FDA.reportPublic FDA data

Application 018632

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STERILE WATER FOR INJECTION IN PLASTIC CONTAINERSTERILE WATER FOR INJECTIONLIQUID;N/A100%YesYes
002STERILE 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
0338-0013Sterile WaterWaterBaxter Healthcare CompanyNDACurrent
0338-0013Sterile WaterWaterBaxter Healthcare CompanyNDACurrent
0338-0013Sterile WaterWaterBaxter Healthcare CompanyNDACurrent
0338-0013Sterile WaterWaterBaxter Healthcare CompanyNDACurrent
0338-0013Sterile WaterWaterBaxter Healthcare CompanyNDACurrent
0338-0013Sterile WaterWaterBaxter Healthcare CompanyNDACurrent
0338-0013Sterile WaterWaterBaxter Healthcare CompanyNDACurrent
0338-0013Sterile WaterWaterBaxter Healthcare CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
33527SUPPL2016-06-01
15051SUPPL2016-05-31