← FDA Drug Approvals (Drugs@FDA)

KABIVEN IN PLASTIC CONTAINER

NDA · New Drug Application · Sponsor: FRESENIUS KABI USA · Approved 2014-08-25

Drug application

FDA Application #
NDA200656
Application type
New Drug Application
Brand name
KABIVEN IN PLASTIC CONTAINER
Generic name
DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE
Active ingredients
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL
Dosage form
EMULSION
Route
INTRAVENOUS
Marketing status
Prescription
Sponsor
FRESENIUS KABI USA
Manufacturer
Fresenius Kabi USA, LLC
First approval
2014-08-25

Source

Authoritative
Drugs@FDA application overview
Machine
JSON-LD · Markdown