Approval · Notice of Compliance 13910 · 2012
TEVA-RISPERIDONE: Notice of Compliance 13910
Issued November 28, 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
- 13910
- Date
- November 28, 2012
- Company
- Teva Canada LimitedToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Manufacturer and product name change
- Therapeutic class
- Antipsychotic agent
- Canadian reference product
- RISPERDAL (Janssen-Ortho Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TEVA-RISPERIDONE | 02282690 | Marketed |
| TEVA-RISPERIDONE | 02264188 | Dormant |
| TEVA-RISPERIDONE | 02264196 | Marketed |
| TEVA-RISPERIDONE | 02264218 | Marketed |
| TEVA-RISPERIDONE | 02264226 | Marketed |
| TEVA-RISPERIDONE | 02264234 | 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