Orange Book product · Brand (NDA)

KABIVEN IN PLASTIC CONTAINER

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

Brand (NDA)NDA 200656RX FRESENIUS KABI USA

Aug 25, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Aug 25, 2014
12 yr ago
Today
Patent 12390398 expires
Listed drug product patent expiration.
May 03, 2036
in 10 yr

Active ingredient

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

Strength

3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML)

Dosage form

EMULSION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 200656

Product number

006

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12390398	May 03, 2036	in 10 yr	Product