Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.