Treats manic episodes of Bipolar Disorder. ANDA 204445, held by Alembic. Lithium Carbonate.
As of Nov 15, 2026, ANDA 204445 (Lithium Carbonate), held by Alembic, was first approved by FDA on Jun 8, 2015, with 4 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 8, 2015 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lithium Carbonate300MG · tablet, extended release;oral | Lithium Carbonate | Discontinued |
| Jul 13, 2020 | Supplement 8Labeling · Standard review | Approved | None posted |
| Feb 14, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 14, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 14, 2020 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jun 8, 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
