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SEPTRA PEDIATRIC ORAL SUSPENSION DIN 02563495

Status: Marketed
Holder: ASPEN PHARMACARE CANADA INC.
Molecule: SULFAMETHOXAZOLE

Health Canada record

Active ingredient(s)SULFAMETHOXAZOLE 40 MG; TRIMETHOPRIM 8 MG
Dosage formSuspension
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCJ01EE01 SULFAMETHOXAZOLE AND TRIMETHOPRIM
Original market date17-Jul-2026
Current status date17-Jul-2026
SourceHealth Canada DPD

Establishment licence of the holder

Aspen Pharmacare Canada Inc. — licence 3-002349, currently licensed, last inspection rating C (2026-03-12).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing SULFAMETHOXAZOLE

DINProductCompanyFormStrengthStatus
02534746SULFAMETHOXAZOLE AND TRIMETHOPRIM FOR INJECTION, USPEUGIA PHARMA INC.SolutionSULFAMETHOXAZOLE 80 MG; TRIMETHOPRIM 16 MGMarketed
02525917SULFAMETHOXAZOLE AND TRIMETHOPRIM FOR INJECTION, USPAURO PHARMA INCSolutionSULFAMETHOXAZOLE 80 MG; TRIMETHOPRIM 16 MGMarketed
00445274SULFATRIMAA PHARMA INCTabletSULFAMETHOXAZOLE 400 MG; TRIMETHOPRIM 80 MGMarketed
00445282SULFATRIM DSAA PHARMA INCTabletSULFAMETHOXAZOLE 800 MG; TRIMETHOPRIM 160 MGMarketed
00445266SULFATRIM PEDIATRICAA PHARMA INCTabletSULFAMETHOXAZOLE 100 MG; TRIMETHOPRIM 20 MGMarketed
00421480APO SULFAMETHOXAZOLE TAB 500MGAPOTEX INCTabletSULFAMETHOXAZOLE 500 MGCancelled Post Market
00846465APO-SULFATRIM ORAL SUSPENSIONAPOTEX INCSuspensionSULFAMETHOXAZOLE 40 MG; TRIMETHOPRIM 8 MGCancelled Post Market
00272485BACTRIM ROCHE SUSPENSION PAEDIATRICHOFFMANN-LA ROCHE LIMITEDSuspensionSULFAMETHOXAZOLE 200 MG; TRIMETHOPRIM 40 MGCancelled Post Market
00272469BACTRIM ROCHE TABHOFFMANN-LA ROCHE LIMITEDTabletSULFAMETHOXAZOLE 400 MG; TRIMETHOPRIM 80 MGCancelled Post Market
00865753NU-COTRIMOX SUS 40/8MG/MLNU-PHARM INCSuspensionSULFAMETHOXAZOLE 40 MG; TRIMETHOPRIM 8 MGCancelled Post Market
00865710NU-COTRIMOX TAB 400/80MGNU-PHARM INCTabletSULFAMETHOXAZOLE 400 MG; TRIMETHOPRIM 80 MGCancelled Post Market
00865729NU-COTRIMOX-DS TAB 800/160MGNU-PHARM INCTabletSULFAMETHOXAZOLE 800 MG; TRIMETHOPRIM 160 MGCancelled Post Market
02530023SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, BPJUNO PHARMACEUTICALS CORP.SolutionSULFAMETHOXAZOLE 80 MG; TRIMETHOPRIM 16 MGCancelled Pre Market
00516759SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETSD.C. LABS LIMITEDTabletSULFAMETHOXAZOLE 400 MG; TRIMETHOPRIM 80 MGCancelled Post Market
00516767SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETSD.C. LABS LIMITEDTabletSULFAMETHOXAZOLE 800 MG; TRIMETHOPRIM 160 MGCancelled Post Market
00444650SULFAMETHOXAZOLE TAB 500MGPRO DOC LIMITEETabletSULFAMETHOXAZOLE 500 MGCancelled Post Market
00726540TEVA-TRIMELTEVA CANADA LIMITEDSuspensionSULFAMETHOXAZOLE 40 MG; TRIMETHOPRIM 8 MGDormant
00885932TRISULFA DS TABJAAPHARM CANADA INC.TabletSULFAMETHOXAZOLE 800 MG; TRIMETHOPRIM 160 MGCancelled Post Market
00885940TRISULFA S SUSPENSIONJAAPHARM CANADA INC.SuspensionSULFAMETHOXAZOLE 40 MG; TRIMETHOPRIM 8 MGCancelled Post Market
00885924TRISULFA TABJAAPHARM CANADA INC.TabletSULFAMETHOXAZOLE 400 MG; TRIMETHOPRIM 80 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
365032025-12-05New Drug Submission (NDS)Administrative: Change in product name

International API supply for SULFAMETHOXAZOLE

2 valid EDQM Certificates of Suitability from 2 holders. 5 active FDA Drug Master Files.

Special Access Programme

This molecule appears on Health Canada's list of drugs most often requested through the Special Access Programme.

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