FDA.reportPublic FDA data

Application 090596

Type
ANDA
Sponsor
MYLAN

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
0378-2045TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
0378-2045TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
0378-2045TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
0378-2045TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
0378-2045TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
0378-2045TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
0378-2045TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
0378-2045TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
0378-2046TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
0378-2046TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
0378-2046TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
0378-2046TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
0378-2046TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
0378-2046TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
0378-2046TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
0378-2046TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
0378-2047TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
0378-2047TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
0378-2047TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
0378-2047TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
0378-2047TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
0378-2047TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
0378-2047TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
0378-2047TacrolimusTacrolimusMylan Pharmaceuticals Inc.ANDACurrent
43353-317TacrolimusTacrolimusAphena Pharma Solutions - Tennessee, LLCANDACurrent
51079-028TacrolimusTacrolimusMylan Institutional Inc.ANDACurrent
51079-028TacrolimusTacrolimusMylan Institutional Inc.ANDACurrent
51079-028TacrolimusTacrolimusMylan Institutional Inc.ANDACurrent
51079-028TacrolimusTacrolimusMylan Institutional Inc.ANDACurrent
51079-028TacrolimusTacrolimusMylan Institutional Inc.ANDACurrent
51079-028TacrolimusTacrolimusMylan Institutional Inc.ANDACurrent
51079-817TacrolimusTacrolimusMylan Institutional Inc.ANDACurrent
51079-817TacrolimusTacrolimusMylan Institutional Inc.ANDACurrent
51079-817TacrolimusTacrolimusMylan Institutional Inc.ANDACurrent
51079-817TacrolimusTacrolimusMylan Institutional Inc.ANDACurrent
51079-817TacrolimusTacrolimusMylan Institutional Inc.ANDACurrent
51079-817TacrolimusTacrolimusMylan Institutional Inc.ANDACurrent
51079-818TacrolimusTacrolimusMylan Institutional Inc.ANDACurrent
51079-818TacrolimusTacrolimusMylan Institutional Inc.ANDACurrent
51079-818TacrolimusTacrolimusMylan Institutional Inc.ANDACurrent
51079-818TacrolimusTacrolimusMylan Institutional Inc.ANDACurrent
51079-818TacrolimusTacrolimusMylan Institutional Inc.ANDACurrent
51079-818TacrolimusTacrolimusMylan Institutional Inc.ANDACurrent
55154-4395TacrolimusTacrolimusCardinal HealthANDACurrent
55154-4395TacrolimusTacrolimusCardinal HealthANDACurrent
55154-4395TacrolimusTacrolimusCardinal HealthANDACurrent
60429-377TacrolimusTacrolimusGolden State Medical Supply, Inc.ANDACurrent
60429-377TacrolimusTacrolimusGolden State Medical Supply, Inc.ANDACurrent
60429-377TacrolimusTacrolimusGolden State Medical SupplyANDACurrent
60429-377TacrolimusTacrolimusGolden State Medical Supply, Inc.ANDACurrent
60429-377TacrolimusTacrolimusGolden State Medical Supply, Inc.ANDACurrent
60429-378TacrolimusTacrolimusGolden State Medical Supply, Inc.ANDACurrent
60429-378TacrolimusTacrolimusGolden State Medical Supply, Inc.ANDACurrent
60429-378TacrolimusTacrolimusGolden State Medical SupplyANDACurrent
60429-378TacrolimusTacrolimusGolden State Medical Supply, Inc.ANDACurrent
60429-378TacrolimusTacrolimusGolden State Medical Supply, Inc.ANDACurrent
60429-379TacrolimusTacrolimusGolden State Medical Supply, Inc.ANDACurrent
60429-379TacrolimusTacrolimusGolden State Medical Supply, Inc.ANDACurrent
60429-379TacrolimusTacrolimusGolden State Medical SupplyANDACurrent
60429-379TacrolimusTacrolimusGolden State Medical Supply, Inc.ANDACurrent
60429-379TacrolimusTacrolimusGolden State Medical Supply, Inc.ANDACurrent