FDA.reportPublic FDA data

Application 018802

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINERSTERILE WATER FOR INJECTIONLIQUID;N/A100%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9970Bacteriostatic WaterWaterHenry Schein, Inc.NDACurrent
0404-9970Bacteriostatic WaterWaterHenry Schein, Inc.NDACurrent
0409-3977Bacteriostatic WaterBacteriostatic WaterHospira, Inc.NDACurrent
0409-3977Bacteriostatic WaterBacteriostatic WaterHospira, Inc.NDACurrent
0409-3977Bacteriostatic WaterBacteriostatic WaterHospira, Inc.NDACurrent
51662-1473BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1473BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirstNDACurrent
52584-977Bacteriostatic WaterWaterGeneral Injectables & Vaccine, IncNDACurrent
52584-977Bacteriostatic WaterWaterGeneral Injectables & Vaccine, IncNDACurrent
52584-977Bacteriostatic WaterWaterGeneral Injectables & Vaccine, IncNDACurrent
52584-977Bacteriostatic WaterWaterGeneral Injectables & Vaccine, IncNDACurrent
52584-977Bacteriostatic WaterWaterGeneral Injectables & Vaccine, IncNDACurrent
61699-3977Bacteriostatic WaterWATERUS MedSource, LLCNDACurrent
70518-1236Bacteriostatic WaterBacteriostatic WaterREMEDYREPACK INC.NDACurrent
70518-1236Bacteriostatic WaterBacteriostatic WaterREMEDYREPACK INC.NDACurrent
71872-7129Bacteriostatic WaterWATERMedical Purchasing Solutions, LLCNDACurrent
71872-7129Bacteriostatic WaterWATERMedical Purchasing Solutions, LLCNDACurrent