Details for New Drug Application (NDA): 200656

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NDA 200656 describes PERIKABIVEN IN PLASTIC CONTAINER, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from one supplier. Additional details are available on the PERIKABIVEN IN PLASTIC CONTAINER profile page.

The generic ingredient in PERIKABIVEN IN PLASTIC CONTAINER is amino acids; calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium acetate; sodium glycerophosphate; soybean oil. There are three hundred and fifty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amino acids; calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium acetate; sodium glycerophosphate; soybean oil profile page.

Tradename:	PERIKABIVEN IN PLASTIC CONTAINER
Applicant:	Fresenius Kabi Usa
Ingredient:	amino acids; calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium acetate; sodium glycerophosphate; soybean oil
Patents:	0

Mechanism of Action	Magnesium Ion Exchange Activity Osmotic Activity Phosphate Chelating Activity
Physiological Effect	Increased Coagulation Factor Activity Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption Inhibition Small Intestine Fluid/Electrolyte Absorption Stimulation Large Intestine Fluid/Electrolyte Secretion

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KABIVEN IN PLASTIC CONTAINER	amino acids; calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium acetate; sodium glycerophosphate; soybean oil	EMULSION;INTRAVENOUS	200656	NDA	Fresenius Kabi USA, LLC	63323-712	63323-712-10	1026 mL in 1 BAG (63323-712-10)
PERIKABIVEN IN PLASTIC CONTAINER	amino acids; calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium acetate; sodium glycerophosphate; soybean oil	EMULSION;INTRAVENOUS	200656	NDA	Fresenius Kabi USA, LLC	63323-712	63323-712-10	1026 mL in 1 BAG (63323-712-10)

Active Rx/OTC/Discontinued:	RX	Dosage:	EMULSION;INTRAVENOUS			Strength	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)
Approval Date:	Aug 25, 2014	TE:		RLD:	Yes

Active Rx/OTC/Discontinued:	RX	Dosage:	EMULSION;INTRAVENOUS			Strength	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML)
Approval Date:	Aug 25, 2014	TE:		RLD:	Yes

Active Rx/OTC/Discontinued:	RX	Dosage:	EMULSION;INTRAVENOUS			Strength	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)
Approval Date:	Aug 25, 2014	TE:		RLD:	Yes

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