Approval · Notice of Compliance 3264 · 1997
FOSAMAX: Notice of Compliance 3264
Issued September 10, 1997
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
- 3264
- Date
- September 10, 1997
- Company
- Merck Frosst Canada Inc.Kirkland, QC, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication for the prevention of osteoporosis in postmenopausal women and new 5mg tablet strength
- Therapeutic class
- Bone metabolism regulator
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FOSAMAX | 02233055 | Cancelled Post Market |
Medicinal ingredients
- ALENDRONATE SODIUM 5 MG per TAB