FDA.reportPublic FDA data

Application 090005

Type
ANDA
Sponsor
ISTITUTO BIO ITA SPA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NAFCILLIN SODIUMNAFCILLIN SODIUMINJECTABLE;INJECTIONEQ 10GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44567-223NafcillinNAFCILLINWG Critical Care, LLCANDACurrent
63323-330NafcillinNAFCILLINFresenius Kabi USA, LLCANDACurrent
63323-330NafcillinNAFCILLINFresenius Kabi USA, LLCANDACurrent
63323-330NafcillinNAFCILLINFresenius Kabi USA, LLCANDACurrent
63323-330NafcillinNAFCILLINFresenius Kabi USA, LLCANDACurrent
70860-119Nafcillinnafcillin sodiumAthenex Pharmaceutical Division, LLC.ANDACurrent