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ACETYLCYSTEINE SOLUTION DIN 02243098

Status: Marketed
Holder: SANDOZ CANADA INCORPORATED
Molecule: ACETYLCYSTEINE
Available to quote

Health Canada record

Active ingredient(s)ACETYLCYSTEINE 200 MG
Dosage formSolution
RouteIntravenous; Inhalation; Oral
ScheduleETHICAL
ClassHuman
ATCR05CB01 ACETYLCYSTEINE
Original market date27-Apr-2001
Current status date10-May-2022
SourceHealth Canada DPD

Establishment licence of the holder

Sandoz Canada Incorporated — licence 101370, currently licensed, last inspection rating C (2025-02-25).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing ACETYLCYSTEINE

DINProductCompanyFormStrengthStatus
02534908ACETYLCYSTEINE INJECTIONEUGIA PHARMA INC.SolutionACETYLCYSTEINE 200 MGApproved
02528274ACETYLCYSTEINE INJECTIONAURO PHARMA INCSolutionACETYLCYSTEINE 200 MGApproved
02459906ACETYLCYSTEINE SOLUTION USPHIKMA CANADA LIMITEDSolutionACETYLCYSTEINE 200 MGMarketed
02538431ACETYLCYSTEINE SOLUTION USPSTERIMAX INCSolutionACETYLCYSTEINE 200 MGMarketed
02300435ACETYLCYSTEINE INJECTIONTELIGENT OUSolutionACETYLCYSTEINE 200 MGCancelled Post Market
02091526MUCOMYSTWELLSPRING PHARMACEUTICAL CANADA CORPSolutionACETYLCYSTEINE 200 MGCancelled Post Market
00606235MUCOMYST INJ 200MG/MLBRISTOL LABS DIVISION OF BRISTOL-MYERS SQUIBBLiquidACETYLCYSTEINE 200 MGCancelled Post Market
02181460PARVOLEXMYLAN PHARMACEUTICALS ULCLiquidACETYLCYSTEINE 200 MGCancelled Post Market
02094738PARVOLEX LIQ IV 200MG/MLBIONICHE PHARMA (CANADA) LTDLiquidACETYLCYSTEINE 200 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
75682005-10-28Abbreviated New Drug Submission (ANDS)MANUFACTURER NAME CHANGE
9352000-12-11Abbreviated New Drug Submission (ANDS)

International API supply for ACETYLCYSTEINE

11 valid EDQM Certificates of Suitability from 10 holders. 7 active FDA Drug Master Files.

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