Application Nr Approved Date Route Status External Links
ANDA204445 2015-06-10 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, Usp Is 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, Usp Is 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 (7 Total)

Name Structure Kind Function Status
1. Carnauba Wax CARNAUBA WAX Unresolved MISC-Miscellaneous GRAS-Generally recognized as safe.
2. Povidones POVIDONES Unresolved
3. Sodium Chloride SODIUM CHLORIDE Unresolved GRAS-Generally recognized as safe.
4. 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.
5. Sorbitol SORBITOL Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
6. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
7. Hypromelloses HYPROMELLOSES Unresolved

Active Ingredients ( 1 Total)

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

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