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APO-MIDODRINE DIN 02278685

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

Health Canada record

Active ingredient(s)MIDODRINE HYDROCHLORIDE 5 MG
Dosage formTablet
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCC01CA17 MIDODRINE
Original market date13-Jun-2006
Current status date10-Dec-2018
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 MIDODRINE HYDROCHLORIDE

DINProductCompanyFormStrengthStatus
02278677APO-MIDODRINEAPOTEX INCTabletMIDODRINE HYDROCHLORIDE 2.5 MGMarketed
02517701JAMP MIDODRINEJAMP PHARMA CORPORATIONTabletMIDODRINE HYDROCHLORIDE 2.5 MGMarketed
02517728JAMP MIDODRINEJAMP PHARMA CORPORATIONTabletMIDODRINE HYDROCHLORIDE 5 MGMarketed
02547120M-MIDODRINEMANTRA PHARMA INCTabletMIDODRINE HYDROCHLORIDE 5 MGMarketed
02547112M-MIDODRINEMANTRA PHARMA INCTabletMIDODRINE HYDROCHLORIDE 2.5 MGMarketed
02473984MAR-MIDODRINEMARCAN PHARMACEUTICALS INCTabletMIDODRINE HYDROCHLORIDE 2.5 MGMarketed
02473992MAR-MIDODRINEMARCAN PHARMACEUTICALS INCTabletMIDODRINE HYDROCHLORIDE 5 MGMarketed
02533200MIDODRINESANIS HEALTH INCTabletMIDODRINE HYDROCHLORIDE 2.5 MGMarketed
02533219MIDODRINESANIS HEALTH INCTabletMIDODRINE HYDROCHLORIDE 5 MGMarketed
01934406AMATINESHIRE PHARMA CANADA ULCTabletMIDODRINE HYDROCHLORIDE 5 MGCancelled Post Market
01934392AMATINESHIRE PHARMA CANADA ULCTabletMIDODRINE HYDROCHLORIDE 2.5 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
214512018-10-19Abbreviated New Drug Submission (ANDS)Labelling Assessment and Administrative: Change in product Ownership
114292010-05-27Abbreviated New Drug Submission (ANDS)Manufacturer and product name change
78272006-03-13Abbreviated New Drug Submission (ANDS)

International API supply for MIDODRINE HYDROCHLORIDE

14 active FDA Drug Master Files.

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