NDA 204592, held by Zyla. Diclofenac.
As of Nov 13, 2026, NDA 204592 (Zorvolex), held by Zyla, was first approved by FDA on Oct 18, 2013, with 9 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 22, 2014 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Oct 18, 2013 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zorvolex18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Diclofenac | DiscontinuedReference drug |
| Zorvolex35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Diclofenac | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 21, 2024 | Supplement 14Labeling · Standard review | Approved | |
| Apr 28, 2021 | Supplement 13Labeling · Standard review | Approved | |
| May 9, 2016 | Supplement 7Labeling · Standard review | Approved | |
| May 9, 2016 | Supplement 8Labeling · Standard review | Approved | |
| Jan 29, 2015 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Aug 22, 2014 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Aug 22, 2014 | Supplement 4Labeling · Standard review | Approved | |
| Aug 11, 2014 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Apr 14, 2014 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Oct 18, 2013 | 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
