Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com