Approval · Notice of Compliance 31618 · 2023
FLUDARA: Notice of Compliance 31618
Issued September 14, 2023
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
- 31618
- Date
- September 14, 2023
- Company
- Sanofi-Aventis Canada Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Product Monograph reformatted to the Master Template. Updates to the Product Monograph
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FLUDARA | Not yet assigned | — |
Medicinal ingredients
- FLUDARABINE PHOSPHATE 10 MG per TAB