Potassium Acetate

For restricted or no oral intake. NDA 18896, held by Hospira. Potassium Acetate.

As of Nov 13, 2026, NDA 18896 (Potassium Acetate), held by Hospira, was first approved by FDA on Jul 20, 1984, with 12 approved supplements and 0 published complete response letters.

First approved: Jul 20, 1984
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Potassium Acetate Injection, USP, 40 mEq is indicated as a source of potassium, for the addition to large volume intravenous fluids, to prevent or correct hypokalemia 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 13 submissions below

Date	Submission	Status	Documents
Jul 20, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Potassium Acetate2MEQ/ML · injectable;injection	Potassium Acetate	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Jun 12, 2014	Supplement 22Manufacturing · Standard review	Approved	None posted
Dec 24, 2002	Supplement 12Manufacturing · Standard review	Approved	Review Letter
Feb 16, 2001	Supplement 11Manufacturing · Standard review	Approved	Review
Feb 11, 2000	Supplement 8Labeling · Standard review	Approved	None posted
Aug 31, 1999	Supplement 10Manufacturing · Standard review	Approved	None posted
Jan 22, 1999	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 13, 1998	Supplement 7Labeling · Standard review	Approved	None posted
Jan 17, 1997	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 29, 1996	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 21, 1988	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 11, 1987	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 24, 1986	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 20, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18896
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