FDA Approval Activities for this Drug…

Foradil Aerolizer (formoterol fumarate inhalation powder),Rx Novartis NDA 20-831 2/16/01 4/24/03 5/15/01 Foradil Indications: for long-term, twice daily (morning and evening) administration in the maintenance treatment of asthma and in the prevention of bronchospasm in adults and children 5 years of age and older with reversibel obstructive airways disease, including patients with symptoms of nocturnal asthma, who requir4e regular treatment with inhaled, short-acting, beta2-agonists. Foradil (Formoterol Fumarate) Aerolizer Inhalation Powder, Novartis NDA 20-831/S005 6/27/03 7/6/03 7/8/03 Foradil (Formoterol Fumarate Inhalation Powder) Aerolizer Novartis NDA 21-279 & 20-831/S002

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