Approval · Notice of Compliance 9756 · 2008
PRO-FLUOXETINE: Notice of Compliance 9756
Issued September 2, 2008
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
- 9756
- Date
- September 2, 2008
- Company
- Pro Doc LimiteeLaval, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- New manufacturer and product name
- Therapeutic class
- Antidepressant / antiobsessional / antibulimic
- Canadian reference product
- PROZAC (Eli Lilly Canada Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PRO-FLUOXETINE | Not yet assigned | — |
Medicinal ingredients
- FLUOXETINE HYDROCHLORIDE 10 MG per CAP
- FLUOXETINE HYDROCHLORIDE 20 MG per CAP