FDA.reportPublic FDA data

Application 210727

Type
ANDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEFERASIROXDEFERASIROXTABLET;ORAL90MGNoNo
002DEFERASIROXDEFERASIROXTABLET;ORAL360MGNoNo
003DEFERASIROXDEFERASIROXTABLET;ORAL180MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69238-1486DeferasiroxDeferasiroxAmneal Pharmaceuticals NY LLCANDACurrent
69238-1486DeferasiroxDeferasiroxAmneal Pharmaceuticals NY LLCANDACurrent
69238-1486DeferasiroxDeferasiroxAmneal Pharmaceuticals NY LLCANDACurrent
69238-1486DeferasiroxDeferasiroxAmneal Pharmaceuticals NY LLCANDACurrent
69238-1487DeferasiroxDeferasiroxAmneal Pharmaceuticals NY LLCANDACurrent
69238-1487DeferasiroxDeferasiroxAmneal Pharmaceuticals NY LLCANDACurrent
69238-1487DeferasiroxDeferasiroxAmneal Pharmaceuticals NY LLCANDACurrent
69238-1488DeferasiroxDeferasiroxAmneal Pharmaceuticals NY LLCANDACurrent
69238-1488DeferasiroxDeferasiroxAmneal Pharmaceuticals NY LLCANDACurrent
69238-1488DeferasiroxDeferasiroxAmneal Pharmaceuticals NY LLCANDACurrent
69238-1488DeferasiroxDeferasiroxAmneal Pharmaceuticals NY LLCANDACurrent