NDA 20947, held by Nuvo Pharms Inc. Diclofenac Sodium.
As of Nov 13, 2026, NDA 20947 (Pennsaid), held by Nuvo Pharms Inc, was first approved by FDA on Nov 4, 2009, with 6 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 4, 2009 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pennsaid1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;topical | Diclofenac Sodium | DiscontinuedReference drug |
| May 9, 2016 | Supplement 10Labeling · Standard review | Approved | |
| May 9, 2016 | Supplement 11Labeling · Standard review | Approved | |
| Oct 21, 2013 | Supplement 8Labeling · Standard review | Approved | |
| Jul 14, 2011 | Supplement 7REMS | Approved | |
| Mar 25, 2010 | Supplement 1Labeling | Approved | |
| Mar 25, 2010 | Supplement 2Labeling | Approved | |
| Nov 4, 2009 | Original applicationNew dosage form · Standard review | Approved |
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
