Application 065124

Type
ANDA
Sponsor
LUPIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFOTAXIME SODIUMCEFOTAXIME SODIUMINJECTABLE;INJECTIONEQ 500MG BASE/VIALNoNo
002CEFOTAXIME SODIUMCEFOTAXIME SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo
003CEFOTAXIME SODIUMCEFOTAXIME SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68180-811CEFOTAXIMECEFOTAXIMELupin Pharmaceuticals, Inc.ANDACurrent
68180-822CEFOTAXIMECEFOTAXIMELupin Pharmaceuticals, Inc.ANDACurrent
68180-833CEFOTAXIMECEFOTAXIMELupin Pharmaceuticals, Inc.ANDACurrent