FDA.reportPublic FDA data

Application 065314

Type
ANDA
Sponsor
ISTITUTO BIO ITA SPA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMPICILLIN AND SULBACTAMAMPICILLIN SODIUM; SULBACTAM SODIUMINJECTABLE;INJECTIONEQ 10GM BASE/VIAL;EQ 5GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-370Ampicillin and Sulbactamampicillin sodium and sulbactam sodiumFresenius Kabi USA, LLCANDACurrent
63323-370Ampicillin and Sulbactamampicillin sodium and sulbactam sodiumFresenius Kabi USA, LLCANDACurrent