NDA 200656, held by Fresenius Kabi USA. Amino Acids; Calcium Chloride; Dextrose; Magnesium Sulfate; Potassium Chloride; Sodium Acetate; Sodium Glycerophosphate; Soybean Oil.
As of Nov 13, 2026, NDA 200656 (Perikabiven In Plastic Container, Kabiven In Plastic Container), held by Fresenius Kabi USA, was first approved by FDA on Aug 25, 2014, with 6 approved supplements and 0 published complete response letters.
KABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. KABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients. Limitations of Use: KABIVEN is not recommended for use in pediatric patients under the age of 2 years, including preterm infants because the fixed content of the formulation does not meet the nutritional requirements of this age group.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 25, 2014 | Original applicationNew active ingredient · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Perikabiven In Plastic Container2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML) · emulsion;intravenous | Amino Acids; Calcium Chloride; Dextrose; Magnesium Sulfate; Potassium Chloride; Sodium Acetate; Sodium Glycerophosphate; Soybean Oil | RxReference drug |
| Perikabiven In Plastic Container2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML) · emulsion;intravenous | Amino Acids; Calcium Chloride; Dextrose; Magnesium Sulfate; Potassium Chloride; Sodium Acetate; Sodium Glycerophosphate; Soybean Oil | RxReference drug |
| Perikabiven In Plastic Container2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML) · emulsion;intravenous | Amino Acids; Calcium Chloride; Dextrose; Magnesium Sulfate; Potassium Chloride; Sodium Acetate; Sodium Glycerophosphate; Soybean Oil | RxReference drug |
| Kabiven In Plastic Container3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML) · emulsion;intravenous | Amino Acids; Calcium Chloride; Dextrose; Magnesium Sulfate; Potassium Chloride; Sodium Acetate; Sodium Glycerophosphate; Soybean Oil | RxReference drug |
| Kabiven In Plastic Container3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML) · emulsion;intravenous | Amino Acids; Calcium Chloride; Dextrose; Magnesium Sulfate; Potassium Chloride; Sodium Acetate; Sodium Glycerophosphate; Soybean Oil | RxReference drug |
| Kabiven In Plastic Container3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML) · emulsion;intravenous | Amino Acids; Calcium Chloride; Dextrose; Magnesium Sulfate; Potassium Chloride; Sodium Acetate; Sodium Glycerophosphate; Soybean Oil | RxReference drug |
| Kabiven In Plastic Container3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML) · emulsion;intravenous | Amino Acids; Calcium Chloride; Dextrose; Magnesium Sulfate; Potassium Chloride; Sodium Acetate; Sodium Glycerophosphate; Soybean Oil | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 24, 2025 | Supplement 24Labeling · Standard review | Approved | |
| May 17, 2023 | Supplement 18Labeling · Standard review | Approved | |
| Jun 28, 2022 | Supplement 14Labeling · Standard review | Approved | |
| Jun 9, 2016 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Apr 12, 2016 | Supplement 1Labeling · Standard review | Approved | |
| Apr 11, 2016 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Aug 25, 2014 | Original applicationNew active ingredient · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
