Details for New Drug Application (NDA): 018893

NDA 018893 describes SODIUM ACETATE, which is a drug marketed by Fresenius Kabi Usa, Hikma, Hospira, and Milla Pharms, and is included in four NDAs. It is available from five suppliers. Additional details are available on the SODIUM ACETATE profile page.

The generic ingredient in SODIUM ACETATE is sodium acetate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the sodium acetate profile page.

Summary for 018893

Tradename:	SODIUM ACETATE
Applicant:	Hospira
Ingredient:	sodium acetate
Patents:	0

Pharmacology for NDA: 018893

Mechanism of Action	Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

Suppliers and Packaging for NDA: 018893

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM ACETATE	sodium acetate	SOLUTION;INTRAVENOUS	018893	NDA	Hospira, Inc.	0409-3299	0409-3299-25	25 VIAL in 1 CASE (0409-3299-25) / 100 mL in 1 VIAL (0409-3299-45)
SODIUM ACETATE	sodium acetate	SOLUTION;INTRAVENOUS	018893	NDA	Hospira, Inc.	0409-3299	0409-3299-26	25 VIAL in 1 TRAY (0409-3299-26) / 50 mL in 1 VIAL (0409-3299-46)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	40MEQ/20ML (2MEQ/ML)
Approval Date:	May 4, 1983	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	100MEQ/50ML (2MEQ/ML)
Approval Date:	Sep 2, 2014	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	200MEQ/100ML (2MEQ/ML)
Approval Date:	Sep 2, 2014	TE:	AP	RLD:	Yes

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