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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 | Albuterol sulfate HFA Inhalation Aerosol, IVAX Research, Approval | Ventolin HFA (albuterol sulfate) Inhalation Aerosol, GlaxoSmithKline, Control Supplement | Albuterol Sulfate HFA Inhalation Aerosol, IVAX Research, Control Supplement | DuoNeb (ipratropium bromide and albuterol sulfate) Inhalation Solution, Dey, Control Supplement | ProAir HFA (albuterol sulfate) Inhalation Aerosol, IVAX Research, Labeling Revision | ProAir HFA (Albuterol Sulfate) Inhalation Aerosol, Ivax Research, New or Modified Indication | Albuterol Sulfate Inhalation Solution, RxElite, Approval | Combivent (ipratropium bromide/albuterol sulfate) Inhalation Aerosol, Boehringer Pharma, Labeling Revision | AccuNeb (albuterol sulfate) Inhalation Aerosol, Dey, L.P., Labeling Revision | DuoNeb (ipratropium bromide and albuterol sulfate) Inhalation Aerosol, Dey, L.P., Labeling Revision | Proventil (albuterol, USP) Inhalation Aerosol, Schering Corp., Labeling Revision | Albuterol Sulfate and Ipratropium Bromide Inhalation Solution, Sandoz Inc., Approval | Albuterol Sulfate Syrup, Vintage Pharma, Approval | Albuterol Sulfate Extended-release Tablets, Mylan Pharma, Approval | Albuterol Sulfate Inhalation Solution, Apotex Corp., Approval | Albuterol sulfate ipratropium bromide Inhalation Solution, Watson Labs, Tentative Approval | Albuterol Sulfate & Ipratropium Bromide Injection, Breath Ltd., Tentative Approval | Albuterol Sulfate and Ipratropium Bromide Inhalation Solution, Apotex, Tentative Approval | Albuterol Sulfate Syrup, VistaPharm, Approval | Albuterol Sulfate and Ipratropium Bromide Inhalation Solution, Nephron Pharma, Tentative Approval | Albuterol Sulfate Inhalation Solution, Watson Labs, Approval | Ventolin HFA (albuterol sulfate) Inhalation Aerosol, GlaxoSmithKline, Efficacy Supplement with Clinical Data to Support | Proair HFA (albuterol sulfate) Inhalation Aerosol, Teva Global Regulatory Research, LLC, Patient Population Altered | Combivent (ipratropium bromide and albuterol sulfate) Inhalation Aerosol, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision | Albuterol Sulfate Inhalation Solution, Lannett, Approval | Combivent (albuterol sulfate and ipratropium bromide) Inhalation Aerosol, Boehringer Ingelheim Pharmaceuticals, Inc, Labeling Revision | Combivent (ipratropium bromide and albuterol sulfate), Inhalation Aerosol, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
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