FDA.reportPublic FDA data

Application 209745

Type
ANDA
Sponsor
AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SILODOSINSILODOSINCAPSULE;ORAL4MGNoNo
002SILODOSINSILODOSINCAPSULE;ORAL8MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-777SilodosinSilodosinAvKAREANDACurrent
42291-778SilodosinSilodosinAvKAREANDACurrent
60219-1420SilodosinSilodosinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1421SilodosinSilodosinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1420SilodosinSilodosinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1420SilodosinSilodosinAmneal Pharmaceuticals LLCANDACurrent
69238-1420SilodosinSilodosinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1420SilodosinSilodosinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1420SilodosinSilodosinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1421SilodosinSilodosinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1421SilodosinSilodosinAmneal Pharmaceuticals LLCANDACurrent
69238-1421SilodosinSilodosinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1421SilodosinSilodosinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1421SilodosinSilodosinAmneal Pharmaceuticals NY LLCANDACurrent