FDA.reportPublic FDA data

Application 212924

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FEBUXOSTATFEBUXOSTATTABLET;ORAL40MGNoNo
002FEBUXOSTATFEBUXOSTATTABLET;ORAL80MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67877-668FebuxostatFebuxostatAscend Laboratories, LLCANDACurrent
67877-668FebuxostatFebuxostatAscend Laboratories, LLCANDACurrent
67877-669FebuxostatFebuxostatAscend Laboratories, LLCANDACurrent
67877-669FebuxostatFebuxostatAscend Laboratories, LLCANDACurrent