APO-TERIFLUNOMIDE DIN 02500639
Health Canada record
| Active ingredient(s) | TERIFLUNOMIDE 14 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L04AK02 TERIFLUNOMIDE |
| Original market date | 16-May-2022 |
| Current status date | 16-May-2022 |
| 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 TERIFLUNOMIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02500515 | AURO-TERIFLUNOMIDE | AURO PHARMA INC | Tablet | TERIFLUNOMIDE 14 MG | Approved |
| 02504170 | JAMP TERIFLUNOMIDE | JAMP PHARMA CORPORATION | Tablet | TERIFLUNOMIDE 14 MG | Marketed |
| 02523833 | M-TERIFLUNOMIDE | MANTRA PHARMA INC | Tablet | TERIFLUNOMIDE 14 MG | Marketed |
| 02500310 | NAT-TERIFLUNOMIDE | NATCO PHARMA (CANADA) INC | Tablet | TERIFLUNOMIDE 14 MG | Marketed |
| 02500434 | PMS-TERIFLUNOMIDE | PHARMASCIENCE INC | Tablet | TERIFLUNOMIDE 14 MG | Marketed |
| 02505843 | SANDOZ TERIFLUNOMIDE | SANDOZ CANADA INCORPORATED | Tablet | TERIFLUNOMIDE 14 MG | Marketed |
| 02501090 | TEVA-TERIFLUNOMIDE | TEVA CANADA LIMITED | Tablet | TERIFLUNOMIDE 14 MG | Marketed |
| 02502933 | ACH-TERIFLUNOMIDE | ACCORD HEALTHCARE INC | Tablet | TERIFLUNOMIDE 14 MG | Cancelled Post Market |
| 02416328 | AUBAGIO | SANOFI-AVENTIS CANADA INC | Tablet | TERIFLUNOMIDE 14 MG | Cancelled Post Market |
| 02500469 | MAR-TERIFLUNOMIDE | MARCAN PHARMACEUTICALS INC | Tablet | TERIFLUNOMIDE 14 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 28176 | 2022-05-16 | Abbreviated New Drug Submission (ANDS) | |
| 28172 | 2022-05-16 | Supplement to an Abbreviated New Drug Submission (SANDS) | Update to the product monograph as per advisement letter. Update to labels |
International API supply for TERIFLUNOMIDE
15 valid EDQM Certificates of Suitability from 14 holders. 21 active FDA Drug Master Files.
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