Treats manic episodes of Bipolar Disorder. ANDA 205532, held by Heritage Pharma. Lithium Carbonate.
As of Nov 15, 2026, ANDA 205532 (Lithium Carbonate), held by Heritage Pharma, was first approved by FDA on Sep 29, 2016, with 5 approved supplements and 0 published complete response letters.
INDICATIONS 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 29, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lithium Carbonate300MG · tablet, extended release;oral | Lithium Carbonate | Rx |
| Apr 21, 2025 | Supplement 9Labeling · Standard review | Approved | None posted |
| Apr 21, 2025 | Supplement 14Labeling · 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 |
| May 6, 2019 | Supplement 2Manufacturing | Approved | None posted |
| Sep 29, 2016 | 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
