Treats migraine attacks with or without aura. ANDA 202964, held by Ph Health. Diclofenac Potassium.
As of Nov 15, 2026, ANDA 202964 (Diclofenac Potassium), held by Ph Health, was first approved by FDA on May 2, 2016, with 4 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 2, 2016 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Diclofenac Potassium50MG · for solution;oral | Diclofenac Potassium | Rx |
| Nov 10, 2026 | Supplement 6Labeling · Standard review | Approved | None posted |
| May 1, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 9, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 9, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| May 2, 2016 | Original application | 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
