FDA.reportPublic FDA data

Application 020248

Type
NDA
Sponsor
FRESENIUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INTRALIPID 20%SOYBEAN OILINJECTABLE;INJECTION20%YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020248-001INTRALIPID 20%SOYBEAN OIL20%INJECTABLE / INJECTIONAPRLD, RS1996-08-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N020248-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N020248-001INTRALIPID 20%20%INJECTABLE / INJECTIONAPRLD, RS1996-08-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N020248-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IntralipidI.V. FAT EMULSIONFresenius Kabi USA, LLCbdcc364b-77b2-4939-8add-03e5396d46c22025-10-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 020248
application number: NDA020248
IntralipidI.V. FAT EMULSIONBaxter Healthcare Corporation55609586-f0b4-42e6-8dd9-cd090afb5dca2022-07-21Boxed warning, Adverse reactionsExact identifier
application applno (NDA): 020248
application number: NDA020248
ndc (product): 0338-0519
IntralipidI.V. FAT EMULSIONBaxter Healthcare Corporationa69c82da-15ba-4d4d-8d7f-871dc3981eb82022-07-21Boxed warning, Adverse reactionsExact identifier
ndc (product): 0338-0519
IntralipidI.V. FAT EMULSIONBaxter Healthcare Corporationcbd3396e-6b85-41bf-82d2-940beba866862019-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020248
application number: NDA020248
ndc (product): 0338-0519

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0519IntralipidSOYBEAN OILBaxter Healthcare CORPNDACurrent
0338-0519IntralipidI.V. Fat EmulsionBaxter Healthcare CorporationNDACurrent
0338-0519IntralipidI.V. Fat EmulsionBaxter Healthcare CorporationNDACurrent
0338-0519IntralipidI.V. Fat EmulsionBaxter Healthcare CorporationNDACurrent
0338-0519IntralipidSOYBEAN OILBaxter Healthcare CorporaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82951SUPPL 2025-07-28
82984SUPPL 2025-07-25
74310SUPPL 2023-05-18
74309SUPPL 2023-05-18
74286SUPPL 2023-05-18
74285SUPPL 2023-05-18
71012SUPPL2022-05-06
70990SUPPL2022-05-04
55006SUPPL2018-07-26
46062SUPPL2016-12-06
46017SUPPL2016-12-05