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CAPECITABINE DIN 02528126

Status: Approved
Holder: SIVEM PHARMACEUTICALS ULC
Molecule: CAPECITABINE

Health Canada record

Active ingredient(s)CAPECITABINE 150 MG
Dosage formTablet
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCL01BC06 CAPECITABINE
Original market date
Current status date20-Jun-2022
SourceHealth Canada DPD

Establishment licence of the holder

Sivem Pharmaceuticals ULC — licence 101965, currently licensed, last inspection rating C (2025-02-04).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing CAPECITABINE

DINProductCompanyFormStrengthStatus
02426757ACH-CAPECITABINEACCORD HEALTHCARE INCTabletCAPECITABINE 150 MGMarketed
02426765ACH-CAPECITABINEACCORD HEALTHCARE INCTabletCAPECITABINE 500 MGMarketed
02434512APO-CAPECITABINEAPOTEX INCTabletCAPECITABINE 500 MGApproved
02434504APO-CAPECITABINEAPOTEX INCTabletCAPECITABINE 150 MGApproved
02528150CAPECITABINESIVEM PHARMACEUTICALS ULCTabletCAPECITABINE 500 MGApproved
02514982CAPECITABINESANIS HEALTH INCTabletCAPECITABINE 150 MGMarketed
02514990CAPECITABINESANIS HEALTH INCTabletCAPECITABINE 500 MGMarketed
02519879CAPECITABINEJAMP PHARMA CORPORATIONTabletCAPECITABINE 150 MGMarketed
02519887CAPECITABINEJAMP PHARMA CORPORATIONTabletCAPECITABINE 500 MGMarketed
02508001MINT-CAPECITABINEMINT PHARMACEUTICALS INCTabletCAPECITABINE 150 MGApproved
02508028MINT-CAPECITABINEMINT PHARMACEUTICALS INCTabletCAPECITABINE 500 MGMarketed
02421917SANDOZ CAPECITABINESANDOZ CANADA INCORPORATEDTabletCAPECITABINE 150 MGMarketed
02421925SANDOZ CAPECITABINESANDOZ CANADA INCORPORATEDTabletCAPECITABINE 500 MGMarketed
02457490TARO-CAPECITABINETARO PHARMACEUTICALS INCTabletCAPECITABINE 150 MGMarketed
02457504TARO-CAPECITABINETARO PHARMACEUTICALS INCTabletCAPECITABINE 500 MGMarketed
02400022TEVA-CAPECITABINETEVA CANADA LIMITEDTabletCAPECITABINE 150 MGCancelled Post Market
02400030TEVA-CAPECITABINETEVA CANADA LIMITEDTabletCAPECITABINE 500 MGCancelled Post Market
02238453XELODACHEPLAPHARM ARZNEIMITTEL GMBHTabletCAPECITABINE 150 MGCancelled Post Market
02238454XELODACHEPLAPHARM ARZNEIMITTEL GMBHTabletCAPECITABINE 500 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
284342022-06-20Abbreviated New Drug Submission (ANDS)Administrative: Licensing Agreement Between Two Companies

International API supply for CAPECITABINE

14 valid EDQM Certificates of Suitability from 14 holders. 18 active FDA Drug Master Files.

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