Treats symptoms of dry mouth. ANDA 91591, held by Hikma. Cevimeline Hydrochloride.
As of Nov 15, 2026, ANDA 91591 (Cevimeline Hydrochloride), held by Hikma, was first approved by FDA on Jul 8, 2013, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Cevimeline hydrochloride is indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 8, 2013 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cevimeline Hydrochloride30MG · capsule;oral | Cevimeline Hydrochloride | 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
