Treats manic episodes of Bipolar Disorder. ANDA 76832, held by Hikma. Lithium Carbonate.
As of Nov 15, 2026, ANDA 76832 (Lithium Carbonate), held by Hikma, was first approved by FDA on Oct 28, 2004, with 7 approved supplements and 0 published complete response letters.
INDICATIONS Lithium carbonate 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 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 28, 2004 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lithium Carbonate300MG · tablet, extended release;oral | Lithium Carbonate | Rx |
| Jul 13, 2026 | Supplement 15Labeling · Standard review | Approved | None posted |
| Feb 14, 2020 | Supplement 11Labeling · Standard review | Approved | None posted |
| Feb 14, 2020 | Supplement 12Labeling · Standard review | Approved | None posted |
| Feb 14, 2020 | Supplement 13Labeling · Standard review | Approved | None posted |
| Mar 6, 2012 | Supplement 9Labeling | Approved | None posted |
| Dec 26, 2007 | Supplement 5Labeling | Approved | None posted |
| Sep 28, 2007 | Supplement 3Labeling | Approved | None posted |
| Oct 28, 2004 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
