Potassium Chloride

ANDA 80203, held by Baxter Hlthcare. Potassium Chloride.

As of Nov 15, 2026, ANDA 80203 (Potassium Chloride), held by Baxter Hlthcare, was first approved by FDA on May 25, 1971, with 3 approved supplements and 0 published complete response letters.

First approved: May 25, 1971
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
May 25, 1971	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Potassium Chloride2MEQ/ML · injectable;injection	Potassium Chloride	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Nov 3, 1986	Supplement 37Manufacturing	Approved	None posted
May 10, 1983	Supplement 33Manufacturing	Approved	None posted
Jan 31, 1983	Supplement 31Manufacturing	Approved	None posted
May 25, 1971	Original application	Approved	None posted

Identifiers

Application: ANDA 80203
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