FDA.reportPublic FDA data

Application 018233

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STERILE 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
0409-7990Sterile WaterwaterHospira, Inc.NDACurrent
0409-7990Sterile WaterwaterHospira, Inc.NDACurrent
0409-7990Sterile WaterwaterHospira, Inc.NDACurrent
0990-7990Sterile WaterwaterICU Medical Inc.NDACurrent
0990-7990Sterile WaterwaterICU Medical Inc.NDACurrent
0990-7990Sterile WaterwaterICU Medical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
880SUPPL2007-11-08
879SUPPL2005-01-26
14951SUPPL2003-01-24