Potassium Acetate

For restricted or no oral intake. Sold as Potassium Acetate. Every FDA application for this active ingredient: 1 branded and 3 generic.

As of Nov 14, 2026, FDA lists 4 applications for Potassium Acetate (sold as Potassium Acetate), first approved Jul 20, 1984, with 0 new uses approved and 0 published complete response letters.

First approved: Jul 20, 1984
Applications: 4
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $5K

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Potassium Acetate	Part D	$5K	+101%	28

Clinical Trials

4 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Hypernatremia Fluid Therapy in Childhood DiarrhoeaHypernatremia, Acute Watery Diarrhea · International Centre for Diarrhoeal Disease Research, Bangladesh	Not applicable	Enrolling by invitation	Oct 21, 2026
Analysis of the Influence of Dialysis Fluid Composition on Vascular Calcification in Patients With Chronic Kidney Disease Undergoing HemodialysisVascular Calcification, Hemodialysis · Hospital Clinic of Barcelona	Not applicable	Not yet recruiting	Sep 9, 2025
Multiple Electrolytes Injection (II) and Normal Saline on Hyperchloremia in Severe Hemorrhagic StrokeCritical Care, Hyperchloremia · Capital Medical University	Phase 4	Not yet recruiting	Apr 19, 2024
Healthy Mums, Healthy Babies: Multiple Micronutrient Supplementation in EthiopiaBirth Weight · London School of Hygiene and Tropical Medicine	—	Recruiting	Feb 1, 2023

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jul 20, 1984	Potassium AcetateNDA 18896 · New formulation or manufacturer	Hospira	12	Marketed
Dec 29, 2015	Potassium AcetateANDA 206203	Exela Pharma	1	Discontinued
Oct 20, 2021	Potassium AcetateANDA 212692	Exela Pharma	0	Marketed
Nov 27, 2024	Potassium AcetateANDA 217515	Fresenius Kabi USA	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA