FDA.reportPublic FDA data

Application 065222

Type
ANDA
Sponsor
ISTITUTO BIO ITA SPA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMPICILLIN AND SULBACTAMAMPICILLIN SODIUM; SULBACTAM SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIAL;EQ 500MG BASE/VIALNoNo
002AMPICILLIN AND SULBACTAMAMPICILLIN SODIUM; SULBACTAM SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIAL;EQ 1GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-368Ampicillin and Sulbactamampicillin sodium and sulbactam sodiumFresenius Kabi USA, LLCANDACurrent
63323-368Ampicillin and Sulbactamampicillin sodium and sulbactam sodiumFresenius Kabi USA, LLCANDACurrent
63323-369Ampicillin and Sulbactamampicillin sodium and sulbactam sodiumFresenius Kabi USA, LLCANDACurrent
63323-369Ampicillin and Sulbactamampicillin sodium and sulbactam sodiumFresenius Kabi USA, LLCANDACurrent