Approval · Notice of Compliance 27287 · 2021
TARO-RISPERIDONE: Notice of Compliance 27287
Issued December 23, 2021
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
- 27287
- Date
- December 23, 2021
- Company
- Sun Pharma Canada Inc.Brampton, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Labelling Only
- Reason
- Updated product monograph and labelling materials. Administrative: Manufacturer and Product Name Change
- Canadian reference product
- RISPERDAL (Janssen-Ortho Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TARO-RISPERIDONE | 02328305 | Dormant |
| TARO-RISPERIDONE | 02328313 | Dormant |
| TARO-RISPERIDONE | 02328321 | Dormant |
| TARO-RISPERIDONE | 02328348 | Dormant |
| TARO-RISPERIDONE | 02328364 | Dormant |
| TARO-RISPERIDONE | 02328372 | Dormant |
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