← FDA DRUG APPROVALS

FDA NDA · NDA200656

KABIVEN

dextrose, soybean oil, electrolytes, lysine, phenylalanine, leucine, valine, threonine, methionine, isoleucine, tryptophan, alanine, arginine, glycine, proline, histidine, glutamic acid, serine, aspartic acid and tyrosine

Sponsor: FRESENIUS KABI USA

APPLICATION
NDA200656
TYPE
NDA
ORIGINAL APPROVAL
2014-08-25
LATEST ACTION
2025-07-24
ROUTE
INTRAVENOUS
DOSAGE FORM
EMULSION
MARKETING STATUS
Prescription

Products

KABIVEN IN PLASTIC CONTAINER · ReferencePrescription
AMINO ACIDS 3.3%, CALCIUM CHLORIDE 29MG/100ML, DEXTROSE 9.8GM/100ML, MAGNESIUM SULFATE 96MG/100ML, POTASSIUM CHLORIDE 174MG/100ML, SODIUM ACETATE 239MG/100ML, SODIUM GLYCEROPHOSPHATE 147MG/100ML, SOYBEAN OIL 3.9GM/100ML (2053ML) · EMULSION · INTRAVENOUS
KABIVEN IN PLASTIC CONTAINER · ReferencePrescription
AMINO ACIDS 3.3%, CALCIUM CHLORIDE 29MG/100ML, DEXTROSE 9.8GM/100ML, MAGNESIUM SULFATE 96MG/100ML, POTASSIUM CHLORIDE 174MG/100ML, SODIUM ACETATE 239MG/100ML , SODIUM GLYCEROPHOSPHATE 147MG/100ML, SOYBEAN OIL 3.9GM/100ML (1026ML) · EMULSION · INTRAVENOUS
PERIKABIVEN IN PLASTIC CONTAINER · ReferencePrescription
AMINO ACIDS 2.4%, CALCIUM CHLORIDE 20MG/100ML, DEXTROSE 6.8GM/100ML, MAGNESIUM SULFATE 68MG/100ML, POTASSIUM CHLORIDE 124MG/100ML, SODIUM ACETATE 170MG/100ML, SODIUM GLYCEROPHOSPHATE 105MG/100ML, SOYBEAN OIL 3.5GM/100ML (1920ML) · EMULSION · INTRAVENOUS
KABIVEN IN PLASTIC CONTAINER · ReferencePrescription
AMINO ACIDS 3.3%, CALCIUM CHLORIDE 29MG/100ML, DEXTROSE 9.8GM/100ML, MAGNESIUM SULFATE 96MG/100ML, POTASSIUM CHLORIDE 174MG/100ML, SODIUM ACETATE 239MG/100ML, SODIUM GLYCEROPHOSPHATE 147MG/100ML, SOYBEAN OIL 3.9GM/100ML (2566ML) · EMULSION · INTRAVENOUS
KABIVEN IN PLASTIC CONTAINER · ReferencePrescription
AMINO ACIDS 3.3%, CALCIUM CHLORIDE 29MG/100ML, DEXTROSE 9.8GM/100ML, MAGNESIUM SULFATE 96MG/100ML, POTASSIUM CHLORIDE 174MG/100ML, SODIUM ACETATE 239MG/100ML, SODIUM GLYCEROPHOSPHATE 147MG/100ML, SOYBEAN OIL 3.9GM/100ML (1540ML) · EMULSION · INTRAVENOUS
PERIKABIVEN IN PLASTIC CONTAINER · ReferencePrescription
AMINO ACIDS 2.4%, CALCIUM CHLORIDE 20MG/100ML, DEXTROSE 6.8GM/100ML, MAGNESIUM SULFATE 68MG/100ML, POTASSIUM CHLORIDE 124MG/100ML, SODIUM ACETATE 170MG/100ML , SODIUM GLYCEROPHOSPHATE 105MG/100ML, SOYBEAN OIL 3.5GM/100ML (2400ML) · EMULSION · INTRAVENOUS
PERIKABIVEN IN PLASTIC CONTAINER · ReferencePrescription
AMINO ACIDS 2.4%, CALCIUM CHLORIDE 20MG/100ML, DEXTROSE 6.8GM/100ML, MAGNESIUM SULFATE 68MG/100ML, POTASSIUM CHLORIDE 124MG/100ML, SODIUM ACETATE 170MG/100ML, SODIUM GLYCEROPHOSPHATE 105MG/100ML, SOYBEAN OIL 3.5GM/100ML (1440ML) · EMULSION · INTRAVENOUS

Approval history

2025-07-24Labeling · Supplement 24 · standard — Letter ↗AP
2023-05-17Labeling · Supplement 18 · standard — Label ↗AP
2022-06-28Labeling · Supplement 14 · standard — Letter ↗AP
2016-06-09Manufacturing (CMC) · Supplement 3 · standardAP
2016-04-12Labeling · Supplement 1 · standard — Letter ↗AP
2016-04-11Manufacturing (CMC) · Supplement 2 · standardAP
2014-08-25Type 2 - New Active Ingredient · Original · standard — Review ↗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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