Treats migraine attacks with or without aura. ANDA 216635, held by Alkem Labs Ltd. Diclofenac Potassium.
As of Nov 15, 2026, ANDA 216635 (Diclofenac Potassium), held by Alkem Labs Ltd, was first approved by FDA on Jul 20, 2022, with 1 approved supplement 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 |
|---|---|---|---|
| Jul 20, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Diclofenac Potassium50MG · for solution;oral | Diclofenac Potassium | Rx |
| Dec 14, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 20, 2022 | Original application | Approved | None posted |
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
