Arthrotec

Treats osteoarthritis or rheumatoid arthritis. NDA 20607, held by Pfizer. Diclofenac Sodium; Misoprostol.

As of Nov 13, 2026, NDA 20607 (Arthrotec), held by Pfizer, was first approved by FDA on Dec 24, 1997, with 24 approved supplements and 0 published complete response letters.

First approved: Dec 24, 1997
Review: Standard
Supplements approved: 24
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Diclofenac sodium/misoprostol is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Dec 24, 1997	Original applicationNew combination · Standard review	Approved	Review

Products

2 strengths and forms

Product	Active ingredient	Marketing
Arthrotec50MG;0.2MG · tablet, delayed release;oral	Diclofenac Sodium; Misoprostol	RxReference drug
Arthrotec75MG;0.2MG · tablet, delayed release;oral	Diclofenac Sodium; Misoprostol	RxReference drug

All 25 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 21, 2024	Supplement 43Labeling · Standard review	Approved	Label Medication Guide Letter
Dec 22, 2022	Supplement 41Labeling · Standard review	Approved	Label Letter
Aug 26, 2022	Supplement 40Labeling · Standard review	Approved	Label Letter
Aug 2, 2021	Supplement 39Labeling · Standard review	Approved	Letter Label
Apr 28, 2021	Supplement 38Labeling · Standard review	Approved	Label Letter
Sep 24, 2020	Supplement 36Labeling · Standard review	Approved	Letter Label
Jul 28, 2020	Supplement 33Labeling · Standard review	Approved	Label Letter
May 9, 2016	Supplement 31Labeling · Standard review	Approved	Letter Label
Apr 1, 2015	Supplement 21Labeling · Standard review	Approved	Letter Label
Sep 3, 2014	Supplement 28Labeling · Standard review	Approved	Label Letter
Mar 7, 2013	Supplement 25Labeling · Standard review	Approved	Letter Label
Feb 8, 2013	Supplement 26Manufacturing · Standard review	Approved	None posted
Dec 21, 2010	Supplement 16Labeling	Approved	Letter Label
Sep 11, 2009	Supplement 13Labeling · Standard review	Approved	Letter Label
Feb 25, 2009	Supplement 14Labeling	Approved	Label Letter
Aug 24, 2007	Supplement 10Labeling · Standard review	Approved	Label Letter
Jan 25, 2006	Supplement 9Labeling · Standard review	Approved	Letter Label
Jul 8, 2005	Supplement 8Labeling · Standard review	Approved	Letter
May 20, 2002	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 3, 2000	Supplement 5Labeling · Standard review	Approved	None posted
Feb 22, 1999	Supplement 4Labeling · Standard review	Approved	Review
Jul 20, 1998	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 15, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 16, 1998	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 24, 1997	Original applicationNew combination · Standard review	Approved	Review

Identifiers

Application: NDA 20607
Drugs@FDA: Overview at FDA
Company: Pfizer

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