FDA.reportPublic FDA data

Application 203740

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TACROLIMUSTACROLIMUSCAPSULE;ORALEQ 0.5MG BASENoNo
002TACROLIMUSTACROLIMUSCAPSULE;ORALEQ 1MG BASENoNo
003TACROLIMUSTACROLIMUSCAPSULE;ORALEQ 5MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67877-278TacrolimusTacrolimusAscend Laboratories, LLCANDACurrent
67877-278TacrolimusTacrolimusAscend Laboratories, LLCANDACurrent
67877-278TacrolimusTacrolimusAscend Laboratories, LLCANDACurrent
67877-279TacrolimusTacrolimusAscend Laboratories, LLCANDACurrent
67877-279TacrolimusTacrolimusAscend Laboratories, LLCANDACurrent
67877-279TacrolimusTacrolimusAscend Laboratories, LLCANDACurrent
67877-280TacrolimusTacrolimusAscend Laboratories, LLCANDACurrent
67877-280TacrolimusTacrolimusAscend Laboratories, LLCANDACurrent
67877-280TacrolimusTacrolimusAscend Laboratories, LLCANDACurrent