Diclofenac Potassium

ANDA 75582, held by Chartwell Rx. Diclofenac Potassium.

As of Nov 15, 2026, ANDA 75582 (Diclofenac Potassium), held by Chartwell Rx, was first approved by FDA on Feb 23, 2001, with 4 approved supplements and 0 published complete response letters.

First approved: Feb 23, 2001
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
Feb 23, 2001	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Diclofenac Potassium50MG · tablet;oral	Diclofenac Potassium	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Nov 20, 2023	Supplement 7Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 5Labeling · Standard review	Approved	None posted
Mar 31, 2021	Supplement 4Labeling · Standard review	Approved	None posted
Feb 23, 2001	Original application	Approved	Letter

Identifiers

Application: ANDA 75582
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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