FDA Approved Products

Application #TypeSponsorNotesProduct #Drug NameFormStrengthActive IngredientApproval DateMarketing StatusReference Standard
213931NDAARDELYX INC001XPHOZAHTABLET;ORALEQ 10MG BASETENAPANOR HYDROCHLORIDE2023-10-17DiscontinuedNo
002XPHOZAHTABLET;ORALEQ 20MG BASETENAPANOR HYDROCHLORIDE2023-10-17PrescriptionNo
003XPHOZAHTABLET;ORALEQ 30MG BASETENAPANOR HYDROCHLORIDE2023-10-17PrescriptionYes
211801NDAARDELYX INC001IBSRELATABLET;ORALEQ 50MG BASETENAPANOR HYDROCHLORIDE2019-09-12PrescriptionYes