Treats symptoms of dry mouth. ANDA 215056, held by Aurobindo Pharma. Cevimeline Hydrochloride.
As of Nov 14, 2026, ANDA 215056 (Cevimeline Hydrochloride), held by Aurobindo Pharma, was first approved by FDA on Apr 18, 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 |
|---|---|---|---|
| Apr 18, 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
