Approval · Notice of Compliance 503 · 2002
FLUDARA: Notice of Compliance 503
Issued August 20, 2002
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
- 503
- Date
- August 20, 2002
- Company
- Berlex Canada Inc.Pointe-Claire, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New dosage form: 10mg tablets
- Therapeutic class
- Antineoplastic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FLUDARA | 02246226 | Marketed |
Medicinal ingredients
- FLUDARABINE PHOSPHATE 10 MG per TAB