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TARO-BUDESONIDE DIN 02494264

Status: Marketed
Holder: TARO PHARMACEUTICALS INC
Molecule: BUDESONIDE
Available to quote

Health Canada record

Active ingredient(s)BUDESONIDE 0.125 MG
Dosage formSuspension
RouteInhalation
SchedulePRESCRIPTION
ClassHuman
ATCR03BA02 BUDESONIDE
Original market date04-Jun-2021
Current status date04-Jun-2021
SourceHealth Canada DPD

Establishment licence of the holder

Taro Pharmaceuticals Inc — licence 100232, not currently licensed, last inspection rating C (2025-03-24).

Canadian shortage reports

StatusReasonEstimated resolutionTierUpdated
active0.5MGTier 3 Drug Shortages About & Resources2026-09-04

Other Canadian products containing BUDESONIDE

DINProductCompanyFormStrengthStatus
02518058BREZTRI AEROSPHEREASTRAZENECA CANADA INCAerosol (Metered-Dose)BUDESONIDE 160 MCG; GLYCOPYRRONIUM (GLYCOPYRROLATE) 7.2 MCG; FORMOTEROL FUMARATE DIHYDRATE 5 MCGMarketed
02455889CORTIMENTFERRING INCTablet (Delayed- And Extended-Release)BUDESONIDE 9 MGMarketed
02229293ENTOCORTTILLOTTS PHARMA GMBHCapsule (Sustained-Release)BUDESONIDE 3 MGMarketed
02052431ENTOCORT ENEMATILLOTTS PHARMA GMBHEnema; Tablet; KitBUDESONIDE 2.3 MGMarketed
02493675JORVEZAAVIR PHARMA INC.Tablet (Orally-Disintegrating)BUDESONIDE 1 MGMarketed
02513854JORVEZAAVIR PHARMA INC.Tablet (Orally-Disintegrating)BUDESONIDE 0.5 MGMarketed
02241003MYLAN-BUDESONIDE AQMYLAN PHARMACEUTICALS ULCSpray (Metered-Dose)BUDESONIDE 64 MCGMarketed
02230648MYLAN-BUDESONIDE AQMYLAN PHARMACEUTICALS ULCSpray (Metered-Dose)BUDESONIDE 100 MCGMarketed
02229099PULMICORT NEBUAMP 0.125 MG/MLASTRAZENECA CANADA INCSuspensionBUDESONIDE 0.125 MGMarketed
01978918PULMICORT NEBUAMP 0.25 MG/MLASTRAZENECA CANADA INCSuspensionBUDESONIDE 0.25 MGMarketed
01978926PULMICORT NEBUAMP 0.5 MG/MLASTRAZENECA CANADA INCSuspensionBUDESONIDE 0.5 MGMarketed
00851752PULMICORT TURBUHALERASTRAZENECA CANADA INCPowder (Metered-Dose)BUDESONIDE 200 MCGMarketed
00851760PULMICORT TURBUHALERASTRAZENECA CANADA INCPowder (Metered-Dose)BUDESONIDE 400 MCGMarketed
00852074PULMICORT TURBUHALERASTRAZENECA CANADA INCPowder (Metered-Dose)BUDESONIDE 100 MCGMarketed
02231923RHINOCORT AQUAKENVUE CANADA INC.Spray (Metered-Dose)BUDESONIDE 64 MCGMarketed
02245385SYMBICORT 100 TURBUHALERASTRAZENECA CANADA INCPowderBUDESONIDE 100 MCG; FORMOTEROL FUMARATE DIHYDRATE 6 MCGMarketed
02245386SYMBICORT 200 TURBUHALERASTRAZENECA CANADA INCPowderBUDESONIDE 200 MCG; FORMOTEROL FUMARATE DIHYDRATE 6 MCGMarketed
02248218SYMBICORT FORTE TURBUHALERASTRAZENECA CANADA INCPowderBUDESONIDE 400 MCG; FORMOTEROL FUMARATE DIHYDRATE 12 MCGApproved
02494272TARO-BUDESONIDETARO PHARMACEUTICALS INCSuspensionBUDESONIDE 0.25 MGMarketed
02494280TARO-BUDESONIDETARO PHARMACEUTICALS INCSuspensionBUDESONIDE 0.5 MGMarketed
02465949TEVA-BUDESONIDETEVA CANADA LIMITEDSuspensionBUDESONIDE 0.125 MGMarketed
02465957TEVA-BUDESONIDETEVA CANADA LIMITEDSuspensionBUDESONIDE 0.5 MGMarketed
02535416TEVA-BUDESONIDETEVA CANADA LIMITEDSuspensionBUDESONIDE 0.25 MGMarketed
02498057UCERISBAUSCH HEALTH, CANADA INC.FoamBUDESONIDE 2 MGMarketed
02483874BUDESONIDETILLOTTS PHARMA GMBHCapsule (Sustained-Release)BUDESONIDE 3 MGDormant
01974432RHINOCORT AQUA 100MCGASTRA PHARMA INC.Metered-Dose AerosolBUDESONIDE 100 MCGCancelled Post Market
02035324RHINOCORT TURBUHALER 100 MCG/DOSEASTRAZENECA CANADA INCPowderBUDESONIDE 100 MCGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
229202019-11-20Abbreviated New Drug Submission (ANDS)

International API supply for BUDESONIDE

15 valid EDQM Certificates of Suitability from 14 holders. 28 active FDA Drug Master Files.

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