Treats symptoms of dry mouth. ANDA 203775, held by Rising. Cevimeline Hydrochloride.
As of Nov 15, 2026, ANDA 203775 (Cevimeline Hydrochloride), held by Rising, was first approved by FDA on Jun 4, 2014, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Cevimeline is indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 4, 2014 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cevimeline Hydrochloride30MG · capsule;oral | Cevimeline Hydrochloride | Rx |
| Jul 24, 2025 | Supplement 4Manufacturing | Approved | None posted |
| Jun 4, 2014 | 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
