FDA.reportPublic FDA data

Application 204589

Type
ANDA
Sponsor
AKORN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPTIFIBATIDEEPTIFIBATIDEINJECTABLE;INJECTION2MG/MLNoNo
002EPTIFIBATIDEEPTIFIBATIDEINJECTABLE;INJECTION75MG/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-902EptifibatideEptifibatideAkorn, Inc.ANDACurrent
17478-902EptifibatideEptifibatideAkorn, Inc.ANDACurrent
17478-902EptifibatideEptifibatideAkornANDACurrent
17478-902EptifibatideEptifibatideAkorn, Inc.ANDACurrent
17478-903EptifibatideEptifibatideAkorn, Inc.ANDACurrent
17478-903EptifibatideEptifibatideAkorn, Inc.ANDACurrent
17478-903EptifibatideEptifibatideAkornANDACurrent
17478-903EptifibatideEptifibatideAkorn, Inc.ANDACurrent