Application Nr Approved Date Route Status External Links
ANDA202288 2012-06-29 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Lithium Carbonate Extended-Release Tablets Are Indicated In The Treatment Of Manic Episodes Of Bipolar Disorder. Bipolar Disorder, Manic (dsm-Iv) Is Equivalent To Manic Depressive Illness, Manic, In The Older Dsm-Ii Terminology. Lithium Carbonate Extended-Release Tablets Are Also Indicated As A Maintenance Treatment For Individuals With A Diagnosis Of Bipolar Disorder. Maintenance Therapy Reduces The Frequency Of Manic Episodes And Diminishes The Intensity Of Those Episodes Which May Occur. Typical Symptoms Of Mania Include Pressure Of Speech, Motor Hyperactivity, Reduced Need For Sleep, Flight Of Ideas, Grandiosity, Elation, Poor Judgment, Aggressiveness, And Possibly Hostility. When Given To A Patient Experiencing A Manic Episode, Lithium May Produce A Normalization Of Symptomatology Within 1 To 3 Weeks.

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
3. Povidones POVIDONES Unresolved
4. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
5. Ferric Oxide Red FERRIC OXIDE RED Molecular
6. Sodium Chloride SODIUM CHLORIDE Unresolved GRAS-Generally recognized as safe.
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.
8. Sorbitol SORBITOL Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
9. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
10. Triacetin TRIACETIN Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Lithium Carbonate LITHIUM CARBONATE ZINC895081

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