MYLAN-HYDROXYUREA DIN 02242920
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-Feb-2001 |
| Current status date | 29-Jan-2010 |
| Source | Health Canada DPD |
Establishment licence of the holder
Mylan Pharmaceuticals ULC — licence 101774, currently licensed, last inspection rating C (2026-02-24).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing HYDROXYUREA
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02247937 | APO-HYDROXYUREA | APOTEX INC | Capsule | HYDROXYUREA 500 MG | Marketed |
| 02552582 | EUGIA-HYDROXYUREA | EUGIA PHARMA INC. | Capsule | HYDROXYUREA 500 MG | Approved |
| 00465283 | HYDREA | CHEPLAPHARM ARZNEIMITTEL GMBH | 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 |
|---|---|---|---|
| 10329 | 2009-07-02 | Abbreviated New Drug Submission (ANDS) | Manufacturer and product name change |
| 1204 | 2000-10-17 | Abbreviated New Drug Submission (ANDS) |
International API supply for HYDROXYUREA
4 active FDA Drug Master Files.
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