FDA Approval Activities for this Drug…
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, Albuterol Sulfate Inhalation Solution, Breath Limited Proventil HFA (albuterol sulfate) Inhalation Aerosol, 3M Pharmaceuticals
Albuterol Sulfate Inhalation Solution, Nephron Pharmaceuticals, Approval
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