Potassium Chloride

ANDA 205549, held by Strides Pharma. Potassium Chloride.

As of Nov 15, 2026, ANDA 205549 (Potassium Chloride), held by Strides Pharma, was first approved by FDA on Dec 8, 2015, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 8, 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
Dec 8, 2015	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 2 submissions, including labeling and manufacturing supplements


Apr 21, 2025	Supplement 1Labeling · Standard review	Approved	None posted
Dec 8, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 205549
Drugs@FDA: Overview at FDA
Company: Strides Pharma Inc

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