Voltaren

NDA 20037, held by Novartis. Diclofenac Sodium.

As of Nov 14, 2026, NDA 20037 (Voltaren), held by Novartis, was first approved by FDA on Mar 28, 1991, with 17 approved supplements and 0 published complete response letters.

First approved: Mar 28, 1991
Review: Priority
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


Feb 25, 1998	Supplement 8Efficacy (new indication or use) · Standard review	Approved	None posted
Jul 23, 1996	Supplement 7Efficacy (new indication or use) · Standard review	Approved	None posted
Mar 28, 1991	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Voltaren0.1% · solution/drops;ophthalmic	Diclofenac Sodium	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


Sep 13, 2012	Supplement 31Labeling · Standard review	Approved	Letter Label
Apr 8, 2011	Supplement 23Labeling · Standard review	Approved	Letter Label
Sep 4, 2007	Supplement 14Labeling · Standard review	Approved	Label Letter
Oct 1, 2002	Supplement 17Manufacturing · Priority review	Approved	None posted
Apr 9, 2002	Supplement 16Manufacturing · Priority review	Approved	None posted
Oct 12, 2001	Supplement 15Manufacturing · Priority review	Approved	None posted
Dec 26, 2000	Supplement 13Manufacturing · Priority review	Approved	None posted
Oct 27, 2000	Supplement 12Manufacturing · Priority review	Approved	None posted
Aug 5, 1998	Supplement 10Manufacturing · Priority review	Approved	None posted
Feb 25, 1998	Supplement 8Efficacy (new indication or use) · Standard review	Approved	None posted
Nov 19, 1997	Supplement 6Manufacturing · Priority review	Approved	None posted
Jul 23, 1996	Supplement 7Efficacy (new indication or use) · Standard review	Approved	None posted
May 3, 1995	Supplement 5Labeling · Standard review	Approved	None posted
Mar 15, 1995	Supplement 4Manufacturing · Priority review	Approved	None posted
Mar 15, 1995	Supplement 3Manufacturing · Priority review	Approved	None posted
Dec 8, 1992	Supplement 2Manufacturing · Priority review	Approved	None posted
Jan 9, 1992	Supplement 1Labeling	Approved	None posted
Mar 28, 1991	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 20037
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