Potassium Chloride

Prevents hypokalemia. ANDA 77419, held by Actavis Labs Fl Inc. Potassium Chloride.

As of Nov 15, 2026, ANDA 77419 (Potassium Chloride), held by Actavis Labs Fl Inc, was first approved by FDA on Jun 2, 2008, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 2, 2008
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE: Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Jun 2, 2008	Original application	Approved	Label Review

Products

2 strengths and forms


Potassium Chloride8MEQ · capsule, extended release;oral	Potassium Chloride	Rx
Potassium Chloride10MEQ · capsule, extended release;oral	Potassium Chloride	Rx

All 4 submissions, including labeling and manufacturing supplements


Jun 10, 2020	Supplement 18Labeling · Standard review	Approved	None posted
Feb 26, 2013	Supplement 15Labeling · Standard review	Approved	None posted
Nov 22, 2010	Supplement 13Labeling	Approved	None posted
Jun 2, 2008	Original application	Approved	Label Review

Identifiers

Application: ANDA 77419
Drugs@FDA: Overview at FDA
Company: Actavis Laboratories FL

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