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INTRALIPID 10%

NDA

SOYBEAN OIL | N017643 | FRESENIUS KABI DEUTSCHLAND GMBH

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from the Center for Science in the Public Interest (CSPI) FDA-2004-P-0279 · 7 docket documents The Center for Science in the Public Interest filed this citizen petition in May 2004 requesting that the FDA revoke the generally recognized as safe status of partially hydrogenated vegetable oils including shortening, soybean oil, menhaden oil, and canola oil, and prohibit their use in foods, citi	Other	2008-06-12	Partially Denied	the Center for Science in the Public Interest (CSPI)

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

48 trials from ClinicalTrials.gov, 2 active, 34 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Therapeutic Omegas for Triglyceride Suppression NCT04349475	N/A	Active	University of Colorado, Denver	40	2021-11-29 → 2026-05-31
Improving Maternal and Child Health Through Prenatal Fatty Acid Supplementation NCT02647723	N/A	Active	University of Chicago	168	2016-01 → 2027-12-31
Causal Relationships Between LC-omega-3-enriched Diet and Cognition NCT01625195	N/A	Completed	Université de Sherbrooke	273	2012-05-01 → 2017-12-02
Effect of Palm Olein Intake on Lipid Profile and Appetite Regulation NCT02924896	N/A	Completed	Imperial College London	12	2016-09 → 2017-04
Compare Effects of Flax Seed Oil, and Fish Oil on Blood Sugar Levels NCT00579540	N/A	Completed	University of California, Davis	66	2007-09 → 2009-09
Chronic Effects of Natural and Interesterified Fats Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD)NCT02192047	N/A	Completed	Malaysia Palm Oil Board	85	2012-09 → 2014-03
Effect of a Soluble Fibre Blend and Medium Chain Triglycerides on Body Composition and Cardiometabolic Risk Factors NCT00644098	Phase 2	Completed	Canadian Center for Functional Medicine	138	2008-09 → 2009-08
The Influence of Fish-oil Lipid Emulsions on Neonatal Morbidities NCT01875510	N/A	Completed	Dr. Sami Ulus Children's Hospital	80	2013-01 → 2013-11
The Effects of Various Cooking Oils on Health Related Biomarkers in Healthy Subjects NCT02599103	N/A	Completed	Academia Sinica, Taiwan	17	2013-09 → 2015-09
Evaluating the Effects of Omega-3 Fatty Acids on Heart Disease and Behavior NCT00663871	N/A	Completed	University of Pittsburgh	272	2008-06 → 2012-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain0 active DMFs1 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

AVATAR CORPInactiveSOYBEAN OIL, USP

DMF 69711987

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jul 25, 2025	SUPPL -85	View Letter (PDF)
May 18, 2023	SUPPL -83	View Letter (PDF)
May 4, 2022	SUPPL -82	View Letter (PDF)
Jul 26, 2018	SUPPL -78	View Letter (PDF)
Dec 6, 2016	SUPPL -76	View Letter (PDF)
May 1, 2007	SUPPL -72	View Letter (PDF)
Apr 20, 2004	SUPPL -70	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10%

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.