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… Xopenex (levalbuterol HCl) Inhalation Solution, Sepracor NDA 20-837/S10 7/18/03 7/28/03 Xopenex (levalbuterol HCl) Inhalation Solution, 0.31 mg/3 mL, 0.63 mg/3 mL & 1.25 mg/3 mL Unit-Dose Vials Sepracor Inc Sepracor NDA 20-837/S6 1/30/02 2/8/02 Xopenex Indications: For the treatment or prevention of bronchospasm in children 6 years of age and older with reversible obstructive airway disease. Xopenex (levalbuterol HCl) Inhalation Solution, 0.63 mg/3 mL & 1.25 mg/3 mL Unit-Dose Vials Sepracor NDA 20-837 3/25/99 3/29/99 3/29/99 6/20/01 Xopenex Indications: For the treatment or prevention of bronchospasm in adults and adolescents 12 years of age and older with reversible obstructive airway disease. | Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol, Sepracor, Approval | Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol, Sepracor, Labeling Revision | Xopenex (levalbuterol HCL) Inhalation Solution and Xopenex (levalbuterol HCL) Inhalation Solution Concentrate, Sepracor Inc., Labeling Revision | Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol, Sepracor Inc., Labeling Revision | Levalbuterol Hydrochloride, Inhalation Solution, Breath Ltd, Tentative Approval | Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol, Sepracor Inc., Control Supp. | Levalbuterol Hydrochloride Inhalation Solution, Dey, Tentative Approval | Levalbuterol Hydrochloride Inhalation Solution, Breath Ltd., Approval | Levalbuterol Inhalation Solution, Dey LP, Approval ^ 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