Treats primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis…. ANDA 218783, held by Rising. Dichlorphenamide.
As of Nov 14, 2026, ANDA 218783 (Dichlorphenamide), held by Rising, was first approved by FDA on Nov 18, 2025, with 0 approved supplements and 0 published complete response letters.
Dichlorphenamide tablets are indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 18, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dichlorphenamide50MG · tablet;oral | Dichlorphenamide | 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
