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Application Number Application Type Drug Name Active Ingredients Dosage Form/Route Approval Date Company
212827 ANDA GEFITINIB GEFITINIB TABLET;ORAL 2020-07-22 NATCO
211591 ANDA GEFITINIB GEFITINIB TABLET;ORAL 2023-02-13 QILU PHARM HAINAN
209532 ANDA GEFITINIB GEFITINIB TABLET;ORAL 2022-09-23 APOTEX
208913 ANDA GEFITINIB GEFITINIB TABLET;ORAL 2023-04-26 ACTAVIS LABS FL INC
206995 NDA IRESSA GEFITINIB TABLET;ORAL 2015-07-13 ASTRAZENECA
021399 NDA IRESSA GEFITINIB TABLET;ORAL 2003-05-05 ASTRAZENECA