FDA.reportPublic FDA data

Application 213112

Type
ANDA
Sponsor
CONCORD BIOTECH 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
68254-5004TacrolimusTacrolimusCONCORD BIOTECH LIMITEDANDACurrent
68254-5004TacrolimusTacrolimusCONCORD BIOTECH LIMITEDANDACurrent
68254-5004TacrolimusTacrolimusCONCORD BIOTECH LIMITEDANDACurrent
68254-5005TacrolimusTacrolimusCONCORD BIOTECH LIMITEDANDACurrent
68254-5005TacrolimusTacrolimusCONCORD BIOTECH LIMITEDANDACurrent
68254-5005TacrolimusTacrolimusCONCORD BIOTECH LIMITEDANDACurrent
68254-5006TacrolimusTacrolimusCONCORD BIOTECH LIMITEDANDACurrent
68254-5006TacrolimusTacrolimusCONCORD BIOTECH LIMITEDANDACurrent
68254-5006TacrolimusTacrolimusCONCORD BIOTECH LIMITEDANDACurrent
70748-219TacrolimusTacrolimusLupin Pharmaceuticals, Inc.ANDACurrent
70748-219TacrolimusTacrolimusLupin Pharmaceuticals, Inc.ANDACurrent
70748-219TacrolimusTacrolimusLupin Pharmaceuticals, Inc.ANDACurrent
70748-220TacrolimusTacrolimusLupin Pharmaceuticals, Inc.ANDACurrent
70748-220TacrolimusTacrolimusLupin Pharmaceuticals, Inc.ANDACurrent
70748-220TacrolimusTacrolimusLupin Pharmaceuticals, Inc.ANDACurrent
70748-221TacrolimusTacrolimusLupin Pharmaceuticals, Inc.ANDACurrent
70748-221TacrolimusTacrolimusLupin Pharmaceuticals, Inc.ANDACurrent
70748-221TacrolimusTacrolimusLupin Pharmaceuticals, Inc.ANDACurrent