FDA.reportPublic FDA data

Application 065079

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PENICILLIN G POTASSIUMPENICILLIN G POTASSIUMINJECTABLE;INJECTION1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
002PENICILLIN G POTASSIUMPENICILLIN G POTASSIUMINJECTABLE;INJECTION5,000,000 UNITS/VIALNoNo
003PENICILLIN G POTASSIUMPENICILLIN G POTASSIUMINJECTABLE;INJECTION20,000,000 UNITS/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-6135Penicillin G PotassiumPenicillin G PotassiumSandoz IncANDACurrent
0781-6135Penicillin G PotassiumPenicillin G PotassiumSandoz IncANDACurrent
0781-6135Penicillin G PotassiumPenicillin G PotassiumSandoz IncANDACurrent
0781-6136Penicillin G PotassiumPenicillin G PotassiumSandoz IncANDACurrent
0781-6136Penicillin G PotassiumPenicillin G PotassiumSandoz IncANDACurrent
0781-6136Penicillin G PotassiumPenicillin G PotassiumSandoz IncANDACurrent
51662-1436BUFFERED PENICILLIN G POTASSIUMBUFFERED PENICILLIN G POTASSIUMHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1436BUFFERED PENICILLIN G POTASSIUMBUFFERED PENICILLIN G POTASSIUMHF Acquisition Co LLC, DBA HealthFirstANDACurrent