FDA.reportPublic FDA data

Application 214753

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SIROLIMUSSIROLIMUSTABLET;ORAL0.5MGNoNo
002SIROLIMUSSIROLIMUSTABLET;ORAL1MGNoNo
003SIROLIMUSSIROLIMUSTABLET;ORAL2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7248SirolimusSirolimusMajor PharmaceuticalsANDACurrent
67877-746SirolimusSirolimusAscend Laboratories, LLCANDACurrent
67877-746SirolimusSirolimusAscend Laboratories, LLCANDACurrent
67877-747SirolimusSirolimusAscend Laboratories, LLCANDACurrent
67877-747SirolimusSirolimusAscend Laboratories, LLCANDACurrent
67877-748SirolimusSirolimusAscend Laboratories, LLCANDACurrent
67877-748SirolimusSirolimusAscend Laboratories, LLCANDACurrent
70518-3546SirolimusSirolimusREMEDYREPACK INC.ANDACurrent
70518-3547SirolimusSirolimusREMEDYREPACK INC.ANDACurrent