Approval · Notice of Compliance 10409 · 2009
MYLAN-SUMATRIPTAN: Notice of Compliance 10409
Issued July 21, 2009
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
- 10409
- Date
- July 21, 2009
- Company
- Mylan Pharmaceuticals UlcEtobicoke, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Manufacturer and product name change
- Therapeutic class
- 5-HT1 Receptor agonist / Migraine therapy
- Canadian reference product
- IMITREX (Glaxosmithkline Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| MYLAN-SUMATRIPTAN | 02268906 | Marketed |
| MYLAN-SUMATRIPTAN | 02268914 | Marketed |
| MYLAN-SUMATRIPTAN | 02268922 | Marketed |
Medicinal ingredients
- SUMATRIPTAN SUCCINATE 25 MG per TAB
- SUMATRIPTAN SUCCINATE 50 MG per TAB
- SUMATRIPTAN SUCCINATE 100 MG per TAB