For alcohol dependence. ANDA 205995, held by Zydus Pharms. Acamprosate Calcium.
As of Nov 15, 2026, ANDA 205995 (Acamprosate Calcium), held by Zydus Pharms, was first approved by FDA on May 26, 2017, with 0 approved supplements and 0 published complete response letters.
Acamprosate calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation ( 1, 14 ). Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 26, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acamprosate Calcium333MG · tablet, delayed release;oral | Acamprosate Calcium | 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
