Potassium Chloride

ANDA 200185, held by Padagis US. Potassium Chloride.

As of Nov 15, 2026, ANDA 200185 (Potassium Chloride), held by Padagis US, was first approved by FDA on May 18, 2011, with 3 approved supplements and 0 published complete response letters.

First approved: May 18, 2011
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
May 18, 2011	Original application	Approved	None posted

Products

2 strengths and forms


Potassium Chloride8MEQ · capsule, extended release;oral	Potassium Chloride	Discontinued
Potassium Chloride10MEQ · capsule, extended release;oral	Potassium Chloride	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jun 10, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Apr 14, 2015	Supplement 1Labeling	Approved	None posted
May 18, 2011	Original application	Approved	None posted
May 18, 2011	Supplement 18	Approved	None posted

Identifiers

Application: ANDA 200185
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