FDA.reportPublic FDA data

Application 214559

Type
ANDA
Sponsor
AUCTA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
72647-371Deferasirox Oral GranulesdeferasiroxOAKRUM PHARMA, LLCANDACurrent
72647-371Deferasirox Oral GranulesdeferasiroxOAKRUM PHARMA, LLCANDACurrent
72647-371Deferasirox Oral GranulesdeferasiroxOAKRUM PHARMA, LLCANDACurrent
72647-372Deferasirox Oral GranulesdeferasiroxOAKRUM PHARMA, LLCANDACurrent
72647-372Deferasirox Oral GranulesdeferasiroxOAKRUM PHARMA, LLCANDACurrent
72647-372Deferasirox Oral GranulesdeferasiroxOAKRUM PHARMA, LLCANDACurrent
72647-373Deferasirox Oral GranulesdeferasiroxOAKRUM PHARMA, LLCANDACurrent
72647-373Deferasirox Oral GranulesdeferasiroxOAKRUM PHARMA, LLCANDACurrent
72647-373Deferasirox Oral GranulesdeferasiroxOAKRUM PHARMA, LLCANDACurrent