FDA.reportPublic FDA data

Application 065444

Type
ANDA
Sponsor
HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEPHALEXINCEPHALEXINFOR SUSPENSION;ORALEQ 125MG BASE/5MLNoNo
002CEPHALEXINCEPHALEXINFOR SUSPENSION;ORALEQ 250MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9769CephalexinCephalexinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9769CephalexinCephalexinWest-ward Pharmaceutical ANDACurrent
0143-9769CephalexinCephalexinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9769CephalexinCephalexinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9770CephalexinCephalexinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9770CephalexinCephalexinWest-ward Pharmaceutical ANDACurrent
0143-9770CephalexinCephalexinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9770CephalexinCephalexinHikma Pharmaceuticals USA Inc.ANDACurrent
68289-008CephalexinCephalexinJazeera PharmaceuticalANDACurrent
68289-009CephalexinCephalexinJazeera PharmaceuticalANDACurrent