FDA Approved Products

Application #TypeSponsorNotesProduct #Drug NameFormStrengthActive IngredientApproval DateMarketing StatusReference Standard
218980NDAETON001KHINDIVISOLUTION;ORAL1MG/MLHYDROCORTISONE2025-05-28PrescriptionYes
216201ANDAETON001NITISINONECAPSULE;ORAL2MGNITISINONE2023-05-25PrescriptionNo
002NITISINONECAPSULE;ORAL5MGNITISINONE2023-05-25PrescriptionNo
003NITISINONECAPSULE;ORAL10MGNITISINONE2023-05-25PrescriptionNo
004NITISINONECAPSULE;ORAL20MGNITISINONE2023-05-25PrescriptionNo
210508ANDAETON001BETAINEFOR SOLUTION;ORAL1GM/SCOOPFULBETAINE2022-01-28PrescriptionNo
213876NDAETON001ALKINDI SPRINKLEGRANULE;ORAL0.5MGHYDROCORTISONE2020-09-29PrescriptionNo
002ALKINDI SPRINKLEGRANULE;ORAL1MGHYDROCORTISONE2020-09-29PrescriptionNo
003ALKINDI SPRINKLEGRANULE;ORAL2MGHYDROCORTISONE2020-09-29PrescriptionNo
004ALKINDI SPRINKLEGRANULE;ORAL5MGHYDROCORTISONE2020-09-29PrescriptionYes
020458NDAETON001GALZINCAPSULE;ORALEQ 25MG ZINCZINC ACETATE1997-01-28PrescriptionNo
002GALZINCAPSULE;ORALEQ 50MG ZINCZINC ACETATE1997-01-28PrescriptionYes