KABIVEN IN PLASTIC CONTAINERamino acids, calcium chloride, dextrose, magnesium sulfate, potassium chloride, sodium acetate, sodium glycerophosphate, soybean oil

FDA approved the original new drug application for KABIVEN IN PLASTIC CONTAINER on August 25, 2014, sponsored by FRESENIUS KABI USA. FDA’s record shows no approved efficacy supplement on the application since.

Application

NDA200656

Sponsor

FRESENIUS KABI USA

Original approval

August 25, 2014

Review

standard review

Submission class

Type 2 - New Active Ingredient

Active ingredient

amino acids, calcium chloride, dextrose, magnesium sulfate, potassium chloride, sodium acetate, sodium glycerophosphate, soybean oil

Browse every approval whose brand starts with K, or the complete response letters FDA has published — the applications it did not approve.

Products under this application

Approved efficacy supplements

An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.

FDA’s record shows no approved efficacy supplement on this application.

FDA records other approved supplements on this application, by the class code it assigns them: Labeling 4 · Manufacturing (CMC) 2. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.

Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.

Other approvals to FRESENIUS KABI USA

• July 29, 2026GLYCOPHOSNDA220381
• June 9, 2025ROCURONIUM BROMIDENDA217472
• March 14, 2025TYENNEBLA761449
• March 13, 2025EPINEPHRINENDA215425
• September 27, 2024OTULFIBLA761379
• March 5, 2024TYENNEBLA761275