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APO-ATOVAQUONE DIN 02471949

Status: Approved
Holder: APOTEX INC
Molecule: ATOVAQUONE

Health Canada record

Active ingredient(s)ATOVAQUONE 750 MG
Dosage formSuspension
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCP01AX06 ATOVAQUONE
Original market date
Current status date16-Jan-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 ATOVAQUONE

DINProductCompanyFormStrengthStatus
02466783ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETSGLENMARK PHARMACEUTICALS CANADA INC.TabletATOVAQUONE 250 MG; PROGUANIL HYDROCHLORIDE 100 MGMarketed
02421429ATOVAQUONE PROGUANILSANIS HEALTH INCTabletATOVAQUONE 250 MG; PROGUANIL HYDROCHLORIDE 100 MGMarketed
02556618AURO-ATOVAQUONEAURO PHARMA INCSuspensionATOVAQUONE 750 MGMarketed
02528495GLN-ATOVAQUONEGLENMARK PHARMACEUTICALS CANADA INC.SuspensionATOVAQUONE 750 MGMarketed
02264935MALARONE PEDIATRICGLAXOSMITHKLINE INCTabletATOVAQUONE 62.5 MG; PROGUANIL HYDROCHLORIDE 25.0 MGMarketed
02217422MEPRONGLAXOSMITHKLINE INCSuspensionATOVAQUONE 750 MGMarketed
02402165MYLAN-ATOVAQUONE/PROGUANILMYLAN PHARMACEUTICALS ULCTabletATOVAQUONE 250 MG; PROGUANIL HYDROCHLORIDE 100 MGMarketed
02380927TEVA-ATOVAQUONE PROGUANILTEVA CANADA LIMITEDTabletATOVAQUONE 250 MG; PROGUANIL HYDROCHLORIDE 100 MGMarketed
02009358MEPRON TAB 250MGGLAXO WELLCOME INC.TabletATOVAQUONE 250 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
203362018-01-16Abbreviated New Drug Submission (ANDS)

International API supply for ATOVAQUONE

4 valid EDQM Certificates of Suitability from 4 holders. 12 active FDA Drug Master Files.

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