Approval · Notice of Compliance 28300 · 2022
FLUVOXAMINE TABLETS: Notice of Compliance 28300
Issued June 1, 2022
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
- 28300
- Date
- June 1, 2022
- Company
- Ivax Pharmaceuticals IncorporatedToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Reactivate the sponsor¿s existing DINs and to update the Product Monograph and Labelling
- Canadian reference product
- LUVOX (Solvay Pharma Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FLUVOXAMINE TABLETS | 02246822 | Cancelled Pre Market |
| FLUVOXAMINE TABLETS | 02246823 | Cancelled Pre Market |
Medicinal ingredients
- FLUVOXAMINE MALEATE 50 MG per TAB
- FLUVOXAMINE MALEATE 100 MG per TAB