Application 078482

Type
ANDA
Sponsor
COREPHARMA

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
60505-2651EplerenoneEplerenoneApotex CorpANDACurrent
60505-2652EplerenoneEplerenoneApotex CorpANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9159ORIG2008-08-05