Potassium Chloride

ANDA 73531, held by Teva. Potassium Chloride.

As of Nov 15, 2026, ANDA 73531 (Potassium Chloride), held by Teva, was first approved by FDA on Apr 26, 1996, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 26, 1996
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Apr 26, 1996	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Potassium Chloride8MEQ · capsule, extended release;oral	Potassium Chloride	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Sep 18, 1998	Supplement 4Manufacturing	Approved	None posted
Dec 10, 1997	Supplement 3Manufacturing	Approved	None posted
Dec 10, 1997	Supplement 2Manufacturing	Approved	None posted
Jun 18, 1997	Supplement 1Manufacturing	Approved	None posted
Apr 26, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 73531
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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