Treats bronchoconstriction. ANDA 218308, held by Deva Holding As. Formoterol Fumarate.
As of Nov 15, 2026, ANDA 218308 (Formoterol Fumarate), held by Deva Holding As, was first approved by FDA on Feb 11, 2025, with 0 approved supplements 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 |
|---|---|---|---|
| Feb 11, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Formoterol Fumarate0.02MG/2ML · solution;inhalation | Formoterol Fumarate | Rx |
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
