Potassium Chloride 10meq In Plastic Container, Potassium Chloride 20meq In Plastic Container, Potassium Chloride 30meq In Plastic Container

Treats potassium deficiency states. NDA 19904, held by Baxter Hlthcare. Potassium Chloride.

As of Nov 14, 2026, NDA 19904 (Potassium Chloride 10meq In Plastic Container, Potassium Chloride 20meq In Plastic Container, Potassium Chloride 30meq In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Dec 26, 1989, with 16 approved supplements and 0 published complete response letters.

First approved: Dec 26, 1989
Review: Standard
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Potassium Chloride Injection is indicated in the treatment of potassium deficiency states when oral replacement is not feasible. THIS HIGHLY CONCENTRATED, READY-TO-USE POTASSIUM CHLORIDE INJECTION IS INTENDED FOR THE MAINTENANCE OF SERUM K + LEVELS AND FOR POTASSIUM SUPPLEMENTATION IN FLUID RESTRICTED PATIENTS WHO CANNOT ACCOMMODATE ADDITIONAL VOLUMES OF FLUID ASSOCIATED WITH POTASSIUM SOLUTIONS OF LOWER CONCENTRATION. When using these products, these patients should be on continuous cardiac monitoring and frequent testing for serum potassium concentration and acid-base balance.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Dec 26, 1989	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

6 strengths and forms


Potassium Chloride 10meq In Plastic Container14.9MG/ML · injectable;injection	Potassium Chloride	RxReference drug
Potassium Chloride 20meq In Plastic Container29.8MG/ML · injectable;injection	Potassium Chloride	RxReference drug
Potassium Chloride 30meq In Plastic Container2.24GM/100ML · injectable;injection	Potassium Chloride	DiscontinuedReference drug
Potassium Chloride 40meq In Plastic Container2.98GM/100ML · injectable;injection	Potassium Chloride	RxReference drug
Potassium Chloride 10meq In Plastic Container746MG/100ML · injectable;injection	Potassium Chloride	RxReference drug
Potassium Chloride 20meq In Plastic Container1.49GM/100ML · injectable;injection	Potassium Chloride	RxReference drug

All 17 submissions, including labeling and manufacturing supplements


Jun 13, 2024	Supplement 25Labeling · Standard review	Approved	Label Letter
Jun 13, 2022	Supplement 21Labeling · Standard review	Approved	Label Letter
Jun 20, 2019	Supplement 20Labeling · Standard review	Approved	Label Letter
Jan 7, 2017	Supplement 14Labeling · Standard review	Approved	Letter Label
Feb 3, 2015	Supplement 15Manufacturing · Standard review	Approved	None posted
Mar 14, 2012	Supplement 12Labeling · Standard review	Approved	Letter
Jan 12, 2001	Supplement 5Labeling	Approved	None posted
Dec 31, 1997	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 6, 1996	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 30, 1994	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 1, 1994	Supplement 8Labeling · Standard review	Approved	None posted
Feb 18, 1994	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 29, 1991	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 26, 1991	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 17, 1990	Supplement 3Labeling	Approved	None posted
Dec 17, 1990	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 26, 1989	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19904
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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