FDA.reportPublic FDA data

Application 017643

Type
NDA
Sponsor
FRESENIUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INTRALIPID 10%SOYBEAN OILINJECTABLE;INJECTION10%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0518IntralipidI.V. Fat EmulsionBaxter Healthcare CORPNDACurrent
0338-0518IntralipidI.V. Fat EmulsionBaxter Healthcare CORPNDACurrent
0338-0518IntralipidSOYBEAN OILBaxter Healthcare CORPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82948SUPPL 2025-07-28
82985SUPPL 2025-07-25
74305SUPPL 2023-05-18
74281SUPPL 2023-05-18
71015SUPPL2022-05-06
70987SUPPL2022-05-04
55032SUPPL2018-07-27
55003SUPPL2018-07-26
46059SUPPL2016-12-06
46015SUPPL2016-12-05
671SUPPL2007-05-01
33324SUPPL2007-04-25
670SUPPL2004-04-20