FDA.reportPublic FDA data

Application 091613

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NAFCILLIN SODIUMNAFCILLIN SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo
002NAFCILLIN SODIUMNAFCILLIN SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-122NafcillinNafcillin SodiumAuroMedics Pharma LLCANDACurrent
55150-122NafcillinNafcillin SodiumAuroMedics Pharma LLCANDACurrent
55150-122NafcillinNafcillin SodiumAuroMedics Pharma LLCANDACurrent
55150-123NafcillinNafcillin SodiumAuroMedics Pharma LLCANDACurrent
55150-123NafcillinNafcillin SodiumAuroMedics Pharma LLCANDACurrent
55150-123NafcillinNafcillin SodiumAuroMedics Pharma LLCANDACurrent
55150-123NafcillinNafcillin SodiumAuroMedics Pharma LLCANDACurrent
55150-123NafcillinNafcillin SodiumAuroMedics Pharma LLCANDACurrent
55150-123NafcillinNafcillin SodiumAuroMedics Pharma LLCANDACurrent