Approval · Notice of Compliance 35161 · 2025
LEVODEXA: Notice of Compliance 35161
Issued April 10, 2025
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
- 35161
- Date
- April 10, 2025
- Company
- Xediton Pharmaceuticals Inc.Oakville, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Replacement of a manufacturing site and/or manufacturer involving production of the intermediate. Change in the manufacturing process for the drug substance. Change in the batch size for the drug substance
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LEVODEXA | Not yet assigned | — |
Medicinal ingredients
- DEXAMETHASONE 0.1 PER
- LEVOFLOXACIN 0.5 PER