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As of Nov 15, 2026, ANDA 215907 (Formoterol Fumarate), held by Dr Reddys, was first approved by FDA on Jan 30, 2025, with 0 approved supplements and 0 published complete response letters.
First approved: Jan 30, 2025
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
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.
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
