TECFIDERA DIN 02420201
Health Canada record
| Active ingredient(s) | DIMETHYL FUMARATE 240 MG |
|---|---|
| Dosage form | Capsule (Delayed-Release) |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L04AX07 DIMETHYL FUMARATE |
| Original market date | 04-Feb-2014 |
| Current status date | 04-Feb-2014 |
| Source | Health Canada DPD |
Establishment licence of the holder
Biogen Canada Inc — licence 100797, currently licensed, last inspection rating C (2023-03-21).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing DIMETHYL FUMARATE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02505762 | APO-DIMETHYL FUMARATE | APOTEX INC | Capsule (Delayed-Release) | DIMETHYL FUMARATE 120 MG | Marketed |
| 02505770 | APO-DIMETHYL FUMARATE | APOTEX INC | Capsule (Delayed-Release) | DIMETHYL FUMARATE 240 MG | Marketed |
| 02540754 | AURO-DIMETHYL FUMARATE | AURO PHARMA INC | Capsule (Delayed-Release) | DIMETHYL FUMARATE 240 MG | Marketed |
| 02540746 | AURO-DIMETHYL FUMARATE | AURO PHARMA INC | Capsule (Delayed-Release) | DIMETHYL FUMARATE 120 MG | Marketed |
| 02516055 | JAMP DIMETHYL FUMARATE | JAMP PHARMA CORPORATION | Capsule (Delayed-Release) | DIMETHYL FUMARATE 240 MG | Marketed |
| 02516047 | JAMP DIMETHYL FUMARATE | JAMP PHARMA CORPORATION | Capsule (Delayed-Release) | DIMETHYL FUMARATE 120 MG | Marketed |
| 02502704 | MAR-DIMETHYL FUMARATE | MARCAN PHARMACEUTICALS INC | Capsule (Delayed-Release) | DIMETHYL FUMARATE 240 MG | Marketed |
| 02502690 | MAR-DIMETHYL FUMARATE | MARCAN PHARMACEUTICALS INC | Capsule (Delayed-Release) | DIMETHYL FUMARATE 120 MG | Marketed |
| 02497034 | PMS-DIMETHYL FUMARATE | PHARMASCIENCE INC | Capsule (Delayed-Release) | DIMETHYL FUMARATE 240 MG | Marketed |
| 02497026 | PMS-DIMETHYL FUMARATE | PHARMASCIENCE INC | Capsule (Delayed-Release) | DIMETHYL FUMARATE 120 MG | Marketed |
| 02404508 | TECFIDERA | BIOGEN CANADA INC | Capsule (Delayed-Release) | DIMETHYL FUMARATE 120 MG | Marketed |
| 02495368 | ACH-DIMETHYL FUMARATE | ACCORD HEALTHCARE INC | Capsule (Delayed-Release) | DIMETHYL FUMARATE 240 MG | Cancelled Post Market |
| 02495341 | ACH-DIMETHYL FUMARATE | ACCORD HEALTHCARE INC | Capsule (Delayed-Release) | DIMETHYL FUMARATE 120 MG | Cancelled Post Market |
| 02494809 | GLN-DIMETHYL FUMARATE | GLENMARK PHARMACEUTICALS CANADA INC. | Capsule (Delayed-Release) | DIMETHYL FUMARATE 120 MG | Dormant |
| 02494817 | GLN-DIMETHYL FUMARATE | GLENMARK PHARMACEUTICALS CANADA INC. | Capsule (Delayed-Release) | DIMETHYL FUMARATE 240 MG | Dormant |
| 02515563 | SANDOZ DIMETHYL FUMARATE | SANDOZ CANADA INCORPORATED | Capsule (Delayed-Release) | DIMETHYL FUMARATE 120 MG | Cancelled Pre Market |
| 02515571 | SANDOZ DIMETHYL FUMARATE | SANDOZ CANADA INCORPORATED | Capsule (Delayed-Release) | DIMETHYL FUMARATE 240 MG | Cancelled Pre Market |
| 02513803 | SANDOZ DIMETHYL FUMARATE DELAYED-RELEASE CAPSULES | SANDOZ CANADA INCORPORATED | Capsule (Delayed-Release) | DIMETHYL FUMARATE 240 MG | Dormant |
| 02513781 | SANDOZ DIMETHYL FUMARATE DELAYED-RELEASE CAPSULES | SANDOZ CANADA INCORPORATED | Capsule (Delayed-Release) | DIMETHYL FUMARATE 120 MG | Dormant |
| 02493594 | TEVA-DIMETHYL FUMARATE | TEVA CANADA LIMITED | Capsule (Delayed-Release) | DIMETHYL FUMARATE 240 MG | Cancelled Pre Market |
| 02493586 | TEVA-DIMETHYL FUMARATE | TEVA CANADA LIMITED | Capsule (Delayed-Release) | DIMETHYL FUMARATE 120 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 15155 | 2014-01-27 | Supplement to a New Drug Submission (SNDS) | NEW STRENGTH |
International API supply for DIMETHYL FUMARATE
29 active FDA Drug Master Files.
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