FDA.reportPublic FDA data

Application 204508

Type
NDA
Sponsor
BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLINOLIPID 20%OLIVE OIL; SOYBEAN OILEMULSION;INTRAVENOUS16%(160GM/1000ML);4% (40GM/1000ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-9540ClinolipidOlive Oil and Soybean OilBaxter Healthcare CorporationNDACurrent
0338-9540ClinolipidOlive Oil and Soybean OilBaxter Healthcare CorporationNDACurrent
0338-9540ClinolipidOlive Oil and Soybean OilBaxter Healthcare CorporationNDACurrent
0338-9540ClinolipidOlive Oil and Soybean OilBaxter Healthcare CorporationNDACurrent
0338-9540ClinolipidOlive Oil and Soybean OilBaxter Healthcare CorporationNDACurrent
0338-9540ClinolipidOlive Oil and Soybean OilBaxter Healthcare CorporationNDACurrent
0338-9540ClinolipidOlive Oil and Soybean OilBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82957SUPPL 2025-07-28
82956SUPPL 2025-07-28
82940SUPPL 2025-07-25
78261SUPPL 2024-04-25
78242SUPPL 2024-04-25
74301SUPPL 2023-05-18
74300SUPPL 2023-05-18
74294SUPPL 2023-05-18
74293SUPPL 2023-05-18
67074SUPPL2021-04-16
67059SUPPL2021-04-14
10349SUPPL2016-07-22
40395SUPPL2016-07-21
44903ORIG2014-10-07
43466ORIG2014-10-07
19568ORIG2013-10-08
32565ORIG2013-10-04