FDA.reportPublic FDA data

Application 214194

Type
ANDA
Sponsor
AMNEAL

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69238-1702deferasiroxdeferasiroxAmneal Pharmaceuticals NY LLCANDACurrent
69238-1702deferasiroxdeferasiroxAmneal Pharmaceuticals NY LLCANDACurrent
69238-1703deferasiroxdeferasiroxAmneal Pharmaceuticals NY LLCANDACurrent
69238-1703deferasiroxdeferasiroxAmneal Pharmaceuticals NY LLCANDACurrent
69238-1703deferasiroxdeferasiroxAmneal Pharmaceuticals NY LLCANDACurrent
69238-1704deferasiroxdeferasiroxAmneal Pharmaceuticals NY LLCANDACurrent
69238-1704deferasiroxdeferasiroxAmneal Pharmaceuticals NY LLCANDACurrent
69238-1704deferasiroxdeferasiroxAmneal Pharmaceuticals NY LLCANDACurrent