APO-MYCOPHENOLATE MOFETIL DIN 02513714
Health Canada record
| Active ingredient(s) | MYCOPHENOLATE MOFETIL 250 MG |
|---|---|
| Dosage form | Capsule |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L04AA06 MYCOPHENOLIC ACID |
| Original market date | |
| Current status date | 19-Mar-2021 |
| 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 MYCOPHENOLATE MOFETIL
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02383780 | ACH-MYCOPHENOLATE | ACCORD HEALTHCARE INC | Capsule | MYCOPHENOLATE MOFETIL 250 MG | Marketed |
| 02378574 | ACH-MYCOPHENOLATE | ACCORD HEALTHCARE INC | Tablet | MYCOPHENOLATE MOFETIL 500 MG | Marketed |
| 02532735 | ACH-MYCOPHENOLATE | ACCORD HEALTHCARE INC | Powder For Suspension | MYCOPHENOLATE MOFETIL 200 MG | Approved |
| 02497182 | AG-MYCOPHENOLATE | ANGITA PHARMA INC. | Tablet | MYCOPHENOLATE MOFETIL 500 MG | Approved |
| 02513722 | APO-MYCOPHENOLATE MOFETIL | APOTEX INC | Tablet | MYCOPHENOLATE MOFETIL 500 MG | Approved |
| 02192748 | CELLCEPT | HOFFMANN-LA ROCHE LIMITED | Capsule | MYCOPHENOLATE MOFETIL 250 MG | Marketed |
| 02237484 | CELLCEPT | HOFFMANN-LA ROCHE LIMITED | Tablet | MYCOPHENOLATE MOFETIL 500 MG | Marketed |
| 02242145 | CELLCEPT | HOFFMANN-LA ROCHE LIMITED | Powder For Suspension | MYCOPHENOLATE MOFETIL 200 MG | Marketed |
| 02380382 | JAMP-MYCOPHENOLATE | JAMP PHARMA CORPORATION | Tablet | MYCOPHENOLATE MOFETIL 500 MG | Marketed |
| 02386399 | JAMP-MYCOPHENOLATE CAPSULES | JAMP PHARMA CORPORATION | Capsule | MYCOPHENOLATE MOFETIL 250 MG | Marketed |
| 02522233 | MAR-MYCOPHENOLATE MOFETIL | MARCAN PHARMACEUTICALS INC | Powder For Suspension | MYCOPHENOLATE MOFETIL 200 MG | Marketed |
| 02457377 | MYCOPHENOLATE MOFETIL | SANIS HEALTH INC | Tablet | MYCOPHENOLATE MOFETIL 500 MG | Marketed |
| 02569477 | MYCOPHENOLATE MOFETIL | SIVEM PHARMACEUTICALS ULC | Tablet | MYCOPHENOLATE MOFETIL 500 MG | Approved |
| 02569469 | MYCOPHENOLATE MOFETIL | SIVEM PHARMACEUTICALS ULC | Capsule | MYCOPHENOLATE MOFETIL 250 MG | Approved |
| 02457369 | MYCOPHENOLATE MOFETIL | SANIS HEALTH INC | Capsule | MYCOPHENOLATE MOFETIL 250 MG | Marketed |
| 02313855 | SANDOZ MYCOPHENOLATE MOFETIL | SANDOZ CANADA INCORPORATED | Tablet | MYCOPHENOLATE MOFETIL 500 MG | Marketed |
| 02320630 | SANDOZ MYCOPHENOLATE MOFETIL | SANDOZ CANADA INCORPORATED | Capsule | MYCOPHENOLATE MOFETIL 250 MG | Marketed |
| 02389754 | TARO-MYCOPHENOLATE | SUN PHARMA CANADA INC | Tablet | MYCOPHENOLATE MOFETIL 500 MG | Approved |
| 02364883 | TEVA-MYCOPHENOLATE | TEVA CANADA LIMITED | Capsule | MYCOPHENOLATE MOFETIL 250 MG | Marketed |
| 02348675 | TEVA-MYCOPHENOLATE | TEVA CANADA LIMITED | Tablet | MYCOPHENOLATE MOFETIL 500 MG | Marketed |
| 02401053 | ACCEL-MYCOPHENOLATE MOFETIL CAPSULES | ACCEL PHARMA INC | Capsule | MYCOPHENOLATE MOFETIL 250 MG | Cancelled Pre Market |
| 02400723 | ACCEL-MYCOPHENOLATE MOFETIL TABLETS | ACCEL PHARMA INC | Tablet | MYCOPHENOLATE MOFETIL 500 MG | Cancelled Pre Market |
| 02352567 | APO-MYCOPHENOLATE | APOTEX INC | Tablet | MYCOPHENOLATE MOFETIL 500 MG | Dormant |
| 02352559 | APO-MYCOPHENOLATE | APOTEX INC | Capsule | MYCOPHENOLATE MOFETIL 250 MG | Dormant |
| 02379996 | CO MYCOPHENOLATE | COBALT PHARMACEUTICALS COMPANY | Tablet | MYCOPHENOLATE MOFETIL 500 MG | Cancelled Post Market |
| 02370549 | MYLAN-MYCOPHENOLATE | MYLAN PHARMACEUTICALS ULC | Tablet | MYCOPHENOLATE MOFETIL 500 MG | Cancelled Post Market |
| 02371154 | MYLAN-MYCOPHENOLATE | MYLAN PHARMACEUTICALS ULC | Capsule | MYCOPHENOLATE MOFETIL 250 MG | Cancelled Post Market |
| 02432625 | VAN-MYCOPHENOLATE | VANC PHARMACEUTICALS INC | Tablet | MYCOPHENOLATE MOFETIL 500 MG | Cancelled Post Market |
| 02433680 | VAN-MYCOPHENOLATE | VANC PHARMACEUTICALS INC | Capsule | MYCOPHENOLATE MOFETIL 250 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 25486 | 2021-03-19 | Abbreviated New Drug Submission (ANDS) | REVERT BACK TO IN-HOUSE PRODUCT. NEW DIN REQUEST. UPDATE PRODUCT NAME |
International API supply for MYCOPHENOLATE MOFETIL
11 valid EDQM Certificates of Suitability from 11 holders. 21 active FDA Drug Master Files.
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