ANDA 91260, held by Apotex Inc. Cevimeline Hydrochloride.
As of Nov 14, 2026, ANDA 91260 (Cevimeline Hydrochloride), held by Apotex Inc, was first approved by FDA on Aug 25, 2011, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 25, 2011 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cevimeline Hydrochloride30MG ยท capsule;oral | Cevimeline Hydrochloride | Discontinued |
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
