Treats migraine attacks with or without aura. ANDA 217010, held by Umedica. Diclofenac Potassium.
As of Nov 15, 2026, ANDA 217010 (Diclofenac Potassium), held by Umedica, was first approved by FDA on Aug 29, 2025, with 0 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE Diclofenac potassium for oral solution is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Limitations of Use: Diclofenac potassium for oral solution is not indicated for the prophylactic therapy of migraine. The safety and effectiveness of diclofenac potassium for oral solution have not been established for cluster headache, which is present in an older, predominantly male population. Diclofenac potassium for oral solution is a non-steroidal anti-inflammatory drug (NSAID)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 29, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Diclofenac Potassium50MG · for solution;oral | Diclofenac Potassium | Rx |
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
