Treats manic episodes of manic-depressive illness. ANDA 205663, held by Unique. Lithium Carbonate.
As of Nov 15, 2026, ANDA 205663 (Lithium Carbonate), held by Unique, was first approved by FDA on Jun 5, 2017, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Lithium Carbonate Extended-Release Tablets is indicated in the treatment of manic episodes of manic-depressive illness. Maintenance therapy prevents or diminishes the intensity of subsequent episodes in those manic-depressive patients with a history of mania. 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 Carbonate Extended-Release Tablets may produce a normalization of symptomatology within 1 to 3 weeks.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 5, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lithium Carbonate450MG · tablet, extended release;oral | Lithium Carbonate | Rx |
| Oct 13, 2022 | Supplement 9Labeling · Standard review | Approved | None posted |
| Feb 28, 2020 | Supplement 5Labeling · Standard review | Approved | None posted |
| Dec 20, 2018 | Supplement 2Labeling · Standard review | Approved | None posted |
| Dec 7, 2018 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 5, 2017 | 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
