FDA.reportPublic FDA data

Application 065350

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFACLORCEFACLORCAPSULE;ORALEQ 250MG BASENoNo
002CEFACLORCEFACLORCAPSULE;ORALEQ 500MG BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9985CEFACLORCEFACLORHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9985CEFACLORCEFACLORWest-Ward Pharmaceuticals CorpANDACurrent
0143-9986CEFACLORCEFACLORHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9986CEFACLORCEFACLORWest-Ward Pharmaceuticals CorpANDACurrent
43063-194CEFACLORCEFACLORPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-0518CEFACLORCEFACLORA-S Medication SolutionsANDACurrent
59115-071CEFACLORCEFACLORHikma PharmaceuticalANDACurrent
59115-072CEFACLORCEFACLORHikma PharmaceuticalANDACurrent
68289-003CefaclorcefaclorJazeera PharmaceuticalANDACurrent
68289-004CefaclorcefaclorJazeera PharmaceuticalANDACurrent