FDA.reportPublic FDA data

Application 019022

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM CHLORIDE 3% IN PLASTIC CONTAINERSODIUM CHLORIDEINJECTABLE;INJECTION3GM/100MLYesYes
002SODIUM CHLORIDE 5% IN PLASTIC CONTAINERSODIUM CHLORIDEINJECTABLE;INJECTION5GM/100MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0054Sodium ChlorideSodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0054Sodium ChlorideSodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0054Sodium ChlorideSodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0054Sodium ChlorideSodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0054Sodium ChlorideSodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0056Sodium ChlorideSodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0056Sodium ChlorideSodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0056Sodium ChlorideSodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0056Sodium ChlorideSodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0056Sodium ChlorideSodium ChlorideBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55511SUPPL2018-09-18
55499SUPPL2018-09-18
33690SUPPL2015-01-08
1206SUPPL2014-12-30
16176SUPPL2005-08-31
11417SUPPL2005-08-31
11416SUPPL2005-06-14
1205SUPPL2005-06-14
1204SUPPL2002-04-03