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FDA Approval Activities for this Drug…
Ipratropium Bromide Inhalation Solution, 0.02%, Roxane, ANDA 75-867 7/22/02 Ipratropium Bromide Inhalation Solution, 0.02%, Bausch & Lomb ANDA 75-835 10/15/01 4/15/03 Ipratropium Bromide Inhalation Solution, 0.02%, Aslung Pharmaceutical, L.P. ANDA 75-693 1/26/01 3/5/01 Ipratropium Bromide Inhalation Solution, 0.02%, Nephron ANDA 75-562 9/27/01 4/13/02 Ipratropium Bromide Inhalation Solution, 0.02%, Warrick ANDA 75-507 1/19/01 3/5/01 Ipratropium Bromide Inhalation Solution, 0.02% (packaged in 2.5 mL plastic ampules), Novex Pharma ANDA 75-441 3/28/01 3/30/01 6/11/02 Ipratropium Bromide Inhalation Solution, 0.02% (packaged in 0.5 mg/2.5 mL unit-dose vials) Steripak Limited ANDA 75-313 2/7/00 Ipratropium Bromide Inhalation Solution, 0.02%, Alpharma ANDA 75-111 Ipratropium Bromide Nasal Spray, Roxane ALBUTEROL SULFATE; IPRATROPIUM BROMIDE Aerosol, Metered; Inhalation 0.09MG BASE/INH;0.018MG/INH COMBIVENT BOEHRINGER INGELHEIM 020950 ALBUTEROL SULFATE; IPRATROPIUM BROMIDE Solution; Inhalation 0.083% BASE;0.017% DUONEB Dey 019085 IPRATROPIUM BROMIDE Aerosol, Metered; Inhalation 0.018MG/INH ATROVENT BOEHRINGER INGELHEIM 075111 AN IPRATROPIUM BROMIDE Solution; Inhalation 0.02% IPRATROPIUM BROMIDE ALPHARMA 075693 AN IPRATROPIUM BROMIDE Solution; Inhalation 0.02% IPRATROPIUM BROMIDE ASLUNG 075835 AN IPRATROPIUM BROMIDE Solution; Inhalation 0.02% IPRATROPIUM BROMIDE BAUSCH AND LOMB 020228 AN IPRATROPIUM BROMIDE Solution; Inhalation 0.02% ATROVENT BOEHRINGER INGELHEIM 074755 AN IPRATROPIUM BROMIDE Solution; Inhalation 0.02% IPRATROPIUM BROMIDE Dey 075313 AN IPRATROPIUM BROMIDE Solution; Inhalation 0.02% IPRATROPIUM BROMIDE Ivax 075562 AN IPRATROPIUM BROMIDE Solution; Inhalation 0.02% IPRATROPIUM BROMIDE Nephron 075441 AN IPRATROPIUM BROMIDE Solution; Inhalation 0.02% IPRATROPIUM BROMIDE Novex 075867 AN IPRATROPIUM BROMIDE Solution; Inhalation 0.02% IPATROPIUM BROMIDE Roxane 075507 AN IPRATROPIUM BROMIDE Solution; Inhalation 0.02% IPRATROPIUM BROMIDE WARRICK 076025 IPRATROPIUM BROMIDE Spray, Metered; Nasal 0.021MG/SPRAY IPRATROPIUM BROMIDE BAUSCH AND LOMB 076103 IPRATROPIUM BROMIDE Spray, Metered; Nasal 0.042MG/SPRAY IPRATROPIUM BROMIDE BAUSCH AND LOMB 020393 IPRATROPIUM BROMIDE Spray, Metered; Nasal 0.021MG/SPRAY ATROVENT BOEHRINGER INGELHEIM 020394 IPRATROPIUM BROMIDE Spray, Metered; Nasal 0.042MG/SPRAY ATROVENT BOEHRINGER INGELHEIM 075552 IPRATROPIUM BROMIDE Spray, Metered; Nasal 0.021MG/SPRAY IPRATROPIUM BROMIDE Dey 075553 IPRATROPIUM BROMIDE Spray, Metered; Nasal 0.042MG/SPRAY IPRATROPIUM BROMIDE Dey 076156 IPRATROPIUM BROMIDE Spray, Metered; Nasal 0.021MG/SPRAY IPRATROPIUM BROMIDE Novex 076155 IPRATROPIUM BROMIDE Spray, Metered; Nasal 0.042MG/SPRAY IPRATROPIUM BROMIDE Novex | Atrovent HFA (ipratropium bromide HFA) Inhalation Aerosol, Boehringer, Approval | Ipratropium Bromide Inhalation Solution, Breath Ltd., Approval | Ipratropium Bromide Inhalation Solution, RxElite, Approval | DuoNeb (ipratropium bromide and albuterol sulfate) Inhalation Solution, Dey, Control Supplement | Atrovent HFA (ipratropium bromide HFA) Inhalation Aerosol, Boehringer Ingelheim, Labeling Revision | Combivent (ipratropium bromide/albuterol sulfate) Inhalation Aerosol, Boehringer Pharma, Labeling Revision | DuoNeb (ipratropium bromide and albuterol sulfate) Inhalation Aerosol, Dey, L.P., Labeling Revision | Ipratropium Bromide Inhalation Solution, Dey, Package Change
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