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CardiovascularINTRAVENOUSStandard

SMOFLIPID 20%

FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL

Standard Dose
3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SMOFLIPID 20% is listed in Drugs@FDA under application 207648 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL Form and strength EMULSION;INTRAVENOUS - 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) Sponsor FRESENIUS KABI USA Submission history Latest submission status date: 2025-07-24 00:00:00.

Structured Monograph

Clinical summary

Approval overview SMOFLIPID 20% is listed in Drugs@FDA under application 207648 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL Form and strength EMULSION;INTRAVENOUS - 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) Sponsor FRESENIUS KABI USA Submission history Latest submission status date: 2025-07-24 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
SMOFLIPID 20% (FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL) | Drug Monograph | MedicHelpline