Treats manic episodes of Bipolar Disorder. ANDA 204779, held by Unique. Lithium Carbonate.
As of Nov 15, 2026, ANDA 204779 (Lithium Carbonate), held by Unique, was first approved by FDA on Jul 27, 2015, with 5 approved supplements and 0 published complete response letters.
INDICATIONS Lithium carbonate extended-release tablets 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 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 |
|---|---|---|---|
| Jul 27, 2015 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lithium Carbonate300MG · tablet, extended release;oral | Lithium Carbonate | Rx |
| Apr 2, 2025 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jul 13, 2020 | Supplement 6Labeling · Standard review | Approved | None posted |
| Feb 14, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 14, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 14, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jul 27, 2015 | Original application | Approved | None posted |
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
