Treats bronchoconstriction. ANDA 215883, held by Mankind Pharma. Formoterol Fumarate.
As of Nov 15, 2026, ANDA 215883 (Formoterol Fumarate), held by Mankind Pharma, was first approved by FDA on Mar 22, 2023, with 1 approved supplement and 0 published complete response letters.
Formoterol fumarate inhalation solution is a long-acting beta 2 -adrenergic agonist (beta 2 -agonist) indicated for: Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Important limitations of use: Formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. ( 1.2, 5.2 ) Formoterol fumarate inhalation solution is not indicated to treat asthma. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 22, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Formoterol Fumarate0.02MG/2ML · solution;inhalation | Formoterol Fumarate | Rx |
| Jul 16, 2024 | Supplement 3Manufacturing | Approved | None posted |
| Mar 22, 2023 | 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
