FDA.reportPublic FDA data

Application 018315

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYCINE 1.5% IN PLASTIC CONTAINERGLYCINESOLUTION;IRRIGATION1.5GM/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-7974GlycineGLYCINEHospira, Inc.NDACurrent
0409-7974GlycineGLYCINEHospira, Inc.NDACurrent
0990-7974GlycineGLYCINEICU Medical Inc.NDACurrent
0990-7974GlycineGLYCINEICU Medical Inc.NDACurrent
0990-7974GlycineGLYCINEICU Medical Inc.NDACurrent
0990-7974GlycineGLYCINEICU Medical Inc.NDACurrent