FDA.reportPublic FDA data

Application 065215

Type
ANDA
Sponsor
HIKMA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9897CephalexinCephalexinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9897CephalexinCephalexinWest-Ward Pharmaceuticals CorpANDACurrent
0143-9898CephalexinCephalexinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9898CephalexinCephalexinWest-Ward Pharmaceuticals CorpANDACurrent
0440-1243CephalexinCephalexinLiberty Pharmaceuticals, Inc.ANDACurrent
10544-066CephalexinCephalexinBlenheim Pharmacal, Inc.ANDACurrent
10544-617CephalexinCephalexinBlenheim Pharmacal, Inc.ANDACurrent
52959-031CephalexinCephalexinH.J. Harkins Company, Inc.ANDACurrent
61786-277CephalexinCephalexinREMEDYREPACK INC.ANDACurrent
63874-111CephalexinCephalexinAltura Pharmaceuticals, Inc.ANDACurrent
63874-112CephalexinCephalexinAltura Pharmaceuticals, Inc.ANDACurrent
66116-398CephalexinCephalexinMedVantx, Inc.ANDACurrent