NRA-RISPERIDONE DIN 02566044
Health Canada record
| Active ingredient(s) | RISPERIDONE 2 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N05AX08 RISPERIDONE |
| Original market date | |
| Current status date | 24-Feb-2026 |
| Source | Health Canada DPD |
Establishment licence of the holder
Nora Pharma Inc — licence 3-002506, currently licensed, last inspection rating C (2022-11-29).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing RISPERIDONE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02282135 | APO-RISPERIDONE | APOTEX INC | Tablet | RISPERIDONE 1.0 MG | Marketed |
| 02282127 | APO-RISPERIDONE | APOTEX INC | Tablet | RISPERIDONE 0.50 MG | Marketed |
| 02282119 | APO-RISPERIDONE | APOTEX INC | Tablet | RISPERIDONE 0.25 MG | Marketed |
| 02282151 | APO-RISPERIDONE | APOTEX INC | Tablet | RISPERIDONE 3.0 MG | Marketed |
| 02282178 | APO-RISPERIDONE | APOTEX INC | Tablet | RISPERIDONE 4.0 MG | Marketed |
| 02282143 | APO-RISPERIDONE | APOTEX INC | Tablet | RISPERIDONE 2.0 MG | Marketed |
| 02359081 | IPG-RISPERIDONE | MARCAN PHARMACEUTICALS INC | Tablet | RISPERIDONE 2 MG | Approved |
| 02359065 | IPG-RISPERIDONE | MARCAN PHARMACEUTICALS INC | Tablet | RISPERIDONE 0.5 MG | Approved |
| 02563371 | JAMP RISPERIDONE TABLETS | JAMP PHARMA CORPORATION | Tablet | RISPERIDONE 4 MG | Approved |
| 02563355 | JAMP RISPERIDONE TABLETS | JAMP PHARMA CORPORATION | Tablet | RISPERIDONE 2 MG | Approved |
| 02563339 | JAMP RISPERIDONE TABLETS | JAMP PHARMA CORPORATION | Tablet | RISPERIDONE 0.5 MG | Marketed |
| 02563363 | JAMP RISPERIDONE TABLETS | JAMP PHARMA CORPORATION | Tablet | RISPERIDONE 3 MG | Marketed |
| 02563347 | JAMP RISPERIDONE TABLETS | JAMP PHARMA CORPORATION | Tablet | RISPERIDONE 1 MG | Marketed |
| 02563320 | JAMP RISPERIDONE TABLETS | JAMP PHARMA CORPORATION | Tablet | RISPERIDONE 0.25 MG | Marketed |
| 02359537 | JAMP-RISPERIDONE | JAMP PHARMA CORPORATION | Tablet | RISPERIDONE 0.50 MG | Marketed |
| 02359545 | JAMP-RISPERIDONE | JAMP PHARMA CORPORATION | Tablet | RISPERIDONE 1.0 MG | Marketed |
| 02359553 | JAMP-RISPERIDONE | JAMP PHARMA CORPORATION | Tablet | RISPERIDONE 2.0 MG | Marketed |
| 02566028 | NRA-RISPERIDONE | NORA PHARMA INC | Tablet | RISPERIDONE 0.5 MG | Approved |
| 02566060 | NRA-RISPERIDONE | NORA PHARMA INC | Tablet | RISPERIDONE 3 MG | Approved |
| 02566087 | NRA-RISPERIDONE | NORA PHARMA INC | Tablet | RISPERIDONE 4 MG | Approved |
| 02566036 | NRA-RISPERIDONE | NORA PHARMA INC | Tablet | RISPERIDONE 1 MG | Approved |
| 02565994 | NRA-RISPERIDONE | NORA PHARMA INC | Tablet | RISPERIDONE 0.25 MG | Approved |
| 02252031 | PMS-RISPERIDONE | PHARMASCIENCE INC | Tablet | RISPERIDONE 2.0 MG | Marketed |
| 02252066 | PMS-RISPERIDONE | PHARMASCIENCE INC | Tablet | RISPERIDONE 4.0 MG | Marketed |
| 02252023 | PMS-RISPERIDONE | PHARMASCIENCE INC | Tablet | RISPERIDONE 1.0 MG | Marketed |
| 02252058 | PMS-RISPERIDONE | PHARMASCIENCE INC | Tablet | RISPERIDONE 3.0 MG | Marketed |
| 02252007 | PMS-RISPERIDONE | PHARMASCIENCE INC | Tablet | RISPERIDONE 0.25 MG | Marketed |
| 02252015 | PMS-RISPERIDONE | PHARMASCIENCE INC | Tablet | RISPERIDONE 0.5 MG | Marketed |
| 02312727 | PRO-RISPERIDONE | PRO DOC LIMITEE | Tablet | RISPERIDONE 1.0 MG | Marketed |
| 02312751 | PRO-RISPERIDONE | PRO DOC LIMITEE | Tablet | RISPERIDONE 4.0 MG | Marketed |
| 02255723 | RISPERDAL CONSTA | JANSSEN INC | Kit; Powder For Suspension (Sustained-Release | RISPERIDONE 37.5 MG | Marketed |
| 02298465 | RISPERDAL CONSTA | JANSSEN INC | Powder For Suspension (Sustained-Release; Kit | RISPERIDONE 12.5 MG | Marketed |
| 02255707 | RISPERDAL CONSTA | JANSSEN INC | Powder For Suspension (Sustained-Release; Kit | RISPERIDONE 25 MG | Marketed |
| 02255758 | RISPERDAL CONSTA | JANSSEN INC | Kit; Powder For Suspension (Sustained-Release | RISPERIDONE 50 MG | Marketed |
| 02533944 | RISPERIDONE | SIVEM PHARMACEUTICALS ULC | Tablet | RISPERIDONE 2 MG | Marketed |
| 02533960 | RISPERIDONE | SIVEM PHARMACEUTICALS ULC | Tablet | RISPERIDONE 4 MG | Marketed |
| 02533928 | RISPERIDONE | SIVEM PHARMACEUTICALS ULC | Tablet | RISPERIDONE 0.5 MG | Marketed |
| 02533804 | RISPERIDONE | SIVEM PHARMACEUTICALS ULC | Tablet | RISPERIDONE 0.25 MG | Marketed |
| 02533952 | RISPERIDONE | SIVEM PHARMACEUTICALS ULC | Tablet | RISPERIDONE 3 MG | Marketed |
| 02533936 | RISPERIDONE | SIVEM PHARMACEUTICALS ULC | Tablet | RISPERIDONE 1 MG | Marketed |
| 02279819 | SANDOZ RISPERIDONE | SANDOZ CANADA INCORPORATED | Tablet | RISPERIDONE 2 MG | Marketed |
| 02303663 | SANDOZ RISPERIDONE | SANDOZ CANADA INCORPORATED | Tablet | RISPERIDONE 0.5 MG | Marketed |
| 02264196 | TEVA-RISPERIDONE | TEVA CANADA LIMITED | Tablet | RISPERIDONE 1 MG | Marketed |
| 02282690 | TEVA-RISPERIDONE | TEVA CANADA LIMITED | Tablet | RISPERIDONE 0.25 MG | Marketed |
| 02264226 | TEVA-RISPERIDONE | TEVA CANADA LIMITED | Tablet | RISPERIDONE 3 MG | Marketed |
| 02264234 | TEVA-RISPERIDONE | TEVA CANADA LIMITED | Tablet | RISPERIDONE 4 MG | Marketed |
| 02367238 | AVA-RISPERIDONE | AVANSTRA INC | Tablet | RISPERIDONE 3.0 MG | Cancelled Post Market |
| 02367246 | AVA-RISPERIDONE | AVANSTRA INC | Tablet | RISPERIDONE 4.0 MG | Cancelled Post Market |
| 02282291 | MYLAN-RISPERIDONE | MYLAN PHARMACEUTICALS ULC | Tablet | RISPERIDONE 4 MG | Cancelled Post Market |
| 02282275 | MYLAN-RISPERIDONE | MYLAN PHARMACEUTICALS ULC | Tablet | RISPERIDONE 2 MG | Cancelled Post Market |
| 02282259 | MYLAN-RISPERIDONE | MYLAN PHARMACEUTICALS ULC | Tablet | RISPERIDONE 0.50 MG | Cancelled Post Market |
| 02258463 | PHL-RISPERIDONE | PHARMEL INC | Tablet | RISPERIDONE 2.0 MG | Cancelled Post Market |
| 02258471 | PHL-RISPERIDONE | PHARMEL INC | Tablet | RISPERIDONE 3.0 MG | Cancelled Post Market |
| 02328364 | TARO-RISPERIDONE | SUN PHARMA CANADA INC | Tablet | RISPERIDONE 3 MG | Dormant |
| 02328372 | TARO-RISPERIDONE | SUN PHARMA CANADA INC | Tablet | RISPERIDONE 4 MG | Dormant |
| 02328305 | TARO-RISPERIDONE | SUN PHARMA CANADA INC | Tablet | RISPERIDONE 0.25 MG | Dormant |
| 02328321 | TARO-RISPERIDONE | SUN PHARMA CANADA INC | Tablet | RISPERIDONE 1 MG | Dormant |
| 02328313 | TARO-RISPERIDONE | SUN PHARMA CANADA INC | Tablet | RISPERIDONE 0.5 MG | Dormant |
| 02328348 | TARO-RISPERIDONE | SUN PHARMA CANADA INC | Tablet | RISPERIDONE 2 MG | Dormant |
| 02264188 | TEVA-RISPERIDONE | TEVA CANADA LIMITED | Tablet | RISPERIDONE 0.5 MG | Dormant |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 36962 | 2026-02-24 | Abbreviated New Drug Submission (ANDS) | Administrative: Licensing Agreement between two manufacturers |
International API supply for RISPERIDONE
16 valid EDQM Certificates of Suitability from 16 holders. 20 active FDA Drug Master Files.
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