FDA.reportPublic FDA data

Application 090349

Type
ANDA
Sponsor
AUROBINDO PHARMA

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
55150-116Ampicillin and SulbactamAmpicillin Sodium and Sulbactam SodiumAuroMedics Pharma LLCANDACurrent
55150-116Ampicillin and SulbactamAmpicillin Sodium and Sulbactam SodiumEugia US LLCANDACurrent
55150-117Ampicillin and SulbactamAmpicillin Sodium and Sulbactam SodiumAuroMedics Pharma LLCANDACurrent
55150-117Ampicillin and SulbactamAmpicillin Sodium and Sulbactam SodiumEugia US LLCANDACurrent