FDA.reportPublic FDA data

Application 065046

Type
ANDA
Sponsor
HIKMA FARMACEUTICA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFUROXIME SODIUMCEFUROXIME SODIUMINJECTABLE;INJECTIONEQ 7.5GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9569CefuroximeCefuroximeWest-Ward Pharmaceuticals CorpANDACurrent
0143-9569CefuroximeCefuroximeHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9976CefuroximeCefuroximeWest-Ward Pharmaceuticals CorpANDACurrent
0143-9976CefuroximeCefuroximeHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9976CefuroximeCefuroximeHikma Pharmaceuticals USA Inc.ANDACurrent