IRINOTECAN HYDROCHLORIDE INJECTION USP DIN 02258218
Health Canada record
| Active ingredient(s) | IRINOTECAN HYDROCHLORIDE 20 MG |
|---|---|
| Dosage form | Solution |
| Route | Intravenous |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L01CE02 IRINOTECAN |
| Original market date | 01-Feb-2006 |
| Current status date | 13-Mar-2018 |
| Source | Health Canada DPD |
Establishment licence of the holder
Pfizer Canada ULC — licence 100255, currently licensed, last inspection rating C (2023-08-07).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing IRINOTECAN HYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02312409 | IRINOTECAN FOR INJECTION | TEVA CANADA LIMITED | Solution | IRINOTECAN HYDROCHLORIDE 20 MG | Marketed |
| 02528800 | IRINOTECAN HYDROCHLORIDE INJECTION | EUGIA PHARMA INC. | Solution | IRINOTECAN HYDROCHLORIDE 100 MG | Marketed |
| 02528770 | IRINOTECAN HYDROCHLORIDE INJECTION | EUGIA PHARMA INC. | Solution | IRINOTECAN HYDROCHLORIDE 40 MG | Approved |
| 02528789 | IRINOTECAN HYDROCHLORIDE INJECTION | EUGIA PHARMA INC. | Solution | IRINOTECAN HYDROCHLORIDE 500 MG | Marketed |
| 02528797 | IRINOTECAN HYDROCHLORIDE INJECTION | EUGIA PHARMA INC. | Solution | IRINOTECAN HYDROCHLORIDE 300 MG | Approved |
| 02501260 | IRINOTECAN HYDROCHLORIDE INJECTION | AURO PHARMA INC | Solution | IRINOTECAN HYDROCHLORIDE 40 MG | Approved |
| 02501279 | IRINOTECAN HYDROCHLORIDE INJECTION | AURO PHARMA INC | Solution | IRINOTECAN HYDROCHLORIDE 100 MG | Marketed |
| 02501287 | IRINOTECAN HYDROCHLORIDE INJECTION | AURO PHARMA INC | Solution | IRINOTECAN HYDROCHLORIDE 300 MG | Approved |
| 02501295 | IRINOTECAN HYDROCHLORIDE INJECTION | AURO PHARMA INC | Solution | IRINOTECAN HYDROCHLORIDE 500 MG | Marketed |
| 02231622 | CAMPTOSAR | PFIZER CANADA ULC | Solution | IRINOTECAN HYDROCHLORIDE 20 MG | Cancelled Post Market |
| 02410419 | IRINOTECAN | PFIZER CANADA ULC | Solution | IRINOTECAN HYDROCHLORIDE 20 MG | Cancelled Post Market |
| 02305143 | IRINOTECAN HYDROCHLORIDE TRIHYDRATE INJECTION | SANDOZ CANADA INCORPORATED | Solution | IRINOTECAN HYDROCHLORIDE 20 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 20621 | 2018-03-13 | Abbreviated New Drug Submission (ANDS) | Manufacturer and product name change Revisions to product monograph, labels and package insert |
| 8843 | 2007-06-14 | Abbreviated New Drug Submission (ANDS) | MANUFACTURER NAME CHANGE |
| 7652 | 2005-12-14 | Abbreviated New Drug Submission (ANDS) |
International API supply for IRINOTECAN HYDROCHLORIDE
15 active FDA Drug Master Files.
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