Treats symptoms of dry mouth. ANDA 218290, held by Bionpharma. Cevimeline Hydrochloride.
As of Nov 15, 2026, ANDA 218290 (Cevimeline Hydrochloride), held by Bionpharma, was first approved by FDA on Nov 8, 2023, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Cevimeline hydrochloride capsules are indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 8, 2023 | 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
