Approval · Notice of Compliance 33441 · 2024
LURASIDONE: Notice of Compliance 33441
Issued June 13, 2024
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
- 33441
- Date
- June 13, 2024
- Company
- Sanis Health Inc.Brampton, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Administrative: Licensing Agreement Between Two Manufacturers
- Canadian reference product
- LATUDA (Sunovion Pharmaceuticals Canada Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LURASIDONE | 02548585 | Marketed |
| LURASIDONE | 02548593 | Marketed |
| LURASIDONE | 02548607 | Marketed |
| LURASIDONE | 02548615 | Marketed |
| LURASIDONE | 02548623 | Approved |
Medicinal ingredients
- LURASIDONE HYDROCHLORIDE 20 MG per TAB
- LURASIDONE HYDROCHLORIDE 40 MG per TAB
- LURASIDONE HYDROCHLORIDE 60 MG per TAB
- LURASIDONE HYDROCHLORIDE 80 MG per TAB
- LURASIDONE HYDROCHLORIDE 120 MG per TAB