NDA 19201, held by Novartis. Diclofenac Sodium.
As of Nov 13, 2026, NDA 19201 (Voltaren), held by Novartis, was first approved by FDA on Jul 28, 1988, with 37 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 28, 1988 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Voltaren25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, delayed release;oral | Diclofenac Sodium | DiscontinuedReference drug |
| Voltaren50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, delayed release;oral | Diclofenac Sodium | DiscontinuedReference drug |
| Voltaren75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, delayed release;oral | Diclofenac Sodium | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 28, 2021 | Supplement 48Labeling · Standard review | Approved | |
| May 9, 2016 | Supplement 46Labeling · Standard review | Approved | |
| Jun 5, 2014 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Jan 25, 2013 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Feb 23, 2011 | Supplement 40Labeling · Standard review | Approved | |
| Feb 23, 2011 | Supplement 39Labeling | Approved | |
| Feb 25, 2009 | Supplement 38Labeling · Standard review | Approved | |
| Jul 9, 2007 | Supplement 36Labeling · Standard review | Approved | |
| Jan 24, 2006 | Supplement 35Labeling · Standard review | Approved | |
| Nov 26, 2002 | Supplement 18Labeling · Standard review | Approved | |
| Sep 19, 2002 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Mar 11, 2002 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Oct 31, 2001 | Supplement 23Labeling · Standard review | Approved | None posted |
| Sep 28, 2001 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Oct 23, 2000 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Sep 20, 2000 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Feb 18, 2000 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Apr 22, 1999 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Feb 9, 1999 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Apr 20, 1998 | Supplement 22Labeling · Standard review | Approved | None posted |
| May 16, 1997 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Mar 11, 1997 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Dec 22, 1995 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Nov 2, 1995 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Jul 28, 1995 | Supplement 20Labeling · Standard review | Approved | None posted |
| Dec 8, 1994 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Apr 20, 1993 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jan 4, 1993 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Apr 21, 1992 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Feb 12, 1991 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Feb 12, 1990 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jan 24, 1990 | Supplement 10Labeling | Approved | None posted |
| Sep 27, 1989 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jul 20, 1989 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jul 11, 1989 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Feb 6, 1989 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Dec 30, 1988 | Supplement 4Labeling | Approved | None posted |
| Jul 28, 1988 | Original applicationNew molecular entity · Standard review | Approved | None posted |
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
