FDA.reportPublic FDA data

Application 206651

Type
ANDA
Sponsor
BELCHER

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
42291-752TacrolimusTacrolimusAvKAREANDACurrent
42291-752TacrolimusTacrolimusAvKAREANDACurrent
42291-753TacrolimusTacrolimus CapsulesAvKAREANDACurrent
42291-753TacrolimusTacrolimus CapsulesAvKAREANDACurrent
42291-753TacrolimusTacrolimus CapsulesAvKAREANDACurrent
42291-754TacrolimusTacrolimus CapsulesAvKAREANDACurrent
42291-754TacrolimusTacrolimus CapsulesAvKAREANDACurrent
42291-754TacrolimusTacrolimus CapsulesAvKAREANDACurrent
54288-135TacrolimusTacrolimusBPI LABS LLCANDACurrent
54288-135TacrolimusTacrolimusBPI LABS LLCANDACurrent
54288-135TacrolimusTacrolimusBPI LABS LLCANDACurrent
54288-135TacrolimusTacrolimusBPI LABS LLCANDACurrent
54288-135TacrolimusTacrolimusBPI LABS LLCANDACurrent
54288-135TacrolimusTacrolimusBPI LABS LLCANDACurrent
54288-135TacrolimusTacrolimusBPI LABS LLCANDACurrent
62250-665TacrolimusTacrolimusBelcher Pharmaceuticals,LLCANDACurrent
62250-665TacrolimusTacrolimusBelcher Pharmaceuticals,LLCANDACurrent
62250-665TacrolimusTacrolimusBelcher Pharmaceuticals,LLCANDACurrent
62250-665TacrolimusTacrolimusBelcher Pharmaceuticals,LLCANDACurrent
62250-665TacrolimusTacrolimusBelcher Pharmaceuticals,LLCANDACurrent
62250-666TacrolimusTacrolimus CapsulesBelcher Pharmaceuticals,LLCANDACurrent
62250-666TacrolimusTacrolimus CapsulesBelcher Pharmaceuticals,LLCANDACurrent
62250-666TacrolimusTacrolimus CapsulesBelcher Pharmaceuticals,LLCANDACurrent
62250-666TacrolimusTacrolimus CapsulesBelcher Pharmaceuticals,LLCANDACurrent
62250-666TacrolimusTacrolimus CapsulesBelcher Pharmaceuticals,LLCANDACurrent
62250-667TacrolimusTacrolimus CapsulesBelcher Pharmaceuticals,LLCANDACurrent
62250-667TacrolimusTacrolimus CapsulesBelcher Pharmaceuticals,LLCANDACurrent
62250-667TacrolimusTacrolimus CapsulesBelcher Pharmaceuticals,LLCANDACurrent
62250-667TacrolimusTacrolimus CapsulesBelcher Pharmaceuticals,LLCANDACurrent
62250-667TacrolimusTacrolimus CapsulesBelcher Pharmaceuticals,LLCANDACurrent
70518-3388TacrolimusTacrolimusREMEDYREPACK INC.ANDACurrent