Approval · Notice of Compliance 20755 · 2018
XTANDI: Notice of Compliance 20755
Issued April 18, 2018
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
- 20755
- Date
- April 18, 2018
- Company
- Astellas Pharma Canada IncMarkham, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a manufacturee site for the drug substance and alternate site for microbial testing
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| XTANDI | Not yet assigned | — |
Medicinal ingredients
- ENZALUTAMIDE 40 MG per CAP