Approval · Notice of Compliance 34914 · 2025
SILENOR: Notice of Compliance 34914
Issued February 27, 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
- 34914
- Date
- February 27, 2025
- Company
- Endo Operations Ltd.Ballsbridge, Dublin, Ireland
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Labelling Only
- Reason
- Update to the Product Monograph with new safety information. Update to package labels. Change in product ownership
Products in this notice
Medicinal ingredients
- DOXEPIN HCL 3 MG per TAB
- DOXEPIN HCL 6 MG per TAB