FDA.reportPublic FDA data

Application 091048

Type
ANDA
Sponsor
SAGENT PHARMS INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66794-209CefepimeCefepimePiramal Critical Care Inc.ANDACurrent
66794-209CefepimeCefepimePiramal Critical Care Inc.ANDACurrent
66794-209CefepimeCefepimePiramal Critical Care Inc.ANDACurrent
66794-209CefepimeCefepimePiramal Critical Care Inc.ANDACurrent
66794-209CefepimeCefepimePiramal Critical Care Inc.ANDACurrent
66794-209CefepimeCefepimePiramal Critical Care Inc.ANDACurrent
66794-209CefepimeCefepimePiramal Critical Care Inc.ANDACurrent
66794-209CefepimeCefepimePiramal Critical Care Inc.ANDACurrent
66794-210CefepimeCefepimePiramal Critical Care Inc.ANDACurrent
66794-210CefepimeCefepimePiramal Critical Care Inc.ANDACurrent
66794-210CefepimeCefepimePiramal Critical Care Inc.ANDACurrent
66794-210CefepimeCefepimePiramal Critical Care Inc.ANDACurrent
66794-210CefepimeCefepimePiramal Critical Care Inc.ANDACurrent
66794-210CefepimeCefepimePiramal Critical Care Inc.ANDACurrent
66794-210CefepimeCefepimePiramal Critical Care Inc.ANDACurrent
66794-210CefepimeCefepimePiramal Critical Care Inc.ANDACurrent
71288-008Cefepimecefepime hydrochlorideMeitheal Pharmaceuticals Inc.ANDACurrent
71288-008Cefepimecefepime hydrochlorideMeitheal Pharmaceuticals Inc.ANDACurrent
71288-008Cefepimecefepime hydrochlorideMeitheal Pharmaceuticals Inc.ANDACurrent
71288-009Cefepimecefepime hydrochlorideMeitheal Pharmaceuticals Inc.ANDACurrent
71288-009Cefepimecefepime hydrochlorideMeitheal Pharmaceuticals Inc.ANDACurrent
71288-009Cefepimecefepime hydrochlorideMeitheal Pharmaceuticals Inc.ANDACurrent