FDA.reportPublic FDA data

Application 205557

Type
ANDA
Sponsor
ACCORD HLTHCARE

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
16729-259EPTIFIBATIDEEptifibatideAccord Healthcare Inc.ANDACurrent
16729-259EPTIFIBATIDEEptifibatideAccord Healthcare Inc.ANDACurrent
16729-260EPTIFIBATIDEEptifibatideAccord Healthcare Inc.ANDACurrent
16729-260EPTIFIBATIDEEptifibatideAccord Healthcare Inc.ANDACurrent