Diclofenac Potassium

Treats primary dysmenorrhea for relief of mild to moderate pain for relief of the signs…. ANDA 75219, held by Teva. Diclofenac Potassium.

As of Nov 15, 2026, ANDA 75219 (Diclofenac Potassium), held by Teva, was first approved by FDA on Aug 6, 1998, with 13 approved supplements and 0 published complete response letters.

First approved: Aug 6, 1998
Supplements approved: 13
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 14 submissions below

Date	Submission	Status	Documents
Aug 6, 1998	Original application	Approved	Letter

Products

1 strengths and forms

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

All 14 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 22Labeling · Standard review	Approved	None posted
Sep 26, 2024	Supplement 20Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 19Labeling · Standard review	Approved	None posted
Apr 1, 2021	Supplement 14Labeling · Standard review	Approved	None posted
Dec 5, 2014	Supplement 13Labeling	Approved	None posted
May 21, 2009	Supplement 12Labeling	Approved	None posted
May 19, 2006	Supplement 10Labeling	Approved	None posted
Mar 13, 2006	Supplement 9Labeling	Approved	None posted
Aug 22, 2002	Supplement 7Labeling	Approved	None posted
Feb 1, 2000	Supplement 5Manufacturing	Approved	None posted
Feb 1, 2000	Supplement 6Manufacturing	Approved	None posted
Dec 2, 1999	Supplement 3Manufacturing	Approved	None posted
Dec 2, 1999	Supplement 4Manufacturing	Approved	None posted
Aug 6, 1998	Original application	Approved	Letter

Identifiers

Application: ANDA 75219
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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