Sodium Acetate

For restricted or no oral intake. NDA 18893, held by Hospira. Sodium Acetate.

As of Nov 13, 2026, NDA 18893 (Sodium Acetate), held by Hospira, was first approved by FDA on May 4, 1983, with 17 approved supplements and 0 published complete response letters.

First approved: May 4, 1983
Review: Standard
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Sodium Acetate Injection, USP (2 mEq/mL) is indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
May 4, 1983	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

3 strengths and forms


Sodium Acetate40MEQ/20ML (2MEQ/ML) · solution;intravenous	Sodium Acetate	RxReference drug
Sodium Acetate100MEQ/50ML (2MEQ/ML) · solution;intravenous	Sodium Acetate	RxReference drug
Sodium Acetate200MEQ/100ML (2MEQ/ML) · solution;intravenous	Sodium Acetate	RxReference drug

All 18 submissions, including labeling and manufacturing supplements


Sep 2, 2014	Supplement 25Manufacturing · Standard review	Approved	Label
Jun 12, 2014	Supplement 28Manufacturing · Standard review	Approved	None posted
Mar 3, 2003	Supplement 17Manufacturing · Standard review	Approved	Letter
Feb 16, 2001	Supplement 16Manufacturing · Standard review	Approved	None posted
Jun 15, 2000	Supplement 13Labeling · Standard review	Approved	None posted
Aug 31, 1999	Supplement 15Manufacturing · Standard review	Approved	None posted
Jan 22, 1999	Supplement 14Manufacturing · Standard review	Approved	None posted
May 5, 1998	Supplement 12Labeling · Standard review	Approved	None posted
Jan 17, 1997	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 29, 1996	Supplement 11Manufacturing · Standard review	Approved	None posted
Nov 17, 1988	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 11, 1987	Supplement 7Manufacturing · Standard review	Approved	None posted
Jul 24, 1986	Supplement 6Manufacturing · Standard review	Approved	None posted
May 14, 1985	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 15, 1985	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 22, 1984	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 17, 1984	Supplement 2Manufacturing · Standard review	Approved	None posted
May 4, 1983	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18893
Drugs@FDA: Overview at FDA
Company: Hospira

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters