For alcohol dependence. ANDA 200142, held by Mylan. Acamprosate Calcium.
As of Nov 15, 2026, ANDA 200142 (Acamprosate Calcium), held by Mylan, was first approved by FDA on Mar 11, 2014, 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. Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support. The efficacy of acamprosate calcium delayed-release tablets in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning acamprosate calcium delayed-release tablets treatment.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 11, 2014 | 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
