Potassium Chloride

ANDA 70980, held by Nesher Pharms. Potassium Chloride.

As of Nov 15, 2026, ANDA 70980 (Potassium Chloride), held by Nesher Pharms, was first approved by FDA on Feb 17, 1987, with 19 approved supplements and 0 published complete response letters.

First approved: Feb 17, 1987
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Feb 17, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Potassium Chloride10MEQ · capsule, extended release;oral	Potassium Chloride	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Mar 13, 2002	Supplement 26Manufacturing	Approved	None posted
Nov 30, 2000	Supplement 21Labeling	Approved	None posted
Nov 30, 2000	Supplement 20Manufacturing	Approved	None posted
Nov 30, 2000	Supplement 19Manufacturing	Approved	None posted
Sep 25, 2000	Supplement 22Manufacturing	Approved	None posted
Mar 4, 1999	Supplement 18Manufacturing	Approved	None posted
Jun 30, 1998	Supplement 17Manufacturing	Approved	None posted
Apr 16, 1993	Supplement 14Manufacturing	Approved	None posted
Dec 22, 1992	Supplement 12Manufacturing	Approved	None posted
Aug 19, 1992	Supplement 13Manufacturing	Approved	None posted
Feb 28, 1992	Supplement 11Labeling	Approved	None posted
Feb 28, 1992	Supplement 10Manufacturing	Approved	None posted
Feb 28, 1992	Supplement 9Manufacturing	Approved	None posted
Dec 6, 1991	Supplement 6Manufacturing	Approved	None posted
Feb 28, 1991	Supplement 8Labeling	Approved	None posted
Feb 15, 1991	Supplement 7Manufacturing	Approved	None posted
May 25, 1990	Supplement 5Manufacturing	Approved	None posted
Dec 22, 1989	Supplement 3Labeling	Approved	None posted
Dec 22, 1989	Supplement 2Manufacturing	Approved	None posted
Feb 17, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 70980
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