Approval · Notice of Compliance 9832 · 2008
FLUDARA: Notice of Compliance 9832
Issued October 15, 2008
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
- 9832
- Date
- October 15, 2008
- Company
- Bayer Inc.Elkhart, Indiana, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revisions to the product monograph
- Therapeutic class
- Antineoplastic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FLUDARA | Not yet assigned | — |
Medicinal ingredients
- FLUDARABINE PHOSPHATE SODIUM 50 MG per VIAL
- FLUDARABINE PHOSPHATE 10 MG per TAB