EPIRUBICIN HYDROCHLORIDE INJECTION DIN 02413221
Health Canada record
| Active ingredient(s) | EPIRUBICIN HYDROCHLORIDE 2 MG |
|---|---|
| Dosage form | Solution |
| Route | Intravenous |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L01DB03 EPIRUBICIN |
| Original market date | |
| Current status date | 19-May-2020 |
| Source | Health Canada DPD |
Establishment licence of the holder
Strides Pharma Canada Inc. — licence 3-002485, currently licensed, last inspection rating C (2026-03-10).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing EPIRUBICIN HYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02409372 | EPIRUBICIN HYDROCHLORIDE INJECTION | OMEGA LABORATORIES LIMITED | Solution | EPIRUBICIN HYDROCHLORIDE 2 MG | Approved |
| 02324091 | EPIRUBICIN HYDROCHLORIDE INJECTION | TEVA CANADA LIMITED | Solution | EPIRUBICIN HYDROCHLORIDE 2 MG | Marketed |
| 02322242 | EPIRUBICIN HYDROCHLORIDE INJECTION | UMAN PHARMA INC | Solution | EPIRUBICIN HYDROCHLORIDE 2 MG | Approved |
| 02301067 | EPIRUBICIN HYDROCHLORIDE FOR INJECTION | HOSPIRA HEALTHCARE ULC | Powder For Solution | EPIRUBICIN HYDROCHLORIDE 50 MG | Cancelled Post Market |
| 02387379 | EPIRUBICIN HYDROCHLORIDE INJECTION | SANDOZ CANADA INCORPORATED | Solution | EPIRUBICIN HYDROCHLORIDE 2 MG | Cancelled Pre Market |
| 02264927 | EPIRUBICIN HYDROCHLORIDE INJECTION | PFIZER CANADA ULC | Solution | EPIRUBICIN HYDROCHLORIDE 2 MG | Cancelled Post Market |
| 02303892 | EPIRUBICIN HYDROCHLORIDE INJECTION | ACCORD HEALTHCARE INC | Solution | EPIRUBICIN HYDROCHLORIDE 2 MG | Cancelled Post Market |
| 02312093 | EPIRUBICIN HYDROCHLORIDE INJECTION | FRESENIUS KABI CANADA LTD | Solution | EPIRUBICIN HYDROCHLORIDE 2.0 MG | Dormant |
| 02323001 | EPIRUBICIN HYDROCHLORIDE INJECTION | PHARMACEUTICAL PARTNERS OF CANADA INC | Solution | EPIRUBICIN HYDROCHLORIDE 2 MG | Cancelled Pre Market |
| 02065703 | PHARMORUBICIN PFS | PHARMASCIENCE INC | Solution | EPIRUBICIN HYDROCHLORIDE 2 MG | Cancelled Post Market |
| 02065746 | PHARMORUBICIN RDF | PFIZER CANADA ULC | Powder For Solution | EPIRUBICIN HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02069512 | PHARMORUBICIN RDF | PFIZER CANADA ULC | Powder For Solution | EPIRUBICIN HYDROCHLORIDE 50 MG | Cancelled Post Market |
| 00640069 | PHARMORUBICIN RDF INJ 50MG/VIAL | ADRIA LABORATORIES OF CANADA LTD. | Powder For Solution | EPIRUBICIN HYDROCHLORIDE 50 MG | Cancelled Post Market |
| 02410400 | PMS-EPIRUBICIN | PHARMASCIENCE INC | Solution | EPIRUBICIN HYDROCHLORIDE 2 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 23641 | 2020-05-19 | Abbreviated New Drug Submission (ANDS) | Administrative: Change in Product Ownership |
| 15749 | 2014-06-24 | Abbreviated New Drug Submission (ANDS) | MERGER - BUYOUT |
| 14758 | 2013-09-24 | Abbreviated New Drug Submission (ANDS) |
International API supply for EPIRUBICIN HYDROCHLORIDE
7 valid EDQM Certificates of Suitability from 7 holders. 7 active FDA Drug Master Files.
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