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GEMCITABINE FOR INJECTION, USP DIN 02407299

Status: Cancelled Pre Market
Holder: MYLAN PHARMACEUTICALS ULC
Molecule: GEMCITABINE (GEMCITABINE HYDROCHLORIDE)

Health Canada record

Active ingredient(s)GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MG
Dosage formPowder For Solution
RouteIntravenous
SchedulePRESCRIPTION
ClassHuman
ATCL01BC05 GEMCITABINE
Original market date
Current status date08-May-2017
SourceHealth Canada DPD

Establishment licence of the holder

Mylan Pharmaceuticals ULC — licence 101774, currently licensed, last inspection rating C (2026-02-24).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing GEMCITABINE (GEMCITABINE HYDROCHLORIDE)

DINProductCompanyFormStrengthStatus
02412071GEMCITABINE FOR INJECTIONFRESENIUS KABI CANADA LTDPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MGApproved
02412101GEMCITABINE FOR INJECTIONFRESENIUS KABI CANADA LTDPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 2 GApproved
02412098GEMCITABINE FOR INJECTIONFRESENIUS KABI CANADA LTDPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 GApproved
02409925GEMCITABINE FOR INJECTION USPGENERIC MEDICAL PARTNERS INCPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MGApproved
02409933GEMCITABINE FOR INJECTION USPGENERIC MEDICAL PARTNERS INCPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 GApproved
02412292GEMCITABINE INJECTIONSANDOZ CANADA INCORPORATEDSolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 40 MGMarketed
02565641GEMCITABINE INJECTIONHIKMA CANADA LIMITEDSolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 38 MGApproved
02455382GEMCITABINE INJECTIONAPOTEX INCSolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 38 MGApproved
02402831GEMCITABINE INJECTIONPFIZER CANADA ULCSolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 38 MGMarketed
02433117ACT GEMCITABINEACTAVIS PHARMA COMPANYSolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 38 MGCancelled Post Market
02436191ACT GEMCITABINEACTAVIS PHARMA COMPANYPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MGCancelled Pre Market
02436205ACT GEMCITABINEACTAVIS PHARMA COMPANYPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 GCancelled Pre Market
02409054AJ-GEMCITABINEAGILA JAMP CANADA INCPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MGCancelled Pre Market
02409062AJ-GEMCITABINEAGILA JAMP CANADA INCPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 GCancelled Pre Market
02409070AJ-GEMCITABINEAGILA JAMP CANADA INCPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 2 GCancelled Pre Market
02402858GEMCITABINE FOR INJECTIONTELIP, LLC, A SUBSIDIARY OF TELIGENT, INC.Powder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MGCancelled Pre Market
02402866GEMCITABINE FOR INJECTIONTELIP, LLC, A SUBSIDIARY OF TELIGENT, INC.Powder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 GCancelled Pre Market
02370034GEMCITABINE FOR INJECTIONACCORD HEALTHCARE INCPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 2 GCancelled Post Market
02324210GEMCITABINE FOR INJECTIONACCORD HEALTHCARE INCPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 GCancelled Post Market
02324202GEMCITABINE FOR INJECTIONACCORD HEALTHCARE INCPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MGCancelled Post Market
02305534GEMCITABINE FOR INJECTIONTEVA CANADA LIMITEDPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 GCancelled Post Market
02305526GEMCITABINE FOR INJECTIONTEVA CANADA LIMITEDPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MGCancelled Post Market
02423510GEMCITABINE FOR INJECTION CONCENTRATEACCORD HEALTHCARE INCSolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 100 MGCancelled Post Market
02437155GEMCITABINE FOR INJECTION, USPDR REDDY'S LABORATORIES LTDPowderGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MGCancelled Pre Market
02298775GEMCITABINE FOR INJECTION, USPHOSPIRA HEALTHCARE ULCPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MGCancelled Post Market
02318741GEMCITABINE FOR INJECTION, USPHOSPIRA HEALTHCARE ULCPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 2 GCancelled Post Market
02407310GEMCITABINE FOR INJECTION, USPMYLAN PHARMACEUTICALS ULCPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 2 GCancelled Post Market
02407302GEMCITABINE FOR INJECTION, USPMYLAN PHARMACEUTICALS ULCPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 GCancelled Post Market
02437171GEMCITABINE FOR INJECTION, USPDR REDDY'S LABORATORIES LTDPowderGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 2 GCancelled Pre Market
02298783GEMCITABINE FOR INJECTION, USPHOSPIRA HEALTHCARE ULCPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 GCancelled Post Market
02437163GEMCITABINE FOR INJECTION, USPDR REDDY'S LABORATORIES LTDPowderGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 GCancelled Pre Market
02302098GEMCITABINE HYDROCHLORIDE FOR INJECTIONSANDOZ CANADA INCORPORATEDPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MGCancelled Post Market
02302101GEMCITABINE HYDROCHLORIDE FOR INJECTIONSANDOZ CANADA INCORPORATEDPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 GCancelled Post Market
02555468GEMCITABINE INJECTIONJUNO PHARMACEUTICALS CORP.SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 38 MGCancelled Pre Market
02373173GEMCITABINE SUN FOR INJECTIONTARO PHARMACEUTICALS INCPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MGCancelled Post Market
02373181GEMCITABINE SUN FOR INJECTIONTARO PHARMACEUTICALS INCPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 GCancelled Post Market
02230309GEMZAR (1GM/VIAL)ELI LILLY CANADA INCPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 GCancelled Post Market
02230308GEMZAR (200MG/VIAL)ELI LILLY CANADA INCPowder For SolutionGEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
156232014-05-22Abbreviated New Drug Submission (ANDS)TRANSFER OF DRUG IDENTIFICATION NUMBERS
144072013-05-29Abbreviated New Drug Submission (ANDS)
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