MINT-APREMILAST DIN 02525747
Health Canada record
| Active ingredient(s) | APREMILAST 30 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L04AA32 APREMILAST |
| Original market date | 06-Jan-2023 |
| Current status date | 20-Aug-2025 |
| Source | Health Canada DPD |
Establishment licence of the holder
Mint Pharmaceuticals Inc — licence 101613, currently licensed, last inspection rating C (2023-01-16).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing APREMILAST
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02571021 | ACCEL-APREMILAST | ACCEL PHARMA INC | Tablet | APREMILAST 30 MG | Approved |
| 02538180 | APO-APREMILAST | APOTEX INC | Tablet | APREMILAST 30 MG | Marketed |
| 02538172 | APO-APREMILAST | APOTEX INC | Tablet | APREMILAST 10 MG; APREMILAST 20 MG; APREMILAST 30 MG | Approved |
| 02541661 | APO-APREMILAST TABLETS | APOTEX INC | Tablet | APREMILAST 10 MG; APREMILAST 20 MG; APREMILAST 30 MG | Approved |
| 02541688 | APO-APREMILAST TABLETS | APOTEX INC | Tablet | APREMILAST 30 MG | Approved |
| 02524104 | AURO-APREMILAST | AURO PHARMA INC | Tablet | APREMILAST 30 MG | Marketed |
| 02524112 | AURO-APREMILAST | AURO PHARMA INC | Tablet | APREMILAST 10 MG; APREMILAST 20 MG; APREMILAST 30 MG | Approved |
| 02524120 | AURO-APREMILAST | AURO PHARMA INC | Tablet | APREMILAST 10 MG; APREMILAST 20 MG; APREMILAST 30 MG | Marketed |
| 02518929 | GLN-APREMILAST | GLENMARK PHARMACEUTICALS CANADA INC. | Tablet | APREMILAST 10 MG; APREMILAST 20 MG; APREMILAST 30 MG | Approved |
| 02518910 | GLN-APREMILAST | GLENMARK PHARMACEUTICALS CANADA INC. | Tablet | APREMILAST 30 MG | Marketed |
| 02528959 | JAMP APREMILAST | JAMP PHARMA CORPORATION | Tablet | APREMILAST 30 MG | Marketed |
| 02528967 | JAMP APREMILAST | JAMP PHARMA CORPORATION | Tablet | APREMILAST 10 MG; APREMILAST 20 MG; APREMILAST 30 MG | Marketed |
| 02528347 | MAR-APREMILAST | MARCAN PHARMACEUTICALS INC | Tablet | APREMILAST 10 MG; APREMILAST 20 MG; APREMILAST 30 MG | Approved |
| 02528355 | MAR-APREMILAST | MARCAN PHARMACEUTICALS INC | Tablet | APREMILAST 30 MG | Approved |
| 02434318 | OTEZLA | AMGEN CANADA INC | Tablet | APREMILAST 10 MG; APREMILAST 20 MG; APREMILAST 30 MG | Marketed |
| 02434334 | OTEZLA | AMGEN CANADA INC | Tablet | APREMILAST 30 MG | Marketed |
| 02521733 | PMS-APREMILAST | PHARMASCIENCE INC | Tablet | APREMILAST 30 MG | Marketed |
| 02529092 | SANDOZ APREMILAST | SANDOZ CANADA INCORPORATED | Tablet | APREMILAST 10 MG; APREMILAST 20 MG; APREMILAST 30 MG | Marketed |
| 02529084 | SANDOZ APREMILAST | SANDOZ CANADA INCORPORATED | Tablet | APREMILAST 30 MG | Marketed |
| 02521725 | PMS-APREMILAST | PHARMASCIENCE INC | Tablet | APREMILAST 10 MG; APREMILAST 20 MG; APREMILAST 30 MG | Cancelled Pre Market |
| 02517493 | TEVA-APREMILAST | TEVA CANADA LIMITED | Tablet | APREMILAST 30 MG | Cancelled Pre Market |
| 02517485 | TEVA-APREMILAST | TEVA CANADA LIMITED | Tablet | APREMILAST 10 MG; APREMILAST 20 MG; APREMILAST 30 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 29446 | 2022-11-14 | Abbreviated New Drug Submission (ANDS) |
International API supply for APREMILAST
35 active FDA Drug Master Files.
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