FDA.reportPublic FDA data

Application 203704

Type
ANDA
Sponsor
QILU

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFEPIME HYDROCHLORIDECEFEPIME HYDROCHLORIDEINJECTABLE;INJECTIONEQ 500MG BASE/VIALNoNo
002CEFEPIME HYDROCHLORIDECEFEPIME HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo
003CEFEPIME HYDROCHLORIDECEFEPIME HYDROCHLORIDEINJECTABLE;INJECTIONEQ 2GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-6144CefepimeCefepimeApotex Corp.ANDACurrent
60505-6144CefepimeCefepimeApotex Corp.ANDACurrent
60505-6144CefepimeCefepimeApotex Corp.ANDACurrent
60505-6144CefepimeCefepimeApotex Corp.ANDACurrent
60505-6145CefepimeCefepimeApotex Corp.ANDACurrent
60505-6145CefepimeCefepimeApotex Corp.ANDACurrent
60505-6145CefepimeCefepimeApotex Corp.ANDACurrent
60505-6145CefepimeCefepimeApotex Corp.ANDACurrent
60505-6146CefepimeCefepimeApotex Corp.ANDACurrent
60505-6146CefepimeCefepimeApotex Corp.ANDACurrent
60505-6146CefepimeCefepimeApotex Corp.ANDACurrent
60505-6147CefepimeCefepimeApotex Corp.ANDACurrent
60505-6147CefepimeCefepimeApotex Corp.ANDACurrent
60505-6147CefepimeCefepimeApotex Corp.ANDACurrent
60505-6245CefepimeCefepimeApotex Corp.ANDACurrent
60505-6246CefepimeCefepimeApotex Corp.ANDACurrent
67184-1002CefepimeCEFEPIME HYDROCHLORIDEQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-1002CefepimeCEFEPIME HYDROCHLORIDEQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-1003CefepimeCEFEPIME HYDROCHLORIDEQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-1003CefepimeCEFEPIME HYDROCHLORIDEQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-1004CefepimeCEFEPIME HYDROCHLORIDEQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-1004CefepimeCEFEPIME HYDROCHLORIDEQilu Pharmaceutical Co., Ltd.ANDACurrent