FDA.reportPublic FDA data

Application 214138

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EVEROLIMUSEVEROLIMUSTABLET;ORAL0.25MGNoNo
002EVEROLIMUSEVEROLIMUSTABLET;ORAL0.5MGNoNo
003EVEROLIMUSEVEROLIMUSTABLET;ORAL0.75MGNoNo
004EVEROLIMUSEVEROLIMUSTABLET;ORAL1MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67877-718EverolimusEverolimusAscend Laboratories, LLCANDACurrent
67877-718EverolimusEverolimusAscend Laboratories, LLCANDACurrent
67877-719EverolimusEverolimusAscend Laboratories, LLCANDACurrent
67877-719EverolimusEverolimusAscend Laboratories, LLCANDACurrent
67877-720EverolimusEverolimusAscend Laboratories, LLCANDACurrent
67877-720EverolimusEverolimusAscend Laboratories, LLCANDACurrent
67877-721EverolimusEverolimusAscend Laboratories, LLCANDACurrent
67877-721EverolimusEverolimusAscend Laboratories, LLCANDACurrent