FDA.reportPublic FDA data

Application 090687

Type
ANDA
Sponsor
STRIDES PHARMA

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
0904-7097TacrolimusTacrolimusMajor PharmaceuticalsANDACurrent
0904-7097TacrolimusTacrolimusMajor PharmaceuticalsANDACurrent
64380-720TacrolimusTacrolimusStrides Pharma Science LimitedANDACurrent
64380-720TacrolimusTacrolimusStrides Shasun LimitedANDACurrent
64380-720TacrolimusTacrolimusStrides Pharma Science LimitedANDACurrent
64380-720TacrolimusTacrolimusStrides Pharma Science LimitedANDACurrent
64380-720TacrolimusTacrolimusStrides Pharma Science LimitedANDACurrent
64380-721TacrolimusTacrolimusStrides Pharma Science LimitedANDACurrent
64380-721TacrolimusTacrolimusStrides Pharma Science LimitedANDACurrent
64380-721TacrolimusTacrolimusStrides Pharma Science LimitedANDACurrent
64380-721TacrolimusTacrolimusStrides Pharma Science LimitedANDACurrent
64380-721TacrolimusTacrolimusStrides Pharma Science LimitedANDACurrent
64380-721TacrolimusTacrolimusStrides Shasun LimitedANDACurrent
64380-721TacrolimusTacrolimusStrides Pharma Science LimitedANDACurrent
64380-722TacrolimusTacrolimusStrides Pharma Science LimitedANDACurrent
64380-722TacrolimusTacrolimusStrides Shasun LimitedANDACurrent
64380-722TacrolimusTacrolimusStrides Pharma Science LimitedANDACurrent
64380-722TacrolimusTacrolimusStrides Pharma Science LimitedANDACurrent
64380-722TacrolimusTacrolimusStrides Pharma Science LimitedANDACurrent
70518-1168TacrolimusTacrolimusREMEDYREPACK INC.ANDACurrent
70518-1168TacrolimusTacrolimusREMEDYREPACK INC.ANDACurrent