HYDREA DIN 00465283
Health Canada record
| Active ingredient(s) | HYDROXYUREA 500 MG |
|---|---|
| Dosage form | Capsule |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L01XX05 HYDROXYCARBAMIDE |
| Original market date | 31-Dec-1979 |
| Current status date | 18-Nov-2022 |
| Source | Health Canada DPD |
Establishment licence of the holder
Cheplapharm Arzneimittel GmbH — licence , not currently licensed, last inspection rating C (2024-10-10).
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 |
| 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 |
|---|---|---|---|
| 29415 | 2022-11-08 | New Drug Submission (NDS) | Administrative: Change in Product Ownership |
| 5727 | 2004-10-28 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
International API supply for HYDROXYUREA
4 active FDA Drug Master Files.
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