FDA.reportPublic FDA data

Application 206922

Type
ANDA
Sponsor
ACCORD HLTHCARE

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
16729-293EplerenoneEplerenoneAccord Healthcare, Inc.ANDACurrent
16729-293EplerenoneEplerenoneAccord Healthcare, Inc.ANDACurrent
16729-293EplerenoneEplerenoneAccord Healthcare, Inc.ANDACurrent
16729-294EplerenoneEplerenoneAccord Healthcare, Inc.ANDACurrent
16729-294EplerenoneEplerenoneAccord Healthcare, Inc.ANDACurrent
16729-294EplerenoneEplerenoneAccord Healthcare, Inc.ANDACurrent
63629-9414EplerenoneEplerenoneBryant Ranch PrepackANDACurrent