Relieves mild to moderate acute pain. NDA 22202, held by Cosette. Diclofenac Potassium.
As of Nov 13, 2026, NDA 22202 (Zipsor), held by Cosette, was first approved by FDA on Jun 16, 2009, with 8 approved supplements and 0 published complete response letters.
Diclofenac Potassium is indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older.
| May 25, 2021 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Jun 16, 2009 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zipsor25MG · capsule;oral | Diclofenac Potassium | RxReference drug |
| Nov 21, 2024 | Supplement 16Labeling · Standard review | Approved | |
| May 25, 2021 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| May 25, 2021 | Supplement 14Labeling · Standard review | Approved | |
| May 9, 2016 | Supplement 11Labeling · Standard review | Approved | |
| Dec 16, 2015 | Supplement 10Labeling · Standard review | Approved | None posted |
| Aug 7, 2015 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| May 4, 2011 | Supplement 3REMS | Approved | |
| May 4, 2011 | Supplement 4REMS | Approved | |
| Jun 16, 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
