Approval · Notice of Compliance 10584 · 2009
FXT 40: Notice of Compliance 10584
Issued September 11, 2009
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
- 10584
- Date
- September 11, 2009
- Company
- Sepracor Pharmaceuticals IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Manufacturer name change
- Therapeutic class
- Antidepressant/Antiobsessional/Antibulimic
- Canadian reference product
- PROZAC (Eli Lilly Canada Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FXT 40 | 02245283 | Cancelled Post Market |
Medicinal ingredients
- FLUOXETINE HYDROCHLORIDE 40 MG per TAB