FDA.reportPublic FDA data

Application 209864

Type
ANDA
Sponsor
HAINAN POLY PHARM

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
14335-070EptifibatideeptifibatideHainan Poly Pharm. Co., Ltd.ANDACurrent
14335-070EptifibatideeptifibatideHainan Poly Pharm. Co., Ltd.ANDACurrent
14335-071EptifibatideeptifibatideHainan Poly Pharm. Co., Ltd.ANDACurrent
14335-071EptifibatideeptifibatideHainan Poly Pharm. Co., Ltd.ANDACurrent
70436-026EptifibatideeptifibatideSlate Run Pharmaceuticals, LLCANDACurrent
70436-026EptifibatideeptifibatideSlate Run Pharmaceuticals, LLCANDACurrent
70436-026EptifibatideeptifibatideSlate Run Pharmaceuticals, LLCANDACurrent
70436-026EptifibatideeptifibatideSlate Run Pharmaceuticals, LLCANDACurrent
70436-027EptifibatideeptifibatideSlate Run Pharmaceuticals, LLCANDACurrent
70436-027EptifibatideeptifibatideSlate Run Pharmaceuticals, LLCANDACurrent
70436-027EptifibatideeptifibatideSlate Run Pharmaceuticals, LLCANDACurrent
70436-027EptifibatideeptifibatideSlate Run Pharmaceuticals, LLCANDACurrent
70436-162EptifibatideeptifibatideSlate Run Pharmaceuticals, LLCANDACurrent
70436-162EptifibatideeptifibatideSlate Run Pharmaceuticals, LLCANDACurrent
70436-162EptifibatideeptifibatideSlate Run Pharmaceuticals, LLCANDACurrent
70436-163EptifibatideeptifibatideSlate Run Pharmaceuticals, LLCANDACurrent
70436-163EptifibatideeptifibatideSlate Run Pharmaceuticals, LLCANDACurrent
70436-163EptifibatideeptifibatideSlate Run Pharmaceuticals, LLCANDACurrent