FDA.reportPublic FDA data

Application 065311

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFADROXILCEFADROXIL/CEFADROXIL HEMIHYDRATECAPSULE;ORALEQ 500MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9947CefadroxilCefadroxilHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9947CefadroxilCefadroxilWest-Ward PharmaceuticalsANDACurrent
0143-9947CefadroxilCefadroxilHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9947CefadroxilCefadroxilHikma Pharmaceuticals USA Inc.ANDACurrent
21695-427CefadroxilCefadroxilRebel Distributors CorpANDACurrent
49999-021CefadroxilCefadroxilLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0579CefadroxilCefadroxilA-S Medication SolutionsANDACurrent
68289-051CefadroxilCefadroxilJazeera PharmaceuticalANDACurrent