Approval · Notice of Compliance 35329 · 2025
MUSE: Notice of Compliance 35329
Issued May 9, 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
- 35329
- Date
- May 9, 2025
- Company
- Endo Operations Ltd.Ballsbridge, Dublin, Ireland
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Labelling Only
- Reason
- Update to package labels. Update to package insert. Administrative: Change in product ownership. Product Monograph reformatted to the Master Template
Products in this notice
Medicinal ingredients
- ALPROSTADIL 250 MCG per SUP
- ALPROSTADIL 500 MCG per SUP
- ALPROSTADIL 100 MCG per SUP