Approval · Notice of Compliance 10957 · 2010
SIMVASTATIN: Notice of Compliance 10957
Issued January 26, 2010
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
- 10957
- Date
- January 26, 2010
- Company
- Cobalt Pharmaceuticals IncorporatedToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Additional product name
- Therapeutic class
- Lipid metabolism regulator
- Canadian reference product
- ZOCOR (Merck Frosst Canada & Cie, Merck Frosst Canada & Co.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SIMVASTATIN | 02342456 | Cancelled Pre Market |
| SIMVASTATIN | 02342464 | Cancelled Pre Market |
| SIMVASTATIN | 02342472 | Cancelled Pre Market |
| SIMVASTATIN | 02342480 | Cancelled Pre Market |
| SIMVASTATIN | 02342499 | Cancelled Pre Market |
Medicinal ingredients
- SIMVASTATIN 5 MG per TAB
- SIMVASTATIN 10 MG per TAB
- SIMVASTATIN 20 MG per TAB
- SIMVASTATIN 40 MG per TAB
- SIMVASTATIN 80 MG per TAB