Approval · Notice of Compliance 35755 · 2025
SUMATRIPTAN INJECTION, USP: Notice of Compliance 35755
Issued July 28, 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
- 35755
- Date
- July 28, 2025
- Company
- Sterimax Inc.Oakville, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Replacement of a primary container closure system. Update to Product Monograph (to align with CRP approved PM). New package insert. Update to package labels. New package labels
- Canadian reference product
- IMITREX (Glaxosmithkline Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SUMATRIPTAN INJECTION, USP | Not yet assigned | — |
Medicinal ingredients
- SUMATRIPTAN SUCCINATE 6 MG per 0.5ML