FDA.reportPublic FDA data

Application 018800

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDEINJECTABLE;INJECTION9MG/MLYesYes
002BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDESOLUTION;INJECTION180MG/20ML (9MG/ML)YesYes
003BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDESOLUTION;INJECTION270MG/30ML (9MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9953Bacteriostatic Sodium ChlorideSodium ChlorideHenry Schein, Inc.NDACurrent
0404-9953Bacteriostatic Sodium ChlorideSodium ChlorideHenry Schein, Inc.NDACurrent
0404-9953Bacteriostatic Sodium ChlorideSodium ChlorideHenry Schein, Inc.NDACurrent
0404-9953Bacteriostatic Sodium ChlorideSodium ChlorideHenry Schein, Inc.NDACurrent
0409-1966BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEHospira, Inc.NDACurrent
0409-1966BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEHospira, Inc.NDACurrent
0409-1966BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEHospira, Inc.NDACurrent
51662-1257BACTERIOSTATIC SODIUM CHLORIDEBACTERIOSTATIC SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1257BACTERIOSTATIC SODIUM CHLORIDEBACTERIOSTATIC SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1257BACTERIOSTATIC SODIUM CHLORIDEBACTERIOSTATIC SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1257BACTERIOSTATIC SODIUM CHLORIDEBACTERIOSTATIC SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1259BACTERIOSTATIC SODIUM CHLORIDEBACTERIOSTATIC SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1259BACTERIOSTATIC SODIUM CHLORIDEBACTERIOSTATIC SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1259BACTERIOSTATIC SODIUM CHLORIDEBACTERIOSTATIC SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1259BACTERIOSTATIC SODIUM CHLORIDEBACTERIOSTATIC SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
52584-966Bacteriostatic Sodium ChlorideSodium ChlorideGeneral Injectables & Vaccines, Inc.NDACurrent
52584-966Bacteriostatic Sodium ChlorideSodium ChlorideGeneral Injectables & Vaccines, Inc.NDACurrent
52584-966Bacteriostatic Sodium ChlorideSodium ChlorideGeneral Injectables & Vaccines, Inc.NDACurrent
52584-966Bacteriostatic Sodium ChlorideSodium ChlorideGeneral Injectables & Vaccines, Inc.NDACurrent
52584-966Bacteriostatic Sodium ChlorideSodium ChlorideGeneral Injectables & Vaccines, Inc.NDACurrent
52584-966Bacteriostatic Sodium ChlorideSodium ChlorideGeneral Injectables & Vaccines, Inc.NDACurrent
52584-966Bacteriostatic Sodium ChlorideSodium ChlorideGeneral Injectables & Vaccines, Inc.NDACurrent
55154-3183Sodium ChlorideSodium ChlorideCardinal HealthNDACurrent
61699-1966Sodium ChlorideSODIUM CHLORIDEUS MedSource, LLCNDACurrent
70518-1318BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEREMEDYREPACK INC.NDACurrent
71872-7083BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEMedical Purchasing Solutions, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
16055SUPPL2003-02-19