FDA.reportPublic FDA data

Application 090649

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NIFEDIPINENIFEDIPINETABLET, EXTENDED RELEASE;ORAL30MGNoNo
002NIFEDIPINENIFEDIPINETABLET, EXTENDED RELEASE;ORAL60MGNoNo
003NIFEDIPINENIFEDIPINETABLET, EXTENDED RELEASE;ORAL90MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0480NifedipinenifedipineMylan Pharmaceuticals Inc.ANDACurrent
0378-0480NifedipinenifedipineMylan Pharmaceuticals IncANDACurrent
0378-0481NifedipinenifedipineMylan Pharmaceuticals IncANDACurrent
0378-0481NifedipinenifedipineMylan Pharmaceuticals Inc.ANDACurrent
0378-0494NifedipinenifedipineMylan Pharmaceuticals IncANDACurrent
0378-0494NifedipinenifedipineMylan Pharmaceuticals Inc.ANDACurrent
0615-5541NifedipinenifedipineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-6563NifedipinenifedipineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7571NifedipineNifedipineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
51079-400NifedipinenifedipineMylan Institutional Inc.ANDACurrent
51079-896NifedipinenifedipineMylan Institutional Inc.ANDACurrent
51079-897NifedipinenifedipineMylan Institutional Inc.ANDACurrent
55154-5363NifedipinenifedipineCardinal HealthANDACurrent
55154-5363NifedipinenifedipineCardinal HealthANDACurrent
55154-5368NifedipinenifedipineCardinal HealthANDACurrent
55154-5368NifedipinenifedipineCardinal HealthANDACurrent
68788-9885NifedipinenifedipinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9886NifedipinenifedipinePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0960NifedipinenifedipineREMEDYREPACK INC.ANDACurrent
70518-0960NifedipinenifedipineREMEDYREPACK INC.ANDACurrent