Diclofenac Potassium

Treats primary dysmenorrhea for relief of mild to moderate pain for relief of the signs…. ANDA 75229, held by Rubicon Research. Diclofenac Potassium.

As of Nov 15, 2026, ANDA 75229 (Diclofenac Potassium), held by Rubicon Research, was first approved by FDA on Nov 20, 1998, with 14 approved supplements and 0 published complete response letters.

First approved: Nov 20, 1998
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac potassium tablets are indicated: for treatment of primary dysmenorrhea for relief of mild to moderate pain for relief of the signs and symptoms of osteoarthritis for relief of the signs and symptoms of rheumatoid arthritis

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Nov 20, 1998	Original application	Approved	Letter

Products

3 strengths and forms


Diclofenac Potassium50MG · tablet;oral	Diclofenac Potassium	Rx
Diclofenac Potassium25MG · tablet;oral	Diclofenac Potassium	Rx
Diclofenac Potassium75MG · tablet;oral	Diclofenac Potassium	Rx

All 15 submissions, including labeling and manufacturing supplements


Sep 18, 2026	Supplement 33Manufacturing	Approved	None posted
Nov 21, 2024	Supplement 35Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 23Labeling · Standard review	Approved	None posted
Apr 26, 2021	Supplement 20Labeling · Standard review	Approved	None posted
Dec 6, 2014	Supplement 16Labeling	Approved	None posted
Sep 4, 2009	Supplement 14Labeling	Approved	None posted
Apr 29, 2008	Supplement 12Labeling	Approved	None posted
Oct 5, 2006	Supplement 11Labeling	Approved	None posted
Oct 2, 2002	Supplement 3Manufacturing	Approved	None posted
Oct 2, 2002	Supplement 4Manufacturing	Approved	None posted
Oct 2, 2002	Supplement 5Manufacturing	Approved	None posted
Sep 10, 2002	Supplement 6Labeling	Approved	None posted
Mar 18, 2002	Supplement 1Manufacturing	Approved	None posted
Mar 18, 2002	Supplement 2Manufacturing	Approved	None posted
Nov 20, 1998	Original application	Approved	Letter

Identifiers

Application: ANDA 75229
Drugs@FDA: Overview at FDA
Company: Rubicon Research

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