Approval · Notice of Compliance 9449 · 2008
PHL-RISPERIDONE ODT: Notice of Compliance 9449
Issued March 28, 2008
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
- 9449
- Date
- March 28, 2008
- Company
- Pharmel Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Admin
- Reason
- New dosage form - orally disintegrating tablet
- Therapeutic class
- Antipsychotic agent
- Canadian reference product
- RISPERDAL M-TAB (Janssen-Ortho Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PHL-RISPERIDONE ODT | 02294435 | Cancelled Pre Market |
| PHL-RISPERIDONE ODT | 02294443 | Cancelled Pre Market |
| PHL-RISPERIDONE ODT | 02294451 | Cancelled Pre Market |
Medicinal ingredients
- RISPERIDONE 0.5 MG per TAB
- RISPERIDONE 1 MG per TAB
- RISPERIDONE 2 MG per TAB