Approval · Notice of Compliance 25533 · 2021
ACETYLCYSTEINE SOLUTION: Notice of Compliance 25533
Issued March 26, 2021
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 25533
- Date
- March 26, 2021
- Company
- Sandoz Canada Inc.Saint-Hubert, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Change in recommended dose or dosing range. change in specification. change in shelf life for the drug product. change in post-approval stability protocol or stability commitment
- Canadian reference product
- MUCOMYST (Roberts Pharmaceutical Canada Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ACETYLCYSTEINE SOLUTION | Not yet assigned | — |
Medicinal ingredients
- ACETYLCYSTEINE 200 MG per VIAL