ACETYLCYSTEINE SOLUTION USP DIN 02459906
Health Canada record
| Active ingredient(s) | ACETYLCYSTEINE 200 MG |
|---|---|
| Dosage form | Solution |
| Route | Inhalation; Oral; Intravenous |
| Schedule | ETHICAL |
| Class | Human |
| ATC | R05CB01 ACETYLCYSTEINE |
| Original market date | 26-Jan-2018 |
| Current status date | 13-Jun-2023 |
| Source | Health Canada DPD |
Establishment licence of the holder
Hikma Canada Limited — licence 3-002579, currently licensed, last inspection rating C (2022-04-26).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing ACETYLCYSTEINE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02534908 | ACETYLCYSTEINE INJECTION | EUGIA PHARMA INC. | Solution | ACETYLCYSTEINE 200 MG | Approved |
| 02528274 | ACETYLCYSTEINE INJECTION | AURO PHARMA INC | Solution | ACETYLCYSTEINE 200 MG | Approved |
| 02243098 | ACETYLCYSTEINE SOLUTION | SANDOZ CANADA INCORPORATED | Solution | ACETYLCYSTEINE 200 MG | Marketed |
| 02538431 | ACETYLCYSTEINE SOLUTION USP | STERIMAX INC | Solution | ACETYLCYSTEINE 200 MG | Marketed |
| 02300435 | ACETYLCYSTEINE INJECTION | TELIGENT OU | Solution | ACETYLCYSTEINE 200 MG | Cancelled Post Market |
| 02091526 | MUCOMYST | WELLSPRING PHARMACEUTICAL CANADA CORP | Solution | ACETYLCYSTEINE 200 MG | Cancelled Post Market |
| 00606235 | MUCOMYST INJ 200MG/ML | BRISTOL LABS DIVISION OF BRISTOL-MYERS SQUIBB | Liquid | ACETYLCYSTEINE 200 MG | Cancelled Post Market |
| 02181460 | PARVOLEX | MYLAN PHARMACEUTICALS ULC | Liquid | ACETYLCYSTEINE 200 MG | Cancelled Post Market |
| 02094738 | PARVOLEX LIQ IV 200MG/ML | BIONICHE PHARMA (CANADA) LTD | Liquid | ACETYLCYSTEINE 200 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 28444 | 2022-06-21 | Abbreviated New Drug Submission (ANDS) | Administrative: Merger/Buy-out |
| 26578 | 2021-09-01 | Abbreviated New Drug Submission (ANDS) | Administrative: Change in Product Ownership.Update Labelling |
| 18791 | 2016-12-19 | Abbreviated 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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