Treats asthma. ANDA 209012, held by Rising. Montelukast Sodium.
As of Nov 15, 2026, ANDA 209012 (Montelukast Sodium), held by Rising, was first approved by FDA on Apr 24, 2017, with 2 approved supplements and 0 published complete response letters.
Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 15 years of age and older. Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older. Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies. Limitations of Use: Not indicated to treat an acute asthma attack. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 24, 2017 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Montelukast SodiumEQ 10MG BASE · tablet;oral | Montelukast Sodium | Rx |
| May 17, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 17, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Apr 24, 2017 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
