Potassium Chloride

ANDA 76044, held by Nesher Pharms. Potassium Chloride.

As of Nov 15, 2026, ANDA 76044 (Potassium Chloride), held by Nesher Pharms, was first approved by FDA on Apr 5, 2002, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 5, 2002
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Apr 5, 2002	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Potassium Chloride20MEQ · tablet, extended release;oral	Potassium Chloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Oct 2, 2002	Supplement 2Labeling	Approved	None posted
Oct 2, 2002	Supplement 1Manufacturing	Approved	None posted
Apr 5, 2002	Original application	Approved	Letter

Identifiers

Application: ANDA 76044
Drugs@FDA: Overview at FDA
Company: Nesher Pharmaceuticals

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