Application Nr Approved Date Route Status External Links
ANDA205995 2017-05-26 Oral RX 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 (1, 14). Treatment With Acamprosate Calcium Delayed-Release Tablets Should Be Part Of A Comprehensive Management Program That Includes Psychosocial Support (1). 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. The Efficacy Of Acamprosate Calcium Delayed-Release Tablets In Promoting Abstinence From Alcohol In Polysubstance Abusers Has Not Been Adequately Assessed.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A Unresolved
2. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
3. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
4. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
5. Povidones POVIDONES Unresolved
6. Sodium Bicarbonate SODIUM BICARBONATE Molecular MISC-Miscellaneous , SANI-Sanitizing agent REG-Food additives for which a petition has been filed and a regulation issued.
7. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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

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