Application 018897

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM CHLORIDE IN PLASTIC CONTAINERSODIUM CHLORIDEINJECTABLE;INJECTION2.5MEQ/MLYesNo
002SODIUM CHLORIDE 14.6%SODIUM CHLORIDESOLUTION;INTRAVENOUS100MEQ/40ML (2.5MEQ/ML)YesNo
003SODIUM CHLORIDE 23.4%SODIUM CHLORIDESOLUTION;INTRAVENOUS400MEQ/100ML (4MEQ/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-1141SODIUM CHLORIDESODIUM CHLORIDEHospira, Inc.NDACurrent
0409-1141SODIUM CHLORIDESODIUM CHLORIDEHospira, Inc.NDACurrent
0409-1141SODIUM CHLORIDESODIUM CHLORIDEHospira, Inc.NDACurrent
0409-6660Sodium ChlorideSODIUM CHLORIDEHospira, Inc.NDACurrent
0409-6660Sodium ChlorideSODIUM CHLORIDEHospira, Inc.NDACurrent
0409-6660Sodium ChlorideSODIUM CHLORIDEHospira, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63789SUPPL2020-07-02
16086SUPPL2002-03-14