Voltaren-Xr

NDA 20254, held by Novartis. Diclofenac Sodium.

As of Nov 13, 2026, NDA 20254 (Voltaren-Xr), held by Novartis, was first approved by FDA on Mar 8, 1996, with 22 approved supplements and 0 published complete response letters.

First approved: Mar 8, 1996
Review: Standard
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Mar 8, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Voltaren-Xr100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Diclofenac Sodium	DiscontinuedReference drug

All 23 submissions, including labeling and manufacturing supplements


Apr 28, 2021	Supplement 30Labeling · Standard review	Approved	Label Medication Guide Letter
May 9, 2016	Supplement 28Labeling · Standard review	Approved	Letter Label
Jun 5, 2014	Supplement 26Manufacturing · Standard review	Approved	None posted
Feb 28, 2014	Supplement 25Manufacturing · Standard review	Approved	None posted
Jan 25, 2013	Supplement 23Manufacturing · Standard review	Approved	None posted
Feb 23, 2011	Supplement 20Labeling · Standard review	Approved	Label Letter
Feb 23, 2011	Supplement 19Labeling	Approved	Label Letter
Feb 25, 2009	Supplement 18Labeling · Standard review	Approved	Label Letter
Jan 24, 2006	Supplement 16Labeling · Standard review	Approved	Review Letter Label
Sep 19, 2002	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 11, 2002	Supplement 12Manufacturing · Standard review	Approved	None posted
Nov 5, 2001	Supplement 11Manufacturing · Standard review	Approved	None posted
Oct 31, 2001	Supplement 2Labeling · Standard review	Approved	None posted
Sep 28, 2001	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 13, 2000	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 23, 2000	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 20, 2000	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 18, 2000	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 22, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
May 16, 1997	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 11, 1997	Supplement 3Manufacturing · Standard review	Approved	None posted
May 21, 1996	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 8, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20254
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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