Viewing data from:

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov, 2 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study in Healthy Adults to Compare the Bioavailability of EPA + DHA From Two Microalgal Sources to One Fish Source and Placebo NCT07241377	Phase 3	Active	RDC Clinical Pty Ltd	120	2025-10-27 → 2026-12
Specialized Pro-resolving Lipid Mediators and Treatment Resistant Depression NCT05774665	Phase 2	Active	Massachusetts General Hospital	14	2025-01-30 → 2027-03-31

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

Approval Letters

7 letters from Drugs@FDA

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.