Potassium Chloride

ANDA 75604, held by Actavis Labs Fl Inc. Potassium Chloride.

First approved: Apr 10, 2002
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 10, 2002	Original application	Approved	Letter

Products

2 strengths and forms

Product	Active ingredient	Marketing
Potassium Chloride10MEQ · tablet, extended release;oral	Potassium Chloride	Rx
Potassium Chloride20MEQ · tablet, extended release;oral	Potassium Chloride	Rx

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 24, 2008	Supplement 15Labeling	Approved	None posted
Dec 24, 2002	Supplement 3Manufacturing	Approved	None posted
Nov 29, 2002	Supplement 1Manufacturing	Approved	None posted
Oct 9, 2002	Supplement 2Manufacturing	Approved	None posted
Apr 10, 2002	Original application	Approved	Letter

Identifiers

Application: ANDA 75604
Drugs@FDA: Overview at FDA
Company: Actavis Laboratories FL

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters