Application Nr Approved Date Route Status External Links
ANDA200142 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage 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 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 Tablet Treatment. The Efficacy Of Acamprosate Calcium In Promoting Abstinence From Alcohol In Polysubstance Abusers Has Not Been Adequately Assessed. 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 ( 1 ).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Acamprosate Calcium ACAMPROSATE CALCIUM ZINC1554588

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