APO-METHYLPHENIDATE CR DIN 02559455
Health Canada record
| Active ingredient(s) | METHYLPHENIDATE HYDROCHLORIDE 40 MG |
|---|---|
| Dosage form | Capsule (Extended-Release) |
| Route | Oral |
| Schedule | CONTROLLED DRUGS (CDSA III) |
| Class | Human |
| ATC | N06BA04 METHYLPHENIDATE |
| Original market date | |
| Current status date | 15-Jul-2025 |
| Source | Health Canada DPD |
Establishment licence of the holder
Apotex Inc — licence 100375, currently licensed, last inspection rating C (2026-04-21).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing METHYLPHENIDATE HYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02266687 | AA-METHYLPHENIDATE SR | AA PHARMA INC | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 20 MG | Marketed |
| 02441950 | ACT METHYLPHENIDATE ER | TEVA CANADA LIMITED | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 36 MG | Marketed |
| 02441969 | ACT METHYLPHENIDATE ER | TEVA CANADA LIMITED | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 54 MG | Marketed |
| 02441942 | ACT METHYLPHENIDATE ER | TEVA CANADA LIMITED | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 27 MG | Marketed |
| 02441934 | ACT METHYLPHENIDATE ER | TEVA CANADA LIMITED | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 18 MG | Marketed |
| 02273950 | APO-METHYLPHENIDATE | APOTEX INC | Tablet | METHYLPHENIDATE HYDROCHLORIDE 5 MG | Marketed |
| 02249324 | APO-METHYLPHENIDATE | APOTEX INC | Tablet | METHYLPHENIDATE HYDROCHLORIDE 10 MG | Marketed |
| 02249332 | APO-METHYLPHENIDATE | APOTEX INC | Tablet | METHYLPHENIDATE HYDROCHLORIDE 20 MG | Marketed |
| 02452758 | APO-METHYLPHENIDATE ER | APOTEX INC | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 27 MG | Marketed |
| 02452766 | APO-METHYLPHENIDATE ER | APOTEX INC | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 36 MG | Marketed |
| 02452731 | APO-METHYLPHENIDATE ER | APOTEX INC | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 18 MG | Marketed |
| 02330377 | APO-METHYLPHENIDATE ER | APOTEX INC | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 54 MG | Marketed |
| 02277174 | BIPHENTIN | ELVIUM LIFE SCIENCES | Capsule (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 30 MG | Marketed |
| 02277182 | BIPHENTIN | ELVIUM LIFE SCIENCES | Capsule (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 40 MG | Marketed |
| 02277166 | BIPHENTIN | ELVIUM LIFE SCIENCES | Capsule (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 10 MG | Marketed |
| 02277190 | BIPHENTIN | ELVIUM LIFE SCIENCES | Capsule (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 50 MG | Marketed |
| 02277212 | BIPHENTIN | ELVIUM LIFE SCIENCES | Capsule (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 80 MG | Marketed |
| 02277204 | BIPHENTIN | ELVIUM LIFE SCIENCES | Capsule (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 60 MG | Marketed |
| 02277158 | BIPHENTIN | ELVIUM LIFE SCIENCES | Capsule (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 20 MG | Marketed |
| 02277131 | BIPHENTIN | ELVIUM LIFE SCIENCES | Capsule (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 15 MG | Marketed |
| 02247734 | CONCERTA | JANSSEN INC | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 54 MG | Marketed |
| 02247732 | CONCERTA | JANSSEN INC | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 18 MG | Marketed |
| 02247733 | CONCERTA | JANSSEN INC | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 36 MG | Marketed |
| 02250241 | CONCERTA | JANSSEN INC | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 27 MG | Marketed |
| 02470292 | FOQUEST | ELVIUM LIFE SCIENCES | Capsule (Controlled-Release) | METHYLPHENIDATE HYDROCHLORIDE 25 MG | Marketed |
| 00585009 | PMS-METHYLPHENIDATE | PHARMASCIENCE INC | Tablet | METHYLPHENIDATE HYDROCHLORIDE 20 MG | Marketed |
| 00584991 | PMS-METHYLPHENIDATE | PHARMASCIENCE INC | Tablet | METHYLPHENIDATE HYDROCHLORIDE 10 MG | Marketed |
| 02234749 | PMS-METHYLPHENIDATE | PHARMASCIENCE INC | Tablet | METHYLPHENIDATE HYDROCHLORIDE 5 MG | Marketed |
| 02326248 | METHYLPHENIDATE | PRO DOC LIMITEE | Tablet | METHYLPHENIDATE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02326256 | METHYLPHENIDATE | PRO DOC LIMITEE | Tablet | METHYLPHENIDATE HYDROCHLORIDE 20 MG | Cancelled Post Market |
| 02326221 | METHYLPHENIDATE | PRO DOC LIMITEE | Tablet | METHYLPHENIDATE HYDROCHLORIDE 5 MG | Cancelled Post Market |
| 00422975 | METHYLPHENIDATE TAB 10MG | TECHNILAB PHARMA INC. | Tablet | METHYLPHENIDATE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 00422983 | METHYLPHENIDATE TAB 20MG | TECHNILAB PHARMA INC. | Tablet | METHYLPHENIDATE HYDROCHLORIDE 20 MG | Cancelled Post Market |
| 02274299 | NOVO-METHYLPHENIDATE | NOVOPHARM LIMITED | Tablet | METHYLPHENIDATE HYDROCHLORIDE 10.00 MG | Cancelled Pre Market |
| 02274280 | NOVO-METHYLPHENIDATE | NOVOPHARM LIMITED | Tablet | METHYLPHENIDATE HYDROCHLORIDE 5.00 MG | Cancelled Pre Market |
| 02274302 | NOVO-METHYLPHENIDATE | NOVOPHARM LIMITED | Tablet | METHYLPHENIDATE HYDROCHLORIDE 20.00 MG | Cancelled Pre Market |
| 02346230 | NTP-METHYLPHENIDATE ER-C | NT PHARMA CANADA LTD | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 36 MG | Cancelled Pre Market |
| 02346222 | NTP-METHYLPHENIDATE ER-C | NT PHARMA CANADA LTD | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 27 MG | Cancelled Pre Market |
| 02346214 | NTP-METHYLPHENIDATE ER-C | NT PHARMA CANADA LTD | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 18 MG | Cancelled Pre Market |
| 02346249 | NTP-METHYLPHENIDATE ER-C | NT PHARMA CANADA LTD | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 54 MG | Cancelled Pre Market |
| 02246991 | PHL-METHYLPHENIDATE | PHARMEL INC | Tablet | METHYLPHENIDATE HYDROCHLORIDE 5 MG | Cancelled Post Market |
| 02126486 | PHL-METHYLPHENIDATE | PHARMEL INC | Tablet | METHYLPHENIDATE HYDROCHLORIDE 20 MG | Cancelled Post Market |
| 02126494 | PHL-METHYLPHENIDATE | PHARMEL INC | Tablet | METHYLPHENIDATE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02413736 | PMS-METHYLPHENIDATE ER | PHARMASCIENCE INC | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 27 MG | Cancelled Post Market |
| 02413744 | PMS-METHYLPHENIDATE ER | PHARMASCIENCE INC | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 36 MG | Cancelled Post Market |
| 02413752 | PMS-METHYLPHENIDATE ER | PHARMASCIENCE INC | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 54 MG | Cancelled Post Market |
| 02413728 | PMS-METHYLPHENIDATE ER | PHARMASCIENCE INC | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 18 MG | Cancelled Post Market |
| 02247364 | RATIO-METHYLPHENIDATE | TEVA CANADA LIMITED | Tablet | METHYLPHENIDATE HYDROCHLORIDE 5 MG | Cancelled Post Market |
| 02230322 | RATIO-METHYLPHENIDATE | TEVA CANADA LIMITED | Tablet | METHYLPHENIDATE HYDROCHLORIDE 20 MG | Cancelled Post Market |
| 02230321 | RATIO-METHYLPHENIDATE | TEVA CANADA LIMITED | Tablet | METHYLPHENIDATE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 00005606 | RITALIN 10MG | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet | METHYLPHENIDATE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 00005614 | RITALIN 20MG | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet | METHYLPHENIDATE HYDROCHLORIDE 20 MG | Cancelled Post Market |
| 00632775 | RITALIN-SR TAB 20MG | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 20 MG | Cancelled Post Market |
| 02455846 | SANDOZ METHYLPHENIDATE | SANDOZ CANADA INCORPORATED | Tablet | METHYLPHENIDATE HYDROCHLORIDE 10 MG | Cancelled Pre Market |
| 02455854 | SANDOZ METHYLPHENIDATE | SANDOZ CANADA INCORPORATED | Tablet | METHYLPHENIDATE HYDROCHLORIDE 20 MG | Cancelled Pre Market |
| 02320312 | SANDOZ METHYLPHENIDATE SR | SANDOZ CANADA INCORPORATED | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 20 MG | Cancelled Post Market |
| 02315092 | TEVA-METHYLPHENIDATE ER-C | TEVA CANADA LIMITED | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 54 MG | Cancelled Post Market |
| 02315076 | TEVA-METHYLPHENIDATE ER-C | TEVA CANADA LIMITED | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 27 MG | Cancelled Post Market |
| 02315084 | TEVA-METHYLPHENIDATE ER-C | TEVA CANADA LIMITED | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 36 MG | Cancelled Post Market |
| 02315068 | TEVA-METHYLPHENIDATE ER-C | TEVA CANADA LIMITED | Tablet (Extended-Release) | METHYLPHENIDATE HYDROCHLORIDE 18 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 35665 | 2025-07-15 | Abbreviated New Drug Submission (ANDS) |
International API supply for METHYLPHENIDATE HYDROCHLORIDE
14 valid EDQM Certificates of Suitability from 14 holders. 20 active FDA Drug Master Files.
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