Treats symptoms of dry mouth. ANDA 204746, held by Novel Labs Inc. Cevimeline Hydrochloride.
As of Nov 15, 2026, ANDA 204746 (Cevimeline Hydrochloride), held by Novel Labs Inc, was first approved by FDA on Dec 30, 2016, with 0 approved supplements 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 |
|---|---|---|---|
| Dec 30, 2016 | 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
