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APO-FLECAINIDE DIN 02275538

Status: Marketed
Holder: APOTEX INC
Molecule: FLECAINIDE ACETATE
Available to quote

Health Canada record

Active ingredient(s)FLECAINIDE ACETATE 50 MG
Dosage formTablet
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCC01BC04 FLECAINIDE
Original market date08-May-2006
Current status date15-Dec-2017
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 FLECAINIDE ACETATE

DINProductCompanyFormStrengthStatus
02516063AG-FLECAINIDEANGITA PHARMA INC.TabletFLECAINIDE ACETATE 50 MGMarketed
02516071AG-FLECAINIDEANGITA PHARMA INC.TabletFLECAINIDE ACETATE 100 MGMarketed
02275546APO-FLECAINIDEAPOTEX INCTabletFLECAINIDE ACETATE 100 MGMarketed
02459957AURO-FLECAINIDEAURO PHARMA INCTabletFLECAINIDE ACETATE 50 MGMarketed
02459965AURO-FLECAINIDEAURO PHARMA INCTabletFLECAINIDE ACETATE 100 MGMarketed
02534819FLECAINIDESANIS HEALTH INCTabletFLECAINIDE ACETATE 100 MGMarketed
02534800FLECAINIDESANIS HEALTH INCTabletFLECAINIDE ACETATE 50 MGMarketed
02493705JAMP FLECAINIDEJAMP PHARMA CORPORATIONTabletFLECAINIDE ACETATE 50 MGMarketed
02493713JAMP FLECAINIDEJAMP PHARMA CORPORATIONTabletFLECAINIDE ACETATE 100 MGMarketed
02476185MAR-FLECAINIDEMARCAN PHARMACEUTICALS INCTabletFLECAINIDE ACETATE 100 MGDormant
02476177MAR-FLECAINIDEMARCAN PHARMACEUTICALS INCTabletFLECAINIDE ACETATE 50 MGDormant
02530066NRA-FLECAINIDENORA PHARMA INCTabletFLECAINIDE ACETATE 50 MGCancelled Post Market
02530074NRA-FLECAINIDENORA PHARMA INCTabletFLECAINIDE ACETATE 100 MGCancelled Post Market
01966197TAMBOCORBAUSCH HEALTH, CANADA INC.TabletFLECAINIDE ACETATE 50 MGDormant
01966200TAMBOCORBAUSCH HEALTH, CANADA INC.TabletFLECAINIDE ACETATE 100 MGDormant

Notices of Compliance

NOCDateSubmissionReason
200282017-11-09Abbreviated New Drug Submission (ANDS)Labelling Assessment and Administrative: Transfer of Drug Identification Number(s)
114732010-06-02Abbreviated New Drug Submission (ANDS)Manufacturer and product name change
77132006-01-27Abbreviated New Drug Submission (ANDS)

International API supply for FLECAINIDE ACETATE

8 valid EDQM Certificates of Suitability from 8 holders. 10 active FDA Drug Master Files.

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