Klor-Con M20, Klor-Con M10, Klor-Con M15

Treats hypokalemia with or without metabolic alkalosis, in digitalis intoxication. ANDA 74726, held by Upsher Smith Labs. Potassium Chloride.

As of Nov 15, 2026, ANDA 74726 (Klor-Con M20, Klor-Con M10, Klor-Con M15), held by Upsher Smith Labs, was first approved by FDA on Nov 20, 1998, with 17 approved supplements and 0 published complete response letters.

First approved: Nov 20, 1998
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication and in patients with hypokalemic familial periodic paralysis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Nov 20, 1998	Original application	Approved	Label Review Letter

Products

3 strengths and forms


Klor-Con M2020MEQ · tablet, extended release;oral	Potassium Chloride	Rx
Klor-Con M1010MEQ · tablet, extended release;oral	Potassium Chloride	Rx
Klor-Con M1515MEQ · tablet, extended release;oral	Potassium Chloride	Rx

All 18 submissions, including labeling and manufacturing supplements


Mar 3, 2011	Supplement 34Labeling	Approved	None posted
Nov 24, 2008	Supplement 32Labeling	Approved	None posted
Jun 6, 2003	Supplement 17Labeling	Approved	None posted
Jun 6, 2003	Supplement 16Manufacturing	Approved	Review
Jun 6, 2003	Supplement 11Labeling	Approved	None posted
Dec 19, 2002	Supplement 18Manufacturing	Approved	None posted
Mar 29, 2002	Supplement 14Manufacturing	Approved	None posted
Mar 29, 2002	Supplement 13Manufacturing	Approved	Review
Feb 8, 2002	Supplement 12Manufacturing	Approved	None posted
Jun 28, 2001	Supplement 8Labeling	Approved	None posted
Jun 28, 2001	Supplement 7Manufacturing	Approved	None posted
Jun 28, 2001	Supplement 6Manufacturing	Approved	None posted
Jun 28, 2001	Supplement 5Manufacturing	Approved	Review
Jan 5, 2001	Supplement 4Manufacturing	Approved	None posted
Oct 10, 2000	Supplement 3Manufacturing	Approved	None posted
Aug 9, 2000	Supplement 2Labeling	Approved	None posted
Aug 9, 2000	Supplement 1Manufacturing	Approved	Review
Nov 20, 1998	Original application	Approved	Label Review Letter

Identifiers

Application: ANDA 74726
Drugs@FDA: Overview at FDA
Company: Upsher-Smith Laboratories

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