Approval · Notice of Compliance 2446 · 2001
SINGULAIR: Notice of Compliance 2446
Issued March 9, 2001
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
- 2446
- Date
- March 9, 2001
- Company
- Merck Frosst Canada & Cie, Merck Frosst Canada & Co.Kirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New dosage strength and new indication: for use in adult and pediatric patients 2 years of age and older for the prophylaxis and chronic treatment of asthma
- Therapeutic class
- Leukotriene receptor antagonist
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SINGULAIR | 02243602 | Marketed |
Medicinal ingredients
- MONTELUKAST SODIUM 4 MG per TAB