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APO-VARENICLINE DIN 02435675

Status: Marketed
Holder: APOTEX INC
Molecule: VARENICLINE (VARENICLINE TARTRATE)
Available to quote

Health Canada record

Active ingredient(s)VARENICLINE (VARENICLINE TARTRATE) 0.5 MG; VARENICLINE (VARENICLINE TARTRATE) 1 MG
Dosage formKit; Tablet
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCN07BA03 VARENICLINE
Original market date12-Jun-2018
Current status date23-Dec-2024
SourceHealth Canada DPD

Establishment licence of the holder

Apotex Inc — licence 100375, currently licensed, last inspection rating C (2026-04-21).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing VARENICLINE (VARENICLINE TARTRATE)

DINProductCompanyFormStrengthStatus
02419882APO-VARENICLINEAPOTEX INCTabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MGMarketed
02419890APO-VARENICLINEAPOTEX INCTabletVARENICLINE (VARENICLINE TARTRATE) 1 MGMarketed
02554453AURO-VARENICLINEAURO PHARMA INCTabletVARENICLINE (VARENICLINE TARTRATE) 1 MGMarketed
02554445AURO-VARENICLINEAURO PHARMA INCTabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MGMarketed
02546965MINT-VARENICLINEMINT PHARMACEUTICALS INCKit; TabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MG; VARENICLINE (VARENICLINE TARTRATE) 1 MGMarketed
02546957MINT-VARENICLINEMINT PHARMACEUTICALS INCTabletVARENICLINE (VARENICLINE TARTRATE) 1 MGMarketed
02546949MINT-VARENICLINEMINT PHARMACEUTICALS INCTabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MGMarketed
02542986NRA-VARENICLINENORA PHARMA INCTablet; KitVARENICLINE (VARENICLINE TARTRATE) 0.5 MG; VARENICLINE (VARENICLINE TARTRATE) 1 MGMarketed
02542978NRA-VARENICLINENORA PHARMA INCTabletVARENICLINE (VARENICLINE TARTRATE) 1 MGMarketed
02542951NRA-VARENICLINENORA PHARMA INCTabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MGMarketed
02559897ZDS-VARENICLINEZYDUS LIFESCIENCES LIMITEDTabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MGMarketed
02559900ZDS-VARENICLINEZYDUS LIFESCIENCES LIMITEDTabletVARENICLINE (VARENICLINE TARTRATE) 1 MGMarketed
02291177CHAMPIXPFIZER CANADA ULCTabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MGCancelled Post Market
02291185CHAMPIXPFIZER CANADA ULCTabletVARENICLINE (VARENICLINE TARTRATE) 1 MGCancelled Post Market
02298309CHAMPIXPFIZER CANADA ULCTablet; KitVARENICLINE (VARENICLINE TARTRATE) 0.5 MG; VARENICLINE (VARENICLINE TARTRATE) 1 MGCancelled Post Market
02438445GD-VARENICLINEGENMED A DIVISION OF PFIZER CANADA ULCKit; TabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MG; VARENICLINE (VARENICLINE TARTRATE) 1 MGCancelled Pre Market
02438437GD-VARENICLINEGENMED A DIVISION OF PFIZER CANADA ULCTabletVARENICLINE (VARENICLINE TARTRATE) 1 MGCancelled Pre Market
02438429GD-VARENICLINEGENMED A DIVISION OF PFIZER CANADA ULCTabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MGCancelled Pre Market
02485869PMS-VARENICLINEPHARMASCIENCE INCKit; TabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MG; VARENICLINE (VARENICLINE TARTRATE) 1 MGCancelled Pre Market
02458519PMS-VARENICLINEPHARMASCIENCE INCTabletVARENICLINE (VARENICLINE TARTRATE) 1 MGCancelled Pre Market
02458500PMS-VARENICLINEPHARMASCIENCE INCTabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MGCancelled Pre Market
02426781TEVA-VARENICLINETEVA CANADA LIMITEDTabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MG; VARENICLINE (VARENICLINE TARTRATE) 1 MGCancelled Post Market
02426234TEVA-VARENICLINETEVA CANADA LIMITEDTabletVARENICLINE (VARENICLINE TARTRATE) 1 MGDormant
02426226TEVA-VARENICLINETEVA CANADA LIMITEDTabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MGDormant

Notices of Compliance

NOCDateSubmissionReason
204432018-02-02Supplement to an Abbreviated New Drug Submission (SANDS)NEW PRESENTATION
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