FDA.reportPublic FDA data

Application 064125

Type
ANDA
Sponsor
ACS DOBFAR SPA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFUROXIME SODIUMCEFUROXIME SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 750MG BASE/VIALNoNo
002CEFUROXIME SODIUMCEFUROXIME SODIUMINJECTABLE;INJECTIONEQ 1.5GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25021-118Cefuroxime sodiumCefuroxime sodiumSagent PharmaceuticalsANDACurrent
25021-118Cefuroxime sodiumCefuroxime sodiumSagent PharmaceuticalsANDACurrent
25021-118Cefuroxime SodiumCefuroxime SodiumSagent PharmaceuticalsANDACurrent
25021-118Cefuroxime sodiumCefuroxime sodiumSagent PharmaceuticalsANDACurrent
25021-119Cefuroxime sodiumCefuroxime sodiumSagent PharmaceuticalsANDACurrent
25021-119Cefuroxime sodiumCefuroxime sodiumSagent PharmaceuticalsANDACurrent
25021-119Cefuroxime SodiumCefuroxime SodiumSagent PharmaceuticalsANDACurrent
25021-119Cefuroxime sodiumCefuroxime sodiumSagent PharmaceuticalsANDACurrent
25021-182Cefuroxime sodiumCefuroxime sodiumSagent PharmaceuticalsANDACurrent
25021-182Cefuroxime SodiumCefuroxime SodiumSagent PharmaceuticalsANDACurrent
25021-183Cefuroxime sodiumCefuroxime sodiumSagent PharmaceuticalsANDACurrent
25021-183Cefuroxime SodiumCefuroxime SodiumSagent PharmaceuticalsANDACurrent
44567-710CefuroximeCefuroximeWG Critical Care, LLCANDACurrent
44567-711CefuroximeCefuroximeWG Critical Care, LLCANDACurrent
44567-720CefuroximeCefuroximeWG Critical Care, LLCANDACurrent
44567-722CefuroximeCefuroximeWG Critical Care, LLCANDACurrent