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CEFEPIME FOR INJECTION USP DIN 02499096

Status: Marketed
Holder: HIKMA CANADA LIMITED
Molecule: CEFEPIME (CEFEPIME HYDROCHLORIDE)

Health Canada record

Active ingredient(s)CEFEPIME (CEFEPIME HYDROCHLORIDE) 2 G
Dosage formPowder For Solution
RouteIntravenous
SchedulePRESCRIPTION
ClassHuman
ATCJ01DE01 CEFEPIME
Original market date09-Jul-2021
Current status date25-May-2022
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 CEFEPIME (CEFEPIME HYDROCHLORIDE)

DINProductCompanyFormStrengthStatus
02467496APO-CEFEPIMEAPOTEX INCPowder For SolutionCEFEPIME (CEFEPIME HYDROCHLORIDE) 1 GMarketed
02467518APO-CEFEPIMEAPOTEX INCPowder For SolutionCEFEPIME (CEFEPIME HYDROCHLORIDE) 2 GMarketed
02319020CEFEPIME FOR INJECTIONAPOTEX INCPowder For SolutionCEFEPIME (CEFEPIME HYDROCHLORIDE) 1 GApproved
02499088CEFEPIME FOR INJECTION USPHIKMA CANADA LIMITEDPowder For SolutionCEFEPIME (CEFEPIME HYDROCHLORIDE) 1 GApproved
02463997CEFEPIME FOR INJECTION, USPQILU PHARMACEUTICAL CO., LTD.Powder For SolutionCEFEPIME (CEFEPIME HYDROCHLORIDE) 1 GApproved
02464004CEFEPIME FOR INJECTION, USPQILU PHARMACEUTICAL CO., LTD.Powder For SolutionCEFEPIME (CEFEPIME HYDROCHLORIDE) 2 GApproved
02319039CEFEPIME FOR INJECTIONAPOTEX INCPowder For SolutionCEFEPIME (CEFEPIME HYDROCHLORIDE) 2 GDormant
02163632MAXIPIME FOR INJECTION -PWS IV IM 1GBRISTOL-MYERS SQUIBB CANADAPowder For SolutionCEFEPIME (CEFEPIME HYDROCHLORIDE) 1 GCancelled Post Market
02163640MAXIPIME FOR INJECTION-PWS IV 2GMBRISTOL-MYERS SQUIBB CANADAPowder For SolutionCEFEPIME (CEFEPIME HYDROCHLORIDE) 2 GCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
282592022-05-25Abbreviated New Drug Submission (ANDS)Administrative: Merger/Buy-out
258592021-05-12Abbreviated New Drug Submission (ANDS)CHANGE IN PRODUCT OWNERSHIP
248922020-12-22Abbreviated New Drug Submission (ANDS)CHANGE IN PRODUCT OWNERSHIP
236232020-05-19Abbreviated New Drug Submission (ANDS)
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