Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 | Albuterol Sulfate & Ipratropium Bromide Injection, Breath Ltd., Tentative Approval | Albuterol Sulfate and Ipratropium Bromide Inhalation Solution, Apotex, Tentative Approval | Albuterol Sulfate and Ipratropium Bromide Inhalation Solution, Nephron Pharma, Tentative Approval | Atrovent (ipratropium bromide) Nasal Spray, Boehringer Ingelheim, Labeling Revision | Atrovent (ipratropium bromide) Nasal Spray, Boehringer Ingelheim, Labeling Revision | Atrovent HFA (ipratropium bromide) Inhalation Aerosol, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision | Combivent (ipratropium bromide and albuterol sulfate) Inhalation Aerosol, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com