Approval · Notice of Compliance 34973 · 2025
MYLAN-HYDROXYUREA: Notice of Compliance 34973
Issued March 7, 2025
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 34973
- Date
- March 7, 2025
- Company
- Mylan Pharmaceuticals UlcEtobicoke, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Update to Product Monograph (to align with CRP approved PM). Update to package labels
- Canadian reference product
- HYDREA
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| MYLAN-HYDROXYUREA | Not yet assigned | — |
Medicinal ingredients
- HYDROXYUREA 500 MG per CAP