Potassium Chloride

ANDA 205993, held by Padagis US. Potassium Chloride.

As of Nov 15, 2026, ANDA 205993 (Potassium Chloride), held by Padagis US, was first approved by FDA on Nov 5, 2015, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 5, 2015
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 5, 2015	Original application	Approved	None posted

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Apr 26, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Nov 5, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 205993
Drugs@FDA: Overview at FDA
Company: Padagis US LLC

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