Approval · Notice of Compliance 12415 · 2011
FLUDARA: Notice of Compliance 12415
Issued June 8, 2011
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
- 12415
- Date
- June 8, 2011
- Company
- Genzyme Canada Inc
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Removal of a dosage form and indication in its entirety (Fludara IV) and removal of package size (Fludara oral tablets 100s)
- Therapeutic class
- Antineoplastic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FLUDARA | Not yet assigned | — |
Medicinal ingredients
- FLUDARABINE PHOSPHATE 10 MG per TAB
- FLUDARABINE PHOSPHATE SODIUM 50 MG per VIAL