FDA.reportPublic FDA data

Application 208283

Type
ANDA
Sponsor
BRECKENRIDGE

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
51991-877EPLERENONEEPLERENONEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-877EPLERENONEEPLERENONEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-877EPLERENONEEPLERENONEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-877EPLERENONEEPLERENONEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-878EPLERENONEEPLERENONEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-878EPLERENONEEPLERENONEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-878EPLERENONEEPLERENONEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-878EPLERENONEEPLERENONEBreckenridge Pharmaceutical, Inc.ANDACurrent
60687-451EPLERENONEEPLERENONEAmerican Health PackagingANDACurrent
60687-451EPLERENONEEPLERENONEAmerican Health PackagingANDACurrent
60687-451EPLERENONEEPLERENONEAmerican Health PackagingANDACurrent