XULTOPHY DIN 02474875
Status: Cancelled Post Market
Holder: NOVO NORDISK CANADA INC
Molecule: INSULIN DEGLUDEC
Available to quote
Health Canada record
| Active ingredient(s) | INSULIN DEGLUDEC 100 UNIT; LIRAGLUTIDE 3.6 MG |
|---|---|
| Dosage form | Solution |
| Route | Subcutaneous |
| Schedule | SCHEDULE D; PRESCRIPTION |
| Class | Human |
| ATC | A10AE56 INSULIN DEGLUDEC AND LIRAGLUTIDE |
| Original market date | 06-Jun-2018 |
| Current status date | 31-Dec-2025 |
| Source | Health Canada DPD |
Establishment licence of the holder
Novo Nordisk Canada Inc — licence 100175, currently licensed, last inspection rating C (2023-02-13).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing INSULIN DEGLUDEC
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02467860 | TRESIBA | NOVO NORDISK CANADA INC | Solution | INSULIN DEGLUDEC 100 UNIT | Marketed |
| 02467879 | TRESIBA | NOVO NORDISK CANADA INC | Solution | INSULIN DEGLUDEC 100 UNIT | Marketed |
| 02467887 | TRESIBA | NOVO NORDISK CANADA INC | Solution | INSULIN DEGLUDEC 200 UNIT | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 20731 | 2018-04-11 | New Drug Submission (NDS) |
International API supply for INSULIN DEGLUDEC
4 active FDA Drug Master Files.
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