Approval · Notice of Compliance 22037 · 2019
APO-HYDROXYUREA: Notice of Compliance 22037
Issued April 4, 2019
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
- 22037
- Date
- April 4, 2019
- Company
- Apotex Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Labelling Only
- Reason
- Labelling updates
- Canadian reference product
- HYDREA
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| APO-HYDROXYUREA | Not yet assigned | — |
Medicinal ingredients
- HYDROXYUREA 500 MG per CAP