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Application Number Application Type Drug Name Active Ingredients Dosage Form/Route Approval Date Company
216667 ANDA BUDESONIDE BUDESONIDE SUSPENSION;INHALATION EUGIA PHARMA
215935 NDA TARPEYO BUDESONIDE CAPSULE, DELAYED RELEASE;ORAL 2021-12-15 CALLIDITAS
215328 ANDA BUDESONIDE BUDESONIDE AEROSOL, FOAM;RECTAL 2023-04-12 PADAGIS ISRAEL
213976 NDA EOHILIA BUDESONIDE SUSPENSION;ORAL TAKEDA PHARMS USA
211929 NDA ORTIKOS BUDESONIDE CAPSULE, DELAYED RELEASE;ORAL 2019-06-13 SUN PHARM INDS INC
211922 ANDA BUDESONIDE BUDESONIDE SUSPENSION;INHALATION 2021-04-14 SUN PHARM
210897 ANDA BUDESONIDE BUDESONIDE SUSPENSION;INHALATION 2018-11-09 LUPIN
209041 ANDA BUDESONIDE BUDESONIDE CAPSULE, DELAYED RELEASE;ORAL 2017-09-28 SCIECURE PHARMA INC
208851 ANDA BUDESONIDE BUDESONIDE TABLET, EXTENDED RELEASE;ORAL 2020-09-17 MYLAN
207367 ANDA BUDESONIDE BUDESONIDE CAPSULE, DELAYED RELEASE;ORAL 2017-04-07 RISING
206724 ANDA BUDESONIDE BUDESONIDE CAPSULE, DELAYED RELEASE;ORAL 2016-11-23 NATCO
206623 ANDA BUDESONIDE BUDESONIDE CAPSULE, DELAYED RELEASE;ORAL 2016-04-08 DR REDDYS LABS SA
206200 ANDA BUDESONIDE BUDESONIDE CAPSULE, DELAYED RELEASE;ORAL 2017-07-31 AMNEAL PHARMS
206134 ANDA BUDESONIDE BUDESONIDE CAPSULE, DELAYED RELEASE;ORAL 2017-05-04 ZYDUS PHARMS
205710 ANDA BUDESONIDE BUDESONIDE SUSPENSION;INHALATION 2017-11-16 CIPLA
205613 NDA UCERIS BUDESONIDE AEROSOL, FOAM;RECTAL 2014-10-07 SALIX
205457 ANDA BUDESONIDE BUDESONIDE TABLET, EXTENDED RELEASE;ORAL 2018-07-03 ACTAVIS LABS FL INC
204548 ANDA BUDESONIDE BUDESONIDE SUSPENSION;INHALATION 2016-03-08 TEVA PHARMS USA
203634 NDA UCERIS BUDESONIDE TABLET, EXTENDED RELEASE;ORAL 2013-01-14 SALIX
201966 ANDA BUDESONIDE BUDESONIDE SUSPENSION;INHALATION 2013-09-27 SANDOZ