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NOVO-DIFLUNISAL DIN 02048507

Status: Cancelled Post Market
Holder: TEVA CANADA LIMITED
Molecule: DIFLUNISAL

Health Canada record

Active ingredient(s)DIFLUNISAL 500 MG
Dosage formTablet
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCN02BA11 DIFLUNISAL
Original market date31-Dec-1993
Current status date30-Apr-2018
SourceHealth Canada DPD

Establishment licence of the holder

Teva Canada Limited — licence 101810, currently licensed, last inspection rating C (2025-03-04).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing DIFLUNISAL

DINProductCompanyFormStrengthStatus
02039486DIFLUNISALAA PHARMA INCTabletDIFLUNISAL 250 MGDormant
02039494DIFLUNISALAA PHARMA INCTabletDIFLUNISAL 500 MGDormant
02130904DIFLUNISAL-250 - TAB 250MGPRO DOC LIMITEETabletDIFLUNISAL 250 MGCancelled Post Market
02130912DIFLUNISAL-500 - TAB 500MGPRO DOC LIMITEETabletDIFLUNISAL 500 MGCancelled Post Market
00587699DOLOBID TAB 250MGMERCK FROSST CANADA & CIE, MERCK FROSST CANADA & CO.TabletDIFLUNISAL 250 MGCancelled Post Market
00576131DOLOBID TAB 500MGMERCK FROSST CANADA & CIE, MERCK FROSST CANADA & CO.TabletDIFLUNISAL 500 MGCancelled Post Market
02048493NOVO-DIFLUNISALTEVA CANADA LIMITEDTabletDIFLUNISAL 250 MGCancelled Post Market
02058405NU-DIFLUNISAL TAB 250MGNU-PHARM INCTabletDIFLUNISAL 250 MGCancelled Post Market
02058413NU-DIFLUNISAL TAB 500MGNU-PHARM INCTabletDIFLUNISAL 500 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
157392014-06-20New Drug Submission (NDS)MANUFACTURER NAME CHANGE
4362002-07-16New Drug Submission (NDS)ALTERNATE FORMULATION, MANUFACTURING PROCEDURE AND MANUFACTURING SITE

International API supply for DIFLUNISAL

4 active FDA Drug Master Files.

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