ONUREG DIN 02510200
Health Canada record
| Active ingredient(s) | AZACITIDINE 300 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L01BC07 AZACITIDINE |
| Original market date | 10-Mar-2021 |
| Current status date | 31-Jan-2025 |
| Source | Health Canada DPD |
Establishment licence of the holder
Bristol-Myers Squibb Canada — licence 100100, currently licensed, last inspection rating C (2026-03-18).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing AZACITIDINE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02534029 | AZACITIDINE FOR INJECTION | STERIMAX INC | Powder For Suspension | AZACITIDINE 100 MG | Approved |
| 02462826 | AZACITIDINE FOR INJECTION | DR REDDY'S LABORATORIES LTD | Powder For Suspension | AZACITIDINE 100 MG | Marketed |
| 02571102 | AZACITIDINE FOR INJECTION | APOTEX INC | Powder For Suspension | AZACITIDINE 100 MG | Approved |
| 02564998 | AZACITIDINE FOR INJECTION | MSN LABS CANADA INC. | Powder For Suspension | AZACITIDINE 100 MG | Approved |
| 02558815 | AZACITIDINE FOR INJECTION | DR REDDY'S LABORATORIES LTD | Powder For Suspension | AZACITIDINE 150 MG | Approved |
| 02505177 | AZACITIDINE FOR INJECTION | FRESENIUS KABI CANADA LTD | Powder For Suspension | AZACITIDINE 100 MG | Marketed |
| 02507668 | AZACITIDINE FOR INJECTION | HIKMA CANADA LIMITED | Powder For Suspension | AZACITIDINE 100 MG | Marketed |
| 02534037 | AZACITIDINE FOR INJECTION | STERIMAX INC | Powder For Suspension | AZACITIDINE 150 MG | Approved |
| 02529599 | AZACITIDINE FOR INJECTION | SANDOZ CANADA INCORPORATED | Powder For Suspension | AZACITIDINE 100 MG | Marketed |
| 02510197 | ONUREG | BRISTOL-MYERS SQUIBB CANADA | Tablet | AZACITIDINE 200 MG | Marketed |
| 02336707 | VIDAZA | BRISTOL-MYERS SQUIBB CANADA | Powder For Suspension | AZACITIDINE 100 MG | Marketed |
| 02501791 | AZACITIDINE FOR INJECTION | JAMP PHARMA CORPORATION | Powder For Suspension | AZACITIDINE 100 MG | Dormant |
| 02480220 | NAT-AZACITIDINE | NATCO PHARMA (CANADA) INC | Powder For Suspension | AZACITIDINE 100 MG | Cancelled Pre Market |
| 02532085 | PMS-AZACITIDINE FOR INJECTION | PHARMASCIENCE INC | Powder For Suspension | AZACITIDINE 100 MG | Cancelled Pre Market |
| 02463199 | REDDY-AZACITIDINE | DR REDDY'S LABORATORIES LTD | Powder For Suspension | AZACITIDINE 100 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 32806 | 2024-02-29 | New Drug Submission (NDS) | Administrative: Change in Product Ownership |
| 24927 | 2021-01-05 | New Drug Submission (NDS) |
International API supply for AZACITIDINE
19 active FDA Drug Master Files.
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