FLUOROURACIL INJECTION DIN 02473763
Health Canada record
| Active ingredient(s) | FLUOROURACIL 0.5 G |
|---|---|
| Dosage form | Solution |
| Route | Intravenous |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L01BC02 FLUOROURACIL |
| Original market date | 02-Dec-2021 |
| Current status date | 02-Dec-2021 |
| Source | Health Canada DPD |
Establishment licence of the holder
Biolyse Pharma Corporation — licence 101046, currently licensed, last inspection rating C (2025-11-03).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing FLUOROURACIL
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02428946 | ACTIKERALL | CIPHER PHARMACEUTICALS INC | Solution | FLUOROURACIL 0.5 %; SALICYLIC ACID 10 % | Marketed |
| 00330582 | EFUDEX | BAUSCH HEALTH, CANADA INC. | Cream | FLUOROURACIL 5 % | Marketed |
| 00012882 | FLUOROURACIL INJECTION | SANDOZ CANADA INCORPORATED | Solution | FLUOROURACIL 50 MG | Marketed |
| 02473771 | FLUOROURACIL INJECTION | BIOLYSE PHARMA CORPORATION | Solution | FLUOROURACIL 5 G | Marketed |
| 02476711 | FLUOROURACIL INJECTION | GENERIC MEDICAL PARTNERS INC | Solution | FLUOROURACIL 250 MG | Approved |
| 02476738 | FLUOROURACIL INJECTION | GENERIC MEDICAL PARTNERS INC | Solution | FLUOROURACIL 500 MG | Approved |
| 02476746 | FLUOROURACIL INJECTION | GENERIC MEDICAL PARTNERS INC | Solution | FLUOROURACIL 1000 MG | Approved |
| 02476754 | FLUOROURACIL INJECTION | GENERIC MEDICAL PARTNERS INC | Solution | FLUOROURACIL 5000 MG | Approved |
| 02413450 | FLUOROURACIL INJECTION USP | ACCORD HEALTHCARE INC | Solution | FLUOROURACIL 50 MG | Marketed |
| 02063921 | ADRUCIL | PFIZER CANADA ULC | Solution | FLUOROURACIL 50 MG | Cancelled Post Market |
| 00428493 | ADRUCIL INJ 50MG/ML | ADRIA LABORATORIES OF CANADA LTD. | Liquid | FLUOROURACIL 500 MG | Cancelled Post Market |
| 01982311 | FLUOROPLEX CREAM 1% | ALLERGAN HERBERT SKIN CARE DIVISION OF ALLERGAN INC. | Cream | FLUOROURACIL 1 % | Cancelled Post Market |
| 00891754 | FLUOROURACIL INJ 50MG/ML | DAVID BULL LABORATORIES (PTY) LTD. | Liquid | FLUOROURACIL 50 MG | Cancelled Post Market |
| 02182742 | FLUOROURACIL INJECTION USP | PFIZER CANADA ULC | Solution | FLUOROURACIL 50 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 20597 | 2018-03-12 | Abbreviated New Drug Submission (ANDS) |
International API supply for FLUOROURACIL
2 valid EDQM Certificates of Suitability from 2 holders. 7 active FDA Drug Master Files.
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