Approval · Notice of Compliance 11201 · 2010
SERTRALINE: Notice of Compliance 11201
Issued March 30, 2010
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
- 11201
- Date
- March 30, 2010
- Company
- Sanis Health Inc.Brampton, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Manufacturer name change
- Therapeutic class
- Antidepressant / Antipanic / Antiobessional agent
- Canadian reference product
- ZOLOFT (Pfizer Canada Ulc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SERTRALINE | 02284804 | Cancelled Post Market |
| SERTRALINE | 02284812 | Cancelled Post Market |
| SERTRALINE | 02284820 | Cancelled Post Market |
Medicinal ingredients
- SERTRALINE HYDROCHLORIDE 25 MG per CAP
- SERTRALINE HYDROCHLORIDE 50 MG per CAP
- SERTRALINE HYDROCHLORIDE 100 MG per CAP