Approval · Notice of Compliance 11240 · 2010
AMIODARONE: Notice of Compliance 11240
Issued April 9, 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
- 11240
- Date
- April 9, 2010
- Company
- Sorres Pharma IncMontreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Manufacturer and product name change
- Therapeutic class
- Antiarrhythmic agent
- Canadian reference product
- CORDARONE (Wyeth-Ayerst Canada Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| AMIODARONE | 02300885 | — |
| AMIODARONE | 02300893 | Cancelled Post Market |
Medicinal ingredients
- AMIODARONE HYDROCHLORIDE 100 MG per TAB
- AMIODARONE HYDROCHLORIDE 200 MG per TAB