FDA.reportPublic FDA data

Application 203896

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPLERENONEEPLERENONETABLET;ORAL25MGNoNo
002EPLERENONEEPLERENONETABLET;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-1030EplerenoneeplerenoneMylan Pharmaceuticals Inc.ANDACurrent
0378-1030EplerenoneeplerenoneMylan Pharmaceuticals Inc.ANDACurrent
0378-1030EplerenoneeplerenoneMylan Pharmaceuticals Inc.ANDACurrent
0378-1030EplerenoneeplerenoneMylan Pharmaceuticals Inc.ANDACurrent
0378-1031EplerenoneeplerenoneMylan Pharmaceuticals Inc.ANDACurrent
0378-1031EplerenoneeplerenoneMylan Pharmaceuticals Inc.ANDACurrent
0378-1031EplerenoneeplerenoneMylan Pharmaceuticals Inc.ANDACurrent
0378-1031EplerenoneeplerenoneMylan Pharmaceuticals Inc.ANDACurrent
66993-343EplerenoneeplerenonePrasco LaboratoriesANDACurrent
66993-344EplerenoneeplerenonePrasco LaboratoriesANDACurrent