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Application Number Application Type Drug Name Active Ingredients Dosage Form/Route Approval Date Company
211897 ANDA APREMILAST APREMILAST TABLET;ORAL 2022-08-18 TEVA PHARMS USA INC
211878 ANDA APREMILAST APREMILAST TABLET;ORAL 2019-06-24 ANNORA
211859 ANDA APREMILAST APREMILAST TABLET;ORAL 2022-02-03 ZYDUS PHARMS
211819 ANDA APREMILAST APREMILAST TABLET;ORAL 2021-02-17 UNICHEM
211782 ANDA APREMILAST APREMILAST TABLET;ORAL 2021-06-30 AMNEAL
211774 ANDA APREMILAST APREMILAST TABLET;ORAL 2023-04-07 SHILPA
211761 ANDA APREMILAST APREMILAST TABLET;ORAL 2021-09-21 ALKEM LABS LTD
211756 ANDA APREMILAST APREMILAST TABLET;ORAL 2019-11-15 DR REDDYS
211734 ANDA APREMILAST APREMILAST TABLET;ORAL 2019-04-18 MANKIND PHARMA
211716 ANDA APREMILAST APREMILAST TABLET;ORAL AUROBINDO PHARMA LTD
211674 ANDA APREMILAST APREMILAST TABLET;ORAL 2020-12-29 GLENMARK PHARMS LTD
206088 NDA OTEZLA APREMILAST TABLET;ORAL 2014-09-23 CELGENE CORP
205437 NDA OTEZLA APREMILAST TABLET;ORAL 2014-03-21 AMGEN INC