Application 210555

Type
ANDA
Sponsor
ALKEM LABS LTD

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
67877-552DeferasiroxDeferasiroxAscend Laboratories, LLCANDACurrent
67877-552DeferasiroxDeferasiroxAscend Laboratories, LLCANDACurrent
67877-552DeferasiroxDeferasiroxAscend Laboratories, LLCANDACurrent
67877-552DeferasiroxDeferasiroxAscend Laboratories, LLCANDACurrent
67877-552DeferasiroxDeferasiroxAscend Laboratories, LLCANDACurrent
67877-553DeferasiroxDeferasiroxAscend Laboratories, LLCANDACurrent
67877-553DeferasiroxDeferasiroxAscend Laboratories, LLCANDACurrent
67877-553DeferasiroxDeferasiroxAscend Laboratories, LLCANDACurrent
67877-553DeferasiroxDeferasiroxAscend Laboratories, LLCANDACurrent
67877-554DeferasiroxDeferasiroxAscend Laboratories, LLCANDACurrent
67877-554DeferasiroxDeferasiroxAscend Laboratories, LLCANDACurrent
67877-554DeferasiroxDeferasiroxAscend Laboratories, LLCANDACurrent
67877-554DeferasiroxDeferasiroxAscend Laboratories, LLCANDACurrent
67877-554DeferasiroxDeferasiroxAscend Laboratories, LLCANDACurrent