Application 065359

Type
ANDA
Sponsor
ORCHID HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFUROXIME AXETILCEFUROXIME AXETILTABLET;ORALEQ 125MG BASENoNo
002CEFUROXIME AXETILCEFUROXIME AXETILTABLET;ORALEQ 250MG BASENoNo
003CEFUROXIME AXETILCEFUROXIME AXETILTABLET;ORALEQ 500MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66116-479Cefuroxime AxetilCefuroxime AxetilMedVantx, Inc.ANDACurrent