FDA.reportPublic FDA data

Application 021321

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EXTRANEALICODEXTRINSOLUTION;INTRAPERITONEAL7.5GM/100MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0941-0679EXTRANEALicodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chlorideBaxter Healthcare CorporationNDACurrent
0941-0679EXTRANEALicodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chlorideBaxter Healthcare CorporationNDACurrent
0941-0679EXTRANEALicodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chlorideBaxter Healthcare CorporationNDACurrent
0941-0679EXTRANEALicodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chlorideBaxter Healthcare CorporationNDACurrent
0941-0679EXTRANEALicodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chlorideBaxter Healthcare CorporationNDACurrent
0941-0679EXTRANEALicodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chlorideBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78250SUPPL 2024-04-25
78207SUPPL 2024-04-23
61180SUPPL2019-12-06
61169SUPPL2019-12-06
46470SUPPL2016-12-22
46230SUPPL2016-12-20
45638SUPPL2016-10-25
15189SUPPL2015-10-22
5035SUPPL2015-10-21
5033SUPPL2014-12-11
5034SUPPL2014-02-27
23994ORIG2011-03-25
36653SUPPL2011-03-11
15188SUPPL2011-03-11
27477SUPPL2011-03-10
5032SUPPL2011-03-10
23254ORIG2009-11-18
36652SUPPL2009-04-16
5030SUPPL2009-04-15
5031SUPPL2009-02-03
5029SUPPL2007-03-06
5027SUPPL2005-05-25
5026SUPPL2005-05-25
36651SUPPL2004-12-30
5028SUPPL2004-12-30
27476ORIG2004-06-03
42099ORIG2003-04-25
15187ORIG2003-04-09