Approval · Notice of Compliance 14595 · 2013
LATUDA: Notice of Compliance 14595
Issued July 25, 2013
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
- 14595
- Date
- July 25, 2013
- Company
- Sunovion Pharmaceuticals Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revision to the indication; management of the manifestations of schizophrenia
- Therapeutic class
- Antipsychotic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LATUDA | Not yet assigned | — |
Medicinal ingredients
- LURASIDONE HYDROCHLORIDE 40 MG per TAB
- LURASIDONE HYDROCHLORIDE 80 MG per TAB
- LURASIDONE HYDROCHLORIDE 120 MG per TAB