FDA.reportPublic FDA data

Application 213081

Type
ANDA
Sponsor
SHUANGCHENG

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
52958-040EptifibatideEptifibatideHainan Shuangcheng Pharmaceuticals Co., Ltd.ANDACurrent
52958-402EptifibatideEptifibatideHainan Shuangcheng Pharmaceuticals Co., Ltd.ANDACurrent
52958-402EptifibatideEptifibatideHainan Shuangcheng Pharmaceuticals Co., Ltd.ANDACurrent
70860-303EptifibatideeptifibatideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-303EptifibatideeptifibatideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-303EptifibatideeptifibatideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-305EptifibatideeptifibatideAthenex Pharmaceutical Division, LLC.ANDACurrent