabletLEVOFLOXACIN 250 MGCancelled Post Market
02236840LEVAQUIN 25MG/MLJANSSEN INCSolutionLEVOFLOXACIN 25 MGCancelled Post Market
02236842LEVAQUIN 500MGJANSSEN INCTabletLEVOFLOXACIN 500 MGCancelled Post Market
02236839LEVAQUIN 5MG/MLJANSSEN INCSolutionLEVOFLOXACIN 5 MGCancelled Post Market
02246804LEVAQUIN 750MGJANSSEN INCTabletLEVOFLOXACIN 750 MGCancelled Post Market
02358670NTP-LEVOFLOXACINTEVA CANADA LIMITEDTabletLEVOFLOXACIN 750 MGCancelled Pre Market
02358662NTP-LEVOFLOXACINTEVA CANADA LIMITEDTabletLEVOFLOXACIN 500 MGCancelled Pre Market
02358654NTP-LEVOFLOXACINTEVA CANADA LIMITEDTabletLEVOFLOXACIN 250 MGCancelled Pre Market

Notices of Compliance

NOCDateSubmissionReason
304832023-04-05Abbreviated New Drug Submission (ANDS)

International API supply for LEVOFLOXACIN

23 active FDA Drug Master Files.

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