BUSULFAN INJECTION DIN 02473127
Health Canada record
| Active ingredient(s) | BUSULFAN 60 MG |
|---|---|
| Dosage form | Solution |
| Route | Intravenous |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L01AB01 BUSULFAN |
| Original market date | |
| Current status date | 16-Feb-2018 |
| 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 BUSULFAN
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02475006 | BUSULFAN FOR INJECTION | MARCAN PHARMACEUTICALS INC | Solution | BUSULFAN 60 MG | Approved |
| 02463733 | BUSULFAN FOR INJECTION | STERIMAX INC | Solution | BUSULFAN 60 MG | Marketed |
| 02521296 | BUSULFAN FOR INJECTION | AURO PHARMA INC | Solution | BUSULFAN 60 MG | Approved |
| 02536935 | BUSULFAN FOR INJECTION | EUGIA PHARMA INC. | Solution | BUSULFAN 60 MG | Approved |
| 00004618 | MYLERAN | ASPEN PHARMACARE CANADA INC. | Tablet | BUSULFAN 2 MG | Marketed |
| 02477343 | PMS-BUSULFAN | PHARMASCIENCE INC | Solution | BUSULFAN 6 MG | Marketed |
| 02240602 | BUSULFEX | OTSUKA PHARMACEUTICAL CO LTD | Solution | BUSULFAN 60 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 20492 | 2018-02-16 | Abbreviated New Drug Submission (ANDS) |
International API supply for BUSULFAN
7 valid EDQM Certificates of Suitability from 7 holders. 6 active FDA Drug Master Files.
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