Approval · Notice of Compliance 894 · 2003
FLUOXETINE: Notice of Compliance 894
Issued May 8, 2003
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
- 894
- Date
- May 8, 2003
- Company
- Prempharm Inc.Etobicoke, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Therapeutic class
- Antidepressant, antiobsessional, antibulimic
- Canadian reference product
- PROZAC (Eli Lilly Canada Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FLUOXETINE | 02247528 | — |
| FLUOXETINE | 02247529 | — |
Medicinal ingredients
- FLUOXETINE HYDROCHLORIDE 10 MG per CAP
- FLUOXETINE HYDROCHLORIDE 20 MG per CAP