Albuterol Extended-release Tablets, 4 & 8 mg, Sidmak , ANDA 76-130 9/26/02 Albuterol Sulfate Inhalation Solution, 0.5% (base) Nephron ANDA 74-664 6/26/01 4/14/03 Albuterol Sulfate Inhalation Solution, 0.5% (base) Hi-Tech Pharmacal ANDA 74-543 1/15/98 4/27/98 Albuterol Sulfate Inhalation Solution, 0.5% (Base) Bausch & Lomb ANDA 75-050 6/18/98 6/18/98 Albuterol Sulfate Inhalation Solution, 0.083% (base) Hi-Tech Pharmacal ANDA 75-063 2/9/99 2/10/99 4/27/99 Albuterol Sulfate Inhalation Solution, 0.083% (base), Roxane , ANDA 75-129 2/13/01 3/6/01 Albuterol Sulfate Inhalation Solution, 0.083% (base) Zenith Goldline ANDA 75-343 11/9/99 12/30/99 7/11/01 Albuterol Sulfate Inhalation Solution, 0.083% (base), Bausch & Lomb ANDA 75-358 3/29/00 3/31/00 12/18/01 12/18/01 Albuterol Sulfate Inhalation Solution, 0.083% (base) Morton Grove ANDA 75-394 11/22/99 12/29/99 Albuterol Sulfate Syrup, 2 mg(base)/5 mL, UDL , ANDA 75-262 DuoNeb (3.0 mg albuterol sulfate and 0.5 mg ipratropium bromide per 3 mL) Inhalation Solution,Rx Dey NDA 20-950 3/21/01 3/5/02 3/5/02 3/5/02 DuoNeb Indications: treatment of bronchospasm associated with COPD in patients who require more than one bronchodilator. Proventil (albuterol sulfate) Inhalation Aerosol Schering NDA 17-559/S23, 19-383/S10, & 17-853/S16 11/9/98 5/21/01 Proventil HFA (albuterol sulfate) Inhalation Aerosol 3M NDA 20-503/S-004 9/23/98 9/28/98 9/28/98 5/22/01 Proventil HFA Indication: prevention of exercise-induced bronchospasm in patients 12 years of age and older. Proventil HFA (albuterol sulfate) Inhalation Aerosol, 3M NDA 20-503/S-011 6/2/99 6/7/99 5/23/01 Proventil HFA Indication: This supplemental new drug application provides for lowering the age from 12 years to 4 years and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm. Ventolin (albuterol) inhalation aerosol, GlaxoSmithKline NDA 18-473 6/20/03 7/6/03 Ventolin HFA (albuterol sulfate inhalation aerosol), GlaxoSmithKline NDA 20-983 4/19/01 5/1/01 4/30/01 3/28/02 Ventolin Indications: treatment or prevention of bronchospasm in adults and children 4 years of age and older with reversible obstructive disease and for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. Albuterol Sulfate Inhalation Solution, Nephron , Tentative Approval Albuterol Sulfate Inhalation Solution, Breath Limited