Approval · Notice of Compliance 35602 · 2025
CORZYNA: Notice of Compliance 35602
Issued June 30, 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
- 35602
- Date
- June 30, 2025
- Company
- Kye Pharmaceuticals Inc.Mississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Product Monograph reformatted to the Master Template. Addition of new strength: 375 and 750 mg. Addition of a manufacturing site and/or manufacturer involving production of the starting material. Addition of a drug product manufacturing site and/or manufacturer involving production. New package insert. New package labels
Products in this notice
Medicinal ingredients
- RANOLAZINE 375 MG per TAB
- RANOLAZINE 500 MG per TAB
- RANOLAZINE 750 MG per TAB
- RANOLAZINE 1,000 MG per TAB