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APO-COLESEVELAM DIN 02494051

Status: Marketed
Holder: APOTEX INC
Molecule: COLESEVELAM HYDROCHLORIDE
Available to quote

Health Canada record

Active ingredient(s)COLESEVELAM HYDROCHLORIDE 625 MG
Dosage formTablet
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCC10AC04 COLESEVELAM
Original market date23-Jul-2020
Current status date23-Jul-2020
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 COLESEVELAM HYDROCHLORIDE

DINProductCompanyFormStrengthStatus
02566869JAMP COLESEVELAMJAMP PHARMA CORPORATIONTabletCOLESEVELAM HYDROCHLORIDE 625 MGApproved
02373955LODALISBAUSCH HEALTH, CANADA INC.TabletCOLESEVELAM HYDROCHLORIDE 625 MGMarketed
02432463LODALISBAUSCH HEALTH, CANADA INC.Powder For SuspensionCOLESEVELAM HYDROCHLORIDE 3.75 GDormant

Notices of Compliance

NOCDateSubmissionReason
228952019-11-12Abbreviated New Drug Submission (ANDS)

International API supply for COLESEVELAM HYDROCHLORIDE

8 active FDA Drug Master Files.

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