Approval · Notice of Compliance 13323 · 2012
FLUOXETINE: Notice of Compliance 13323
Issued May 31, 2012
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
- 13323
- Date
- May 31, 2012
- Company
- Sivem Pharmaceuticals UlcSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Manufacturer name change
- Therapeutic class
- Antidepressantl Antiobsessional; Antibulimic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FLUOXETINE | 02374447 | Marketed |
| FLUOXETINE | 02374455 | Marketed |
Medicinal ingredients
- FLUOXETINE HYDROCHLORIDE 10 MG per CAP
- FLUOXETINE HYDROCHLORIDE 20 MG per CAP