FDA.reportPublic FDA data

Application 201071

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
0378-0353NifedipinenifedipineMylan Pharmaceuticals Inc.ANDACurrent
0378-0360NifedipinenifedipineMylan Pharmaceuticals Inc.ANDACurrent
0378-0390NifedipinenifedipineMylan Pharmaceuticals Inc.ANDACurrent
43353-750NifedipinenifedipineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-750NifedipinenifedipineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-836NifedipinenifedipineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-836NifedipinenifedipineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-929NifedipinenifedipineAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-2917NifedipinenifedipineA-S Medication SolutionsANDACurrent
70518-0747NifedipinenifedipineREMEDYREPACK INC.ANDACurrent
70518-0747NifedipinenifedipineREMEDYREPACK INC.ANDACurrent