FDA.reportPublic FDA data

Application 018251

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RINGER'S IN PLASTIC CONTAINERCALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION33MG/100ML;30MG/100ML;860MG/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-7982RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEHospira, Inc.NDACurrent
0409-7982RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEHospira, Inc.NDACurrent
0990-7982RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7982RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7982RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7982RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7982RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85549SUPPL 2026-03-27
85530SUPPL 2026-03-26