RISPERDAL M-TAB DIN 02268094
Health Canada record
| Active ingredient(s) | RISPERIDONE 4 MG |
|---|---|
| Dosage form | Tablet (Orally-Disintegrating) |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N05AX08 RISPERIDONE |
| Original market date | 20-Jun-2005 |
| Current status date | 28-Sep-2016 |
| Source | Health Canada DPD |
Establishment licence of the holder
Janssen Inc — licence 100239, currently licensed, last inspection rating C (2026-03-09).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing RISPERIDONE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02282151 | APO-RISPERIDONE | APOTEX INC | Tablet | RISPERIDONE 3.0 MG | Marketed |
| 02282119 | APO-RISPERIDONE | APOTEX INC | Tablet | RISPERIDONE 0.25 MG | Marketed |
| 02282127 | APO-RISPERIDONE | APOTEX INC | Tablet | RISPERIDONE 0.50 MG | Marketed |
| 02282135 | APO-RISPERIDONE | APOTEX INC | Tablet | RISPERIDONE 1.0 MG | Marketed |
| 02282143 | APO-RISPERIDONE | APOTEX INC | Tablet | RISPERIDONE 2.0 MG | Marketed |
| 02252015 | PMS-RISPERIDONE | PHARMASCIENCE INC | Tablet | RISPERIDONE 0.5 MG | Marketed |
| 02252007 | PMS-RISPERIDONE | PHARMASCIENCE INC | Tablet | RISPERIDONE 0.25 MG | Marketed |
| 02252066 | PMS-RISPERIDONE | PHARMASCIENCE INC | Tablet | RISPERIDONE 4.0 MG | Marketed |
| 02252058 | PMS-RISPERIDONE | PHARMASCIENCE INC | Tablet | RISPERIDONE 3.0 MG | Marketed |
| 02252031 | PMS-RISPERIDONE | PHARMASCIENCE INC | Tablet | RISPERIDONE 2.0 MG | Marketed |
| 02252023 | PMS-RISPERIDONE | PHARMASCIENCE INC | Tablet | RISPERIDONE 1.0 MG | Marketed |
| 02255758 | RISPERDAL CONSTA | JANSSEN INC | Kit; Powder For Suspension (Sustained-Release | RISPERIDONE 50 MG | Marketed |
| 02255707 | RISPERDAL CONSTA | JANSSEN INC | Powder For Suspension (Sustained-Release; Kit | RISPERIDONE 25 MG | Marketed |
| 02255723 | RISPERDAL CONSTA | JANSSEN INC | Kit; Powder For Suspension (Sustained-Release | RISPERIDONE 37.5 MG | Marketed |
| 02279827 | SANDOZ RISPERIDONE | SANDOZ CANADA INCORPORATED | Tablet | RISPERIDONE 3 MG | Marketed |
| 02279835 | SANDOZ RISPERIDONE | SANDOZ CANADA INCORPORATED | Tablet | RISPERIDONE 4 MG | Marketed |
| 02279800 | SANDOZ RISPERIDONE | SANDOZ CANADA INCORPORATED | Tablet | RISPERIDONE 1 MG | Marketed |
| 02279819 | SANDOZ RISPERIDONE | SANDOZ CANADA INCORPORATED | Tablet | RISPERIDONE 2 MG | Marketed |
| 02264218 | TEVA-RISPERIDONE | TEVA CANADA LIMITED | Tablet | RISPERIDONE 2 MG | Marketed |
| 02264234 | TEVA-RISPERIDONE | TEVA CANADA LIMITED | Tablet | RISPERIDONE 4 MG | Marketed |
| 02264196 | TEVA-RISPERIDONE | TEVA CANADA LIMITED | Tablet | RISPERIDONE 1 MG | Marketed |
| 02264226 | TEVA-RISPERIDONE | TEVA CANADA LIMITED | Tablet | RISPERIDONE 3 MG | Marketed |
| 02278456 | DOM-RISPERIDONE | DOMINION PHARMACAL | Tablet | RISPERIDONE 1.0 MG | Cancelled Post Market |
| 02278480 | DOM-RISPERIDONE | DOMINION PHARMACAL | Tablet | RISPERIDONE 4.0 MG | Cancelled Post Market |
| 02278464 | DOM-RISPERIDONE | DOMINION PHARMACAL | Tablet | RISPERIDONE 2.0 MG | Cancelled Post Market |
| 02278472 | DOM-RISPERIDONE | DOMINION PHARMACAL | Tablet | RISPERIDONE 3.0 MG | Cancelled Post Market |
| 02278421 | DOM-RISPERIDONE | DOMINION PHARMACAL | Tablet | RISPERIDONE 0.25 MG | Cancelled Post Market |
| 02278448 | DOM-RISPERIDONE | DOMINION PHARMACAL | Tablet | RISPERIDONE 0.5 MG | Cancelled Post Market |
| 02258471 | PHL-RISPERIDONE | PHARMEL INC | Tablet | RISPERIDONE 3.0 MG | Cancelled Post Market |
| 02258439 | PHL-RISPERIDONE | PHARMEL INC | Tablet | RISPERIDONE 0.25 MG | Cancelled Post Market |
| 02258447 | PHL-RISPERIDONE | PHARMEL INC | Tablet | RISPERIDONE 0.5 MG | Cancelled Post Market |
| 02258455 | PHL-RISPERIDONE | PHARMEL INC | Tablet | RISPERIDONE 1.0 MG | Cancelled Post Market |
| 02258463 | PHL-RISPERIDONE | PHARMEL INC | Tablet | RISPERIDONE 2.0 MG | Cancelled Post Market |
| 02258498 | PHL-RISPERIDONE | PHARMEL INC | Tablet | RISPERIDONE 4.0 MG | Cancelled Post Market |
| 02280914 | RAN-RISPERIDONE | RANBAXY PHARMACEUTICALS CANADA INC. | Tablet | RISPERIDONE 0.5 MG | Cancelled Post Market |
| 02280906 | RAN-RISPERIDONE | RANBAXY PHARMACEUTICALS CANADA INC. | Tablet | RISPERIDONE 0.25 MG | Cancelled Post Market |
| 02280957 | RAN-RISPERIDONE | RANBAXY PHARMACEUTICALS CANADA INC. | Tablet | RISPERIDONE 4 MG | Cancelled Post Market |
| 02280949 | RAN-RISPERIDONE | RANBAXY PHARMACEUTICALS CANADA INC. | Tablet | RISPERIDONE 3 MG | Cancelled Post Market |
| 02280930 | RAN-RISPERIDONE | RANBAXY PHARMACEUTICALS CANADA INC. | Tablet | RISPERIDONE 2 MG | Cancelled Post Market |
| 02280922 | RAN-RISPERIDONE | RANBAXY PHARMACEUTICALS CANADA INC. | Tablet | RISPERIDONE 1 MG | Cancelled Post Market |
| 02264757 | RATIO-RISPERIDONE | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet | RISPERIDONE 0.25 MG | Cancelled Post Market |
| 02264811 | RATIO-RISPERIDONE | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet | RISPERIDONE 4.0 MG | Cancelled Post Market |
| 02264803 | RATIO-RISPERIDONE | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet | RISPERIDONE 3.0 MG | Cancelled Post Market |
| 02264781 | RATIO-RISPERIDONE | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet | RISPERIDONE 2.0 MG | Cancelled Post Market |
| 02264773 | RATIO-RISPERIDONE | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet | RISPERIDONE 1.0 MG | Cancelled Post Market |
| 02264765 | RATIO-RISPERIDONE | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet | RISPERIDONE 0.5 MG | Cancelled Post Market |
| 02025299 | RISPERDAL | JANSSEN INC | Tablet | RISPERIDONE 2 MG | Cancelled Post Market |
| 02025280 | RISPERDAL | JANSSEN INC | Tablet | RISPERIDONE 1 MG | Cancelled Post Market |
| 02240552 | RISPERDAL | JANSSEN INC | Tablet | RISPERIDONE 0.5 MG | Cancelled Post Market |
| 02240551 | RISPERDAL | JANSSEN INC | Tablet | RISPERIDONE 0.25 MG | Cancelled Post Market |
| 02230455 | RISPERDAL | JANSSEN INC | Tablet | RISPERIDONE 5 MG | Cancelled Post Market |
| 02025310 | RISPERDAL | JANSSEN INC | Tablet | RISPERIDONE 4 MG | Cancelled Post Market |
| 02025302 | RISPERDAL | JANSSEN INC | Tablet | RISPERIDONE 3 MG | Cancelled Post Market |
| 02247704 | RISPERDAL M-TAB | JANSSEN INC | Tablet (Orally-Disintegrating) | RISPERIDONE 0.5 MG | Cancelled Post Market |
| 02268086 | RISPERDAL M-TAB | JANSSEN INC | Tablet (Orally-Disintegrating) | RISPERIDONE 3 MG | Cancelled Post Market |
| 02247705 | RISPERDAL M-TAB | JANSSEN INC | Tablet (Orally-Disintegrating) | RISPERIDONE 1 MG | Cancelled Post Market |
| 02247706 | RISPERDAL M-TAB | JANSSEN INC | Tablet (Orally-Disintegrating) | RISPERIDONE 2 MG | Cancelled Post Market |
| 02279509 | SANDOZ RISPERIDONE | SANDOZ CANADA INCORPORATED | Tablet | RISPERIDONE 0.25 MG | Cancelled Post Market |
| 02279495 | SANDOZ RISPERIDONE | SANDOZ CANADA INCORPORATED | Tablet | RISPERIDONE 0.5 MG | Cancelled Post Market |
| 02264188 | TEVA-RISPERIDONE | TEVA CANADA LIMITED | Tablet | RISPERIDONE 0.5 MG | Dormant |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 16312 | 2014-11-12 | Supplement to a New Drug Submission (SNDS) | RESTRICT INDICATION TO THOSE PATIENTS WITH SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE UNRESPONSIVE TO NON-PHARMACOLOGICAL APPROACHES AND WHERE THERE IS A RISK OF HARM TO OTHERS |
| 7002 | 2005-05-31 | Supplement to a New Drug Submission (SNDS) | TWO ADDITIONAL STRENGTHS AND REFORMULATION OF THE 2MG TABLET |
International API supply for RISPERIDONE
16 valid EDQM Certificates of Suitability from 16 holders. 20 active FDA Drug Master Files.
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