Treats asthma. ANDA 210431, held by Torrent. Montelukast Sodium.
As of Nov 15, 2026, ANDA 210431 (Montelukast Sodium), held by Torrent, was first approved by FDA on Jul 31, 2018, with 5 approved supplements and 0 published complete response letters.
Montelukast sodium is a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 12 months of age and older. Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 6 months 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 |
|---|---|---|---|
| Jul 31, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Montelukast SodiumEQ 4MG BASE/PACKET · granule;oral | Montelukast Sodium | Rx |
| Apr 3, 2025 | Supplement 6Labeling · Standard review | Approved | None posted |
| Oct 15, 2021 | Supplement 4Labeling · Standard review | Approved | None posted |
| Nov 24, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 24, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 24, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 31, 2018 | Original application | Approved | None posted |
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
