Application 065448

Type
ANDA
Sponsor
ISTITUTO BIO ITA SPA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PENICILLIN G POTASSIUMPENICILLIN G POTASSIUMINJECTABLE;INJECTION5,000,000 UNITS/VIALNoNo
002PENICILLIN G POTASSIUMPENICILLIN G POTASSIUMINJECTABLE;INJECTION20,000,000 UNITS/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70860-126Penicillin G Potassiumpenicillin g potassiumAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-127Penicillin G Potassiumpenicillin g potassiumAthenex Pharmaceutical Division, LLC.ANDACurrent