Acamprosate Calcium

ANDA 200143, held by Barr Labs Div Teva. Acamprosate Calcium.

As of Nov 15, 2026, ANDA 200143 (Acamprosate Calcium), held by Barr Labs Div Teva, was first approved by FDA on Nov 18, 2013, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 18, 2013
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 18, 2013	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acamprosate Calcium333MG · tablet, delayed release;oral	Acamprosate Calcium	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Aug 22, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Nov 18, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 200143
Drugs@FDA: Overview at FDA
Company: Barr Laboratories

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