Treats primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis…. ANDA 215924, held by Torrent. Dichlorphenamide.
As of Nov 14, 2026, ANDA 215924 (Ormalvi), held by Torrent, was first approved by FDA on Dec 29, 2022, with 1 approved supplement and 0 published complete response letters.
ORMALVI is indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 29, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ormalvi50MG · tablet;oral | Dichlorphenamide | Rx |
| Feb 8, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 29, 2022 | 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
