JARDIANCE DIN 02443937
Status: Marketed
Holder: BOEHRINGER INGELHEIM (CANADA) LTD LTEE
Molecule: EMPAGLIFLOZIN
Available to quote
Health Canada record
| Active ingredient(s) | EMPAGLIFLOZIN 10 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | A10BK03 EMPAGLIFLOZIN |
| Original market date | 11-Aug-2015 |
| Current status date | 11-Aug-2015 |
| Source | Health Canada DPD |
Establishment licence of the holder
Boehringer Ingelheim (Canada) Ltd Ltee — licence 100187, currently licensed, last inspection rating C (2025-03-03).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing EMPAGLIFLOZIN
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02443945 | JARDIANCE | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | EMPAGLIFLOZIN 25 MG | Marketed |
| 02456575 | SYNJARDY | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | EMPAGLIFLOZIN 5 MG; METFORMIN HYDROCHLORIDE 500 MG | Marketed |
| 02456583 | SYNJARDY | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | EMPAGLIFLOZIN 5 MG; METFORMIN HYDROCHLORIDE 850 MG | Marketed |
| 02456591 | SYNJARDY | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | EMPAGLIFLOZIN 5 MG; METFORMIN HYDROCHLORIDE 1000 MG | Marketed |
| 02456613 | SYNJARDY | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | EMPAGLIFLOZIN 12.5 MG; METFORMIN HYDROCHLORIDE 850 MG | Marketed |
| 02456621 | SYNJARDY | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | EMPAGLIFLOZIN 12.5 MG; METFORMIN HYDROCHLORIDE 1000 MG | Marketed |
| 02459752 | GLYXAMBI | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | EMPAGLIFLOZIN 10 MG; LINAGLIPTIN 5 MG | Cancelled Post Market |
| 02459760 | GLYXAMBI | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | EMPAGLIFLOZIN 25 MG; LINAGLIPTIN 5 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 18356 | 2016-08-10 | Supplement to a New Drug Submission (SNDS) | UPDATE TO THE PRODUCT MONOGRAPH IN RESPONSE TO AN ADVISEMENT LETTER ISSUED APRIL 15, 2016 |
| 17124 | 2015-07-23 | New Drug Submission (NDS) |
International API supply for EMPAGLIFLOZIN
59 active FDA Drug Master Files.
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