FDA.reportPublic FDA data

Application 065135

Type
ANDA
Sponsor
LUPIN

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43063-584cefuroxime axetilcefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-584cefuroxime axetilcefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-584cefuroxime axetilcefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-584cefuroxime axetilcefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-584cefuroxime axetilcefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
49999-785cefuroxime axetilcefuroxime axetilLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0798cefuroxime axetilcefuroxime axetilA-S Medication SolutionsANDACurrent
57297-302cefuroxime axetilcefuroxime axetilLUPIN LIMITEDANDACurrent
57297-303cefuroxime axetilcefuroxime axetilLUPIN LIMITEDANDACurrent
60429-656cefuroxime axetilcefuroxime axetilGolden State Medical Supply, Inc.ANDACurrent
60429-656cefuroxime axetilcefuroxime axetilGolden State Medical Supply, Inc.ANDACurrent
60429-656cefuroxime axetilcefuroxime axetilGolden State Medical Supply Inc.ANDACurrent
60429-657cefuroxime axetilcefuroxime axetilGolden State Medical Supply Inc.ANDACurrent
60429-657cefuroxime axetilcefuroxime axetilGolden State Medical Supply, Inc.ANDACurrent
60429-657cefuroxime axetilcefuroxime axetilGolden State Medical Supply, Inc.ANDACurrent
68180-302cefuroxime axetilcefuroxime axetilLupin Pharmaceuticals, Inc.ANDACurrent
68180-302cefuroxime axetilcefuroxime axetilLupin Pharmaceuticals, Inc.ANDACurrent
68180-302cefuroxime axetilcefuroxime axetilLupin Pharmaceuticals, Inc.ANDACurrent
68180-303cefuroxime axetilcefuroxime axetilLupin Pharmaceuticals, Inc.ANDACurrent
68180-303cefuroxime axetilcefuroxime axetilLupin Pharmaceuticals, Inc.ANDACurrent
68180-303cefuroxime axetilcefuroxime axetilLupin Pharmaceuticals, Inc.ANDACurrent
68788-9700cefuroxime axetilcefuroxime axetilPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9701cefuroxime axetilcefuroxime axetilPreferred Pharmaceuticals, Inc.ANDACurrent