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General MedicationsINTRAVENOUSStandard

KABIVEN IN PLASTIC CONTAINER

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL

Standard Dose
3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview KABIVEN IN PLASTIC CONTAINER is listed in Drugs@FDA under application 200656 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL Form and strength EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML) Sponsor FRESENIUS KABI USA Submission history Latest submission status date: 2025-07-24 00:00:00.

Structured Monograph

Clinical summary

Approval overview KABIVEN IN PLASTIC CONTAINER is listed in Drugs@FDA under application 200656 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL Form and strength EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML) 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.