NDA 204623, held by Horizon. Diclofenac Sodium.
As of Nov 13, 2026, NDA 204623 (Pennsaid), held by Horizon, was first approved by FDA on Jan 16, 2014, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 16, 2014 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pennsaid2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;topical | Diclofenac Sodium | DiscontinuedReference drug |
| Nov 21, 2024 | Supplement 13Labeling · Standard review | Approved | |
| Jan 27, 2022 | Supplement 9Labeling · Standard review | Approved | |
| Jun 7, 2021 | Supplement 10Labeling · Standard review | Approved | |
| Apr 28, 2021 | Supplement 11Labeling · Standard review | Approved | |
| Oct 31, 2016 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Aug 11, 2016 | Supplement 6Labeling · Standard review | Approved | |
| May 9, 2016 | Supplement 5Labeling · Standard review | Approved | |
| May 6, 2015 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Nov 5, 2014 | Supplement 3Labeling · Standard review | Approved | |
| Jul 21, 2014 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jul 10, 2014 | Supplement 2Manufacturing · Standard review | Approved | |
| Jan 16, 2014 | 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
