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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
  
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