NDA 21431, held by Forest Labs. Acamprosate Calcium.
As of Nov 14, 2026, NDA 21431 (Campral), held by Forest Labs, was first approved by FDA on Jul 29, 2004, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 29, 2004 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Campral333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, delayed release;oral | Acamprosate Calcium | DiscontinuedReference drug |
| Aug 10, 2015 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Sep 20, 2013 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Jan 30, 2012 | Supplement 15Labeling | Approved | |
| Dec 13, 2010 | Supplement 13Labeling | Approved | |
| Jul 29, 2004 | Original applicationNew molecular entity · Priority review | Approved |
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
