Approval · Notice of Compliance 557 · 2002
FXT 10: Notice of Compliance 557
Issued January 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
- 557
- Date
- January 11, 2002
- Company
- Oryx Pharmaceuticals Inc.
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Manufacturer and product name change
- Therapeutic class
- Antidepressant, antiobsessional, antibulimic
- Canadian reference product
- PROZAC (Eli Lilly Canada Inc)
Products in this notice
Medicinal ingredients
- FLUOXETINE HYDROCHLORIDE 10 MG per CAP
- FLUOXETINE HYDROCHLORIDE 20 MG per CAP
- FLUOXETINE HYDROCHLORIDE 40 MG per CAP