Approval · Notice of Compliance 8111 · 2006
APO-RISPERIDONE: Notice of Compliance 8111
Issued July 5, 2006
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
- 8111
- Date
- July 5, 2006
- Company
- Apotex Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Other
- Therapeutic class
- Antipsychotic agent
- Canadian reference product
- RISPERDAL (Janssen-Ortho Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| APO-RISPERIDONE | 02282119 | Marketed |
| APO-RISPERIDONE | 02282127 | Marketed |
| APO-RISPERIDONE | 02282135 | Marketed |
| APO-RISPERIDONE | 02282143 | Marketed |
| APO-RISPERIDONE | 02282151 | Marketed |
| APO-RISPERIDONE | 02282178 | Marketed |
Medicinal ingredients
- RISPERIDONE 0.25 MG per TAB
- RISPERIDONE 0.5 MG per TAB
- RISPERIDONE 1 MG per TAB
- RISPERIDONE 2 MG per TAB
- RISPERIDONE 3 MG per TAB
- RISPERIDONE 4 MG per TAB