Approval · Notice of Compliance 14325 · 2013
FLUDARA: Notice of Compliance 14325
Issued April 30, 2013
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
- 14325
- Date
- April 30, 2013
- Company
- Sanofi-Aventis Canada Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Manufacturer name change
- Therapeutic class
- Antineoplastic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FLUDARA | 02246226 | Marketed |
Medicinal ingredients
- FLUDARABINE PHOSPHATE 10 MG per TAB