Diclofenac Potassium

Treats primary dysmenorrhea. ANDA 75463, held by Rising. Diclofenac Potassium.

As of Nov 15, 2026, ANDA 75463 (Diclofenac Potassium), held by Rising, was first approved by FDA on Jul 26, 1999, with 7 approved supplements and 0 published complete response letters.

First approved: Jul 26, 1999
Supplements approved: 7
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 8 submissions below

Date	Submission	Status	Documents
Jul 26, 1999	Original application	Approved	Letter

Products

1 strengths and forms

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

All 8 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 22Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 18Labeling · Standard review	Approved	None posted
Mar 31, 2021	Supplement 14Labeling · Standard review	Approved	None posted
May 14, 2015	Supplement 12Labeling · Standard review	Approved	None posted
Aug 21, 2009	Supplement 11Labeling	Approved	None posted
Oct 16, 2007	Supplement 6Labeling	Approved	None posted
Jun 7, 2006	Supplement 4Labeling	Approved	None posted
Jul 26, 1999	Original application	Approved	Letter

Identifiers

Application: ANDA 75463
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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