← FDA DRUG APPROVALS

FDA NDA · NDA207648

SMOFLIPID

Sponsor: FRESENIUS KABI USA

APPLICATION
NDA207648
TYPE
NDA
ORIGINAL APPROVAL
2016-07-13
LATEST ACTION
2025-07-24
ROUTE
INTRAVENOUS
DOSAGE FORM
EMULSION
MARKETING STATUS
Prescription

Products

SMOFLIPID 20% · ReferencePrescription
FISH OIL 3GM/100ML, MEDIUM CHAIN TRIGLYCERIDES 6GM/100ML, OLIVE OIL 5GM/100ML, SOYBEAN OIL 6GM/100ML (1000ML) · EMULSION · INTRAVENOUS
SMOFLIPID 20% · ReferencePrescription
FISH OIL 3GM/100ML, MEDIUM CHAIN TRIGLYCERIDES 6GM/100ML, OLIVE OIL 5GM/100ML, SOYBEAN OIL 6GM/100ML (250ML) · EMULSION · INTRAVENOUS
SMOFLIPID 20% · ReferencePrescription
FISH OIL 3GM/100ML, MEDIUM CHAIN TRIGLYCERIDES 6GM/100ML, OLIVE OIL 5GM/100ML, SOYBEAN OIL 6GM/100ML (500ML) · EMULSION · INTRAVENOUS
SMOFLIPID 20% · ReferencePrescription
FISH OIL 3GM/100ML, MEDIUM CHAIN TRIGLYCERIDES 6GM/100ML, OLIVE OIL 5GM/100ML, SOYBEAN OIL 6GM/100ML (100ML) · EMULSION · INTRAVENOUS

Approval history

2025-07-24Labeling · Supplement 13 · standard — Letter ↗AP
2023-05-17Labeling · Supplement 10 · standard — Label ↗AP
2022-03-22Efficacy · Supplement 5 · priority — Label ↗AP
2020-05-08Labeling · Supplement 3 · standard — Letter ↗AP
2016-07-13Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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