Approval · Notice of Compliance 552 · 2002
FLUOXETINE: Notice of Compliance 552
Issued March 11, 2002
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
- 552
- Date
- March 11, 2002
- Company
- Pharmel Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Alternate formulation, manufacturing procedure and manufacturing site
- Therapeutic class
- Antidepressant, antiobsessional, antibulimic
- Canadian reference product
- PROZAC (Eli Lilly Canada Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FLUOXETINE | 02223481 | Cancelled Post Market |
| FLUOXETINE | 02223503 | Cancelled Post Market |
Medicinal ingredients
- FLUOXETINE HYDROCHLORIDE 10 MG per CAP
- FLUOXETINE HYDROCHLORIDE 20 MG per CAP