FDA Approved Products

Application #TypeSponsorNotesProduct #Drug NameFormStrengthActive IngredientApproval DateMarketing StatusReference Standard
212097NDAXERIS003GVOKE HYPOPENSOLUTION;SUBCUTANEOUS0.5MG/0.1ML (0.5MG/0.1ML)GLUCAGON2019-09-10PrescriptionYes
004GVOKE HYPOPENSOLUTION;SUBCUTANEOUS1MG/0.2ML (1MG/0.2ML)GLUCAGON2019-09-10PrescriptionYes
005GVOKE KITSOLUTION;SUBCUTANEOUS1MG/0.2ML (1MG/0.2ML)GLUCAGON2019-09-10PrescriptionYes
001GVOKE PFSSOLUTION;SUBCUTANEOUS0.5MG/0.1ML (0.5MG/0.1ML)GLUCAGON2019-09-10DiscontinuedNo
002GVOKE PFSSOLUTION;SUBCUTANEOUS1MG/0.2ML (1MG/0.2ML)GLUCAGON2019-09-10PrescriptionYes
006GVOKE VIALDXSOLUTION;INTRAVENOUS1MG/0.2ML (1MG/0.2ML)GLUCAGON2019-09-10PrescriptionYes
011366NDAXERIS001DARANIDETABLET;ORAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**DICHLORPHENAMIDE1958-07-22DiscontinuedNo
002KEVEYISTABLET;ORAL50MGDICHLORPHENAMIDE1958-07-22PrescriptionYes