Treats symptoms of dry mouth. ANDA 206808, held by Macleods Pharms. Cevimeline Hydrochloride.
As of Nov 15, 2026, ANDA 206808 (Cevimeline Hydrochloride), held by Macleods Pharms, was first approved by FDA on Sep 20, 2024, with 0 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE Cevimeline is indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 20, 2024 | 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
