Approval · Notice of Compliance 8661 · 2007
FLUDARA: Notice of Compliance 8661
Issued March 20, 2007
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
- 8661
- Date
- March 20, 2007
- Company
- Bayer Inc.Elkhart, Indiana, United States
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Manufacturer name change
- Therapeutic class
- Antineoplastic
Products in this notice
Medicinal ingredients
- FLUDARABINE PHOSPHATE SODIUM 50 MG per VIAL
- FLUDARABINE PHOSPHATE 10 MG per TAB