Approval · Notice of Compliance 1794 · 1999
PROZAC: Notice of Compliance 1794
Issued August 6, 1999
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
- 1794
- Date
- August 6, 1999
- Company
- Eli Lilly Canada IncToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revised indication: provides long-term use in patients suffering from depresssion. product monograph revisions
- Therapeutic class
- Antidepressant/antiobsessional/antibulimic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PROZAC | Not yet assigned | — |
Medicinal ingredients
- FLUOXETINE HYDROCHLORIDE 10 MG per CAP
- FLUOXETINE HYDROCHLORIDE 20 MG per CAP
- FLUOXETINE HYDROCHLORIDE 20 MG per 5ML