Drug · DIN 01989537
FLUDARA
No: no longer authorized
The company stopped selling it and its DIN was cancelled. A cancellation is most often a business decision; the record does not say why.
Status Cancelled Post Market since March 31, 2011; first marketed December 31, 1993.
- Drug Identification Number (DIN)
- 01989537
- Company (DIN owner)
- Sanofi Genzyme, A Division Of Sanofi-Aventis Canada IncToronto, Ontario, Canada
- Schedule
- Prescription
- Dosage form
- Powder For Solution
- Route
- Intravenous
- Therapeutic class (ATC)
- Fludarabine L01BB05
- Class
- Human
- Record last updated
- March 22, 2025
Active ingredients
As listed in the Drug Product Database.
| Ingredient | Strength | Per |
|---|---|---|
| FLUDARABINE PHOSPHATE (FLUDARABINE PHOSPHATE SODIUM) | 50 MG | VIAL |
Notices of Compliance
Health Canada approvals that name this DIN.
- August 11, 2009: NOC 10496New Drug Submission (NDS) · Manufacturer name change
- March 20, 2007: NOC 8661New Drug Submission (NDS) · Manufacturer name change
- October 30, 2001: NOC 2256Supplement to a New Drug Submission (SNDS) · New indication: for the use in the treatment of low-grade non-hodgkin's lymphoma (lg-nhl) in patients who have failed other conventional treatment
Other DINs named FLUDARA
- DIN 02246226 · Marketed