Diclofenac Sodium

Relieves osteoarthritis for relief of the signs and symptoms of rheumatoid arthritis for…. ANDA 74514, held by Actavis Elizabeth. Diclofenac Sodium.

As of Nov 13, 2026, ANDA 74514 (Diclofenac Sodium), held by Actavis Elizabeth, was first approved by FDA on Mar 26, 1996, with 18 approved supplements and 0 published complete response letters.

First approved: Mar 26, 1996
Supplements approved: 18
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 sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac sodium delayed-release tablets are indicated: for relief of the signs and symptoms of osteoarthritis for relief of the signs and symptoms of rheumatoid arthritis for acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Mar 26, 1996	Original application	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Diclofenac Sodium50MG · tablet, delayed release;oral	Diclofenac Sodium	Rx
Diclofenac Sodium75MG · tablet, delayed release;oral	Diclofenac Sodium	Rx

All 19 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 21, 2024	Supplement 48Labeling · Standard review	Approved	None posted
Jul 11, 2024	Supplement 46Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 44Labeling · Standard review	Approved	None posted
Mar 31, 2021	Supplement 41Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 37Labeling · Standard review	Approved	None posted
Nov 7, 2014	Supplement 30Labeling	Approved	None posted
May 11, 2009	Supplement 25Labeling	Approved	None posted
May 8, 2008	Supplement 23Labeling	Approved	None posted
Jul 28, 2006	Supplement 16Labeling	Approved	None posted
Jul 1, 2004	Supplement 11Labeling	Approved	None posted
Feb 20, 2004	Supplement 9Labeling	Approved	None posted
Feb 21, 2002	Supplement 7Manufacturing	Approved	None posted
Nov 2, 2001	Supplement 6Manufacturing	Approved	None posted
Jul 13, 2001	Supplement 5Manufacturing	Approved	None posted
Feb 16, 2001	Supplement 4Manufacturing	Approved	None posted
Dec 4, 2000	Supplement 3Manufacturing	Approved	None posted
Jun 2, 2000	Supplement 2Manufacturing	Approved	None posted
Mar 12, 1998	Supplement 1Manufacturing	Approved	None posted
Mar 26, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74514
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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