Approval · Notice of Compliance 9783 · 2008
PRO-SOTALOL: Notice of Compliance 9783
Issued September 12, 2008
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
- 9783
- Date
- September 12, 2008
- Company
- Pro Doc LimiteeLaval, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- New manufacturer and product name
- Therapeutic class
- Antiarrhythmic
- Canadian reference product
- SOTACOR (Bristol-Myers Squibb Canada)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PRO-SOTALOL | 02316528 | Cancelled Post Market |
| PRO-SOTALOL | 02316536 | Cancelled Post Market |
Medicinal ingredients
- SOTALOL HYDROCHLORIDE 80 MG per TAB
- SOTALOL HYDROCHLORIDE 160 MG per TAB