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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 | Foradil Aerolizer (formoterol fumarate) Inhalation Powder, Novartis Pharma, Labeling Revision | SYMBICORT (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol, AstraZeneca Pharma, Approval | Foradil Certihaler, Novartis Pharma, Approval | Symbicort (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol, Astra Zeneca, Control Supp. | SYMBICORT (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol, AstraZeneca Pharma, Labeling Revision | SYMBICORT (budesonide and formoterol fumarate dihydrate) Inhalation Spray, AstraZeneca Pharmaceuticals, Labeling Revision | Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Spray, AstraZeneca LP, New or Modified Indication | Dulera (mometasone furoate and formoterol fumarate) Inhalation Aerosol, Schering Corp., Approval | Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Spray, AstraZeneca LP, Labeling Revision | Perforomist (formoterol fumarate) Inhalation Solution, Dey Pharma, LP, Supplement | Foradil (formoterol fumarate) Inhalation Powder, Novartis Pharmaceutical Corp., Labeling Revision | Foradil (formoterol fumarate) Inhalation Powder, Novartis Pharmaceuticals Corp., Labeling Revision | Foradil (formoterol fumarate) Inhalation Powder, Novartis Pharmaceuticals Corp., Labeling Revision | Dulera (mometasone furoate and formoterol fumarate) Inhalation Aerosol, Schering-Plough Corp., Labeling Revision | Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Spray, AstraZeneca, LP, Labeling Revision
  
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