APO-HYDROXYUREA DIN 02247937
Health Canada record
| Active ingredient(s) | HYDROXYUREA 500 MG |
|---|---|
| Dosage form | Capsule |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L01XX05 HYDROXYCARBAMIDE |
| Original market date | 22-Oct-2003 |
| Current status date | 12-Dec-2017 |
| 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 HYDROXYUREA
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02552582 | EUGIA-HYDROXYUREA | EUGIA PHARMA INC. | Capsule | HYDROXYUREA 500 MG | Approved |
| 00465283 | HYDREA | CHEPLAPHARM ARZNEIMITTEL GMBH | Capsule | HYDROXYUREA 500 MG | Marketed |
| 02242920 | MYLAN-HYDROXYUREA | MYLAN PHARMACEUTICALS ULC | Capsule | HYDROXYUREA 500 MG | Marketed |
| 02530260 | RIVA-HYDROXYUREA | LABORATOIRE RIVA INC. | Capsule | HYDROXYUREA 500 MG | Marketed |
| 02343096 | HYDROXYUREA | SANIS HEALTH INC | Capsule | HYDROXYUREA 500 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 1060 | 2003-09-18 | Abbreviated New Drug Submission (ANDS) |
International API supply for HYDROXYUREA
4 active FDA Drug Master Files.
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