Approval · Notice of Compliance 12576 · 2011
AG-RISPERIDONE: Notice of Compliance 12576
Issued August 22, 2011
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
- 12576
- Date
- August 22, 2011
- Company
- Angita Pharma Inc.Boucherville, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- New Manufacturer and Product Name
- Therapeutic class
- Antipsychotic Agent
- Canadian reference product
- RISPERDAL (Janssen-Ortho Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| AG-RISPERIDONE | 02369079 | Dormant |
| AG-RISPERIDONE | 02369087 | Dormant |
| AG-RISPERIDONE | 02369095 | Dormant |
| AG-RISPERIDONE | 02369117 | Dormant |
| AG-RISPERIDONE | 02369125 | Dormant |
| AG-RISPERIDONE | 02369133 | 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