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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 | Proventil HFA (albuterol sulfate) Inhalation Aerosol, 3M Pharmaceuticals, Supplement | Albuterol Sulfate Inhalation Solution, Apotex Inc., Approval | Albuterol Sulfate Syrup, Amneal Pharmaceuticals, Approval | ProAir HFA (albuterol sulfate) Inhalation Aerosol, Teva Branded Pharmaceuticals, Labeling Revision | ProAir (albuterol sulfate) Inhalation Aerosol, Teva Branded Pharmaceutical Products R&D, Inc., Labeling Revision | AccuNeb (albuterol sulfate) Inhalation Solution, Dey Pharma, L.P., Labeling Revision | DuoNeb (albuterol sulfate and ipratropium bromide) Inhalation Solution, Dey Pharma, L.P., Labeling Revision | Combivent (ipratropium bromide and albuterol sulfate) Inhalation Aerosol, Boehringer Ingelheim Pharmaceutical, Inc., Labeling Revision | Combivent Respimat (ipratropium bromide and albuterol) Nasal Spray, Boehringer Ingelheim Pharmaceutical, Inc., Approval | Duoneb, albuterol sulfate; ipratropium bromide, Solution; Inhalation, Dey, Labeling Revision | Proventil-Hfa, albuterol sulfate, Aerosol, Metered; Inhalation, 3m, Labeling Revision | Combivent, albuterol sulfate; ipratropium bromide, Aerosol, Metered; Inhalation, Boehringer Ingelheim, Labeling Revision | Combivent Respimat, albuterol sulfate; ipratropium bromide, Spray, Metered; Inhalation, Boehringer Ingelheim, Labeling Revision | Ventolin Hfa, albuterol sulfate, Aerosol, Metered; Inhalation, Glaxosmithkline, Labeling Revision | Combivent, albuterol sulfate; ipratropium bromide, Aerosol, Metered; Inhalation, Boehringer Ingelheim, Approval | Albuterol Sulfate and Ipratropium Bromide, albuterol sulfate; ipratropium bromide, Solution; Inhalation, Ritedose Corp, Approval | Proair Hfa, albuterol sulfate, Aerosol, Metered; Inhalation, Teva Global, Manufacturing Change or Addition | Proair Hfa, albuterol sulfate, Aerosol, Metered; Inhalation, Teva Global, Manufacturing Change or Addition | Combivent Respimat, albuterol sulfate; ipratropium bromide, Spray, Metered; Inhalation, Boehringer Ingelheim, Manufacturing Change or Addition | Proventil-Hfa, albuterol sulfate, Aerosol, Metered; Inhalation, 3m, Manufacturing Change or Addition | Proair Hfa, albuterol sulfate, Aerosol, Metered; Inhalation, Teva Global, Manufacturing Change or Addition
  
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