FDA.reportPublic FDA data

Application 065166

Type
ANDA
Sponsor
WOCKHARDT

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
55289-385Cefuroxime AxetilCefuroxime AxetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-385Cefuroxime AxetilCefuroxime AxetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-385Cefuroxime AxetilCefuroxime AxetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-385Cefuroxime AxetilCefuroxime AxetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
55648-920Cefuroxime AxetilCefuroxime AxetilWockhardt LimitedANDACurrent
55648-921Cefuroxime AxetilCefuroxime AxetilWockhardt LimitedANDACurrent
55648-922Cefuroxime AxetilCefuroxime AxetilWockhardt LimitedANDACurrent
64679-920Cefuroxime AxetilCefuroxime AxetilWockhardt USA LLC.ANDACurrent
64679-920Cefuroxime AxetilCefuroxime AxetilWockhardt USA LLC.ANDACurrent
64679-921Cefuroxime AxetilCefuroxime AxetilWockhardt USA LLC.ANDACurrent
64679-921Cefuroxime AxetilCefuroxime AxetilWockhardt USA LLC.ANDACurrent
64679-922Cefuroxime AxetilCefuroxime AxetilWockhardt USA LLC.ANDACurrent
64679-922Cefuroxime AxetilCefuroxime AxetilWockhardt USA LLC.ANDACurrent
68788-9333Cefuroxime AxetilCefuroxime AxetilPreferred Pharmaceuticals, Inc.ANDACurrent