Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.