Sold as Campral. Every FDA application for this active ingredient: 1 branded and 6 generic.
As of Nov 15, 2026, FDA lists 7 applications for Acamprosate Calcium (sold as Campral), first approved Jul 29, 2004, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Acamprosate Calcium | Part D | $5.3M | -17% | 16,064 |
| A Digital Pill System to Measure and Support Acamprosate Adherence in Individuals With Alcohol Associated Liver DiseaseAlcohol Use Disorder, Alcohol Associated Liver Disease · Yale University | Not applicable | Not yet recruiting | Apr 28, 2026 |
| Acamprosate in C9orf72 Hexanucleotide Repeat Expansion Amyotrophic Lateral Sclerosis (ACALS)Amyotrophic Lateral Sclerosis, Motor Neuron Disease · National Institute of Neurological Disorders and Stroke (NINDS) | Phase 1 | Recruiting | Oct 3, 2025 |
| Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) TrialAlcohol-associated Hepatitis · Samer Gawrieh | Phase 2 | Recruiting | Jul 11, 2025 |
| Combining a Smartphone App With Medications to Manage Heavy DrinkingAlcohol Use Disorder (AUD) · VA Office of Research and Development | Not applicable | Recruiting | Mar 12, 2024 |
| Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use DisorderAlcohol Use Disorder · National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Phase 4 | Recruiting | Feb 21, 2024 |
| Jul 29, 2004 | CampralNDA 21431 · New molecular entity | Forest Labs | 4 | Discontinued |
| Jul 16, 2013 | Acamprosate CalciumANDA 202229 | Glenmark Pharms Ltd | 0 | Marketed |
| Nov 18, 2013 | Acamprosate CalciumANDA 200143 | Barr Labs Div Teva | 1 | Discontinued |
| Mar 11, 2014 | Acamprosate CalciumANDA 200142 | Mylan | 0 | Marketed |
| May 26, 2017 | Acamprosate CalciumANDA 205995 | Zydus Pharms | 0 | Marketed |
| Sep 18, 2025 | Acamprosate CalciumANDA 219904 | Bionpharma | 0 | Marketed |
| Mar 16, 2026 | Acamprosate CalciumANDA 218984 | Somerset Theraps LLC | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Mylan
Zydus Pharms