APO-DABIGATRAN DIN 02468905
Status: Marketed
Holder: APOTEX INC
Available to quote
Health Canada record
| Active ingredient(s) | DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 110 MG |
|---|---|
| Dosage form | Capsule |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | B01AE07 DABIGATRAN ETEXILATE |
| Original market date | 04-Feb-2019 |
| Current status date | 05-Oct-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 DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02468891 | APO-DABIGATRAN | APOTEX INC | Capsule | DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 75 MG | Marketed |
| 02468913 | APO-DABIGATRAN | APOTEX INC | Capsule | DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 150 MG | Marketed |
| 02358808 | PRADAXA | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Capsule | DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 150 MG | Marketed |
| 02312441 | PRADAXA | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Capsule | DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 110 MG | Marketed |
| 02312433 | PRADAXA | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Capsule | DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 75 MG | Cancelled Post Market |
| 02463458 | TEVA-DABIGATRAN | TEVA CANADA LIMITED | Capsule | DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 75 MG | Cancelled Pre Market |
| 02463466 | TEVA-DABIGATRAN | TEVA CANADA LIMITED | Capsule | DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 150 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 20501 | 2018-02-19 | Abbreviated New Drug Submission (ANDS) |