Approval · Notice of Compliance 11633 · 2010
ALENDRONATE: Notice of Compliance 11633
Issued July 28, 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
- 11633
- Date
- July 28, 2010
- Company
- Sanis Health Inc.Brampton, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- New manufacturer and product name
- Therapeutic class
- Bone metabolism regulator
- Canadian reference product
- FOSAMAX (Merck Frosst Canada Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ALENDRONATE | 02352958 | — |
| ALENDRONATE | 02352966 | Marketed |
Medicinal ingredients
- ALENDRONATE SODIUM TRIHYDRATE 40 MG per TAB
- ALENDRONATE SODIUM TRIHYDRATE 70 MG per TAB