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Application 205581

Type
ANDA
Sponsor
AMNEAL PHARMS

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
70121-1002EptifibatideEptifibatideAmneal Pharmaceuticals LLCANDACurrent
70121-1002EptifibatideEptifibatideAmneal Pharmaceuticals LLCANDACurrent
70121-1002EptifibatideEptifibatideAmneal BiosciencesANDACurrent
70121-1002EptifibatideEptifibatideAmneal Pharmaceuticals LLCANDACurrent
70121-1002EptifibatideEptifibatideAmneal Pharmaceuticals LLCANDACurrent
70121-1003EptifibatideEptifibatideAmneal Pharmaceuticals LLCANDACurrent
70121-1003EptifibatideEptifibatideAmneal Pharmaceuticals LLCANDACurrent
70121-1003EptifibatideEptifibatideAmneal BiosciencesANDACurrent
70121-1003EptifibatideEptifibatideAmneal Pharmaceuticals LLCANDACurrent
70121-1003EptifibatideEptifibatideAmneal Pharmaceuticals LLCANDACurrent