NAT-BENDAMUSTINE DIN 02496887
Health Canada record
| Active ingredient(s) | BENDAMUSTINE HYDROCHLORIDE 25 MG |
|---|---|
| Dosage form | Powder For Solution |
| Route | Intravenous |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L01AA09 BENDAMUSTINE |
| Original market date | 25-Feb-2021 |
| Current status date | 25-Feb-2021 |
| Source | Health Canada DPD |
Establishment licence of the holder
Natco Pharma (Canada) Inc — licence 102058, currently licensed, last inspection rating C (2022-07-26).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing BENDAMUSTINE HYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02509261 | BENDAMUSTINE HYDROCHLORIDE FOR INJECTION | AURO PHARMA INC | Powder For Solution | BENDAMUSTINE HYDROCHLORIDE 100 MG | Marketed |
| 02526972 | BENDAMUSTINE HYDROCHLORIDE FOR INJECTION | HIKMA CANADA LIMITED | Powder For Solution | BENDAMUSTINE HYDROCHLORIDE 25 MG | Approved |
| 02496852 | BENDAMUSTINE HYDROCHLORIDE FOR INJECTION | ACCORD HEALTHCARE INC | Powder For Solution | BENDAMUSTINE HYDROCHLORIDE 25 MG | Marketed |
| 02496860 | BENDAMUSTINE HYDROCHLORIDE FOR INJECTION | ACCORD HEALTHCARE INC | Powder For Solution | BENDAMUSTINE HYDROCHLORIDE 100 MG | Marketed |
| 02541998 | BENDAMUSTINE HYDROCHLORIDE FOR INJECTION | EUGIA PHARMA INC. | Powder For Solution | BENDAMUSTINE HYDROCHLORIDE 25 MG | Marketed |
| 02526980 | BENDAMUSTINE HYDROCHLORIDE FOR INJECTION | HIKMA CANADA LIMITED | Powder For Solution | BENDAMUSTINE HYDROCHLORIDE 100 MG | Approved |
| 02509253 | BENDAMUSTINE HYDROCHLORIDE FOR INJECTION | AURO PHARMA INC | Powder For Solution | BENDAMUSTINE HYDROCHLORIDE 25 MG | Marketed |
| 02542005 | BENDAMUSTINE HYDROCHLORIDE FOR INJECTION | EUGIA PHARMA INC. | Powder For Solution | BENDAMUSTINE HYDROCHLORIDE 100 MG | Marketed |
| 02524309 | BENVYON | PFIZER CANADA ULC | Solution | BENDAMUSTINE HYDROCHLORIDE 25 MG | Marketed |
| 02527073 | ESAMUZE | DR REDDY'S LABORATORIES LTD | Solution | BENDAMUSTINE HYDROCHLORIDE 45 MG | Approved |
| 02496895 | NAT-BENDAMUSTINE | NATCO PHARMA (CANADA) INC | Powder For Solution | BENDAMUSTINE HYDROCHLORIDE 100 MG | Marketed |
| 02392550 | TREANDA | TEVA CANADA LIMITED | Powder For Solution | BENDAMUSTINE HYDROCHLORIDE 25 MG | Marketed |
| 02392569 | TREANDA | TEVA CANADA LIMITED | Powder For Solution | BENDAMUSTINE HYDROCHLORIDE 100 MG | Marketed |
| 02509172 | BENDAMUSTINE HYDROCHLORIDE FOR INJECTION | JAMP PHARMA CORPORATION | Powder For Solution | BENDAMUSTINE HYDROCHLORIDE 100 MG | Dormant |
| 02509164 | BENDAMUSTINE HYDROCHLORIDE FOR INJECTION | JAMP PHARMA CORPORATION | Powder For Solution | BENDAMUSTINE HYDROCHLORIDE 25 MG | Dormant |
| 02498111 | BENDAMUSTINE HYDROCHLORIDE FOR INJECTION | MYLAN PHARMACEUTICALS ULC | Powder For Solution | BENDAMUSTINE HYDROCHLORIDE 100 MG | Cancelled Post Market |
| 02498103 | BENDAMUSTINE HYDROCHLORIDE FOR INJECTION | MYLAN PHARMACEUTICALS ULC | Powder For Solution | BENDAMUSTINE HYDROCHLORIDE 25 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 32804 | 2024-02-29 | Supplement to an Abbreviated New Drug Submission (SANDS) | Control of drug product: change in the specification for the drug product |
| 25279 | 2021-06-30 | Abbreviated New Drug Submission (ANDS) |
International API supply for BENDAMUSTINE HYDROCHLORIDE
14 active FDA Drug Master Files.
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