Treats asthma. ANDA 204604, held by Amneal Pharms. Montelukast Sodium.
As of Nov 15, 2026, ANDA 204604 (Montelukast Sodium), held by Amneal Pharms, was first approved by FDA on Sep 4, 2015, with 6 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 |
|---|---|---|---|
| Sep 4, 2015 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Montelukast SodiumEQ 10MG BASE · tablet;oral | Montelukast Sodium | Rx |
| Sep 30, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 30, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 30, 2025 | Supplement 6Labeling · Standard review | Approved | None posted |
| Dec 6, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 6, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Dec 6, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 4, 2015 | 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
