FDA.reportPublic FDA data

Application 091036

Type
ANDA
Sponsor
HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFADROXILCEFADROXIL/CEFADROXIL HEMIHYDRATEFOR SUSPENSION;ORALEQ 250MG BASE/5MLNoNo
002CEFADROXILCEFADROXIL/CEFADROXIL HEMIHYDRATEFOR SUSPENSION;ORALEQ 500MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9766CefadroxilCefadroxilHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9766CefadroxilCefadroxilHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9766CefadroxilCefadroxilWest-Ward PharmaceuticalsANDACurrent
0143-9767CefadroxilCefadroxilHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9767CefadroxilCefadroxilHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9767CefadroxilCefadroxilWest-Ward PharmaceuticalsANDACurrent
68289-013CefadroxilCefadroxilJazeera PharmaceuticalANDACurrent
68289-014CefadroxilCefadroxilJazeera PharmaceuticalANDACurrent