Treats manic episodes of manic-depressive illness. ANDA 76691, held by Hikma. Lithium Carbonate.
As of Nov 15, 2026, ANDA 76691 (Lithium Carbonate), held by Hikma, was first approved by FDA on Jan 5, 2004, with 5 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Lithium Carbonate Extended-Release Tablets are 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 |
|---|---|---|---|
| Jan 5, 2004 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lithium Carbonate450MG · tablet, extended release;oral | Lithium Carbonate | Rx |
| Oct 13, 2022 | Supplement 12Labeling · Standard review | Approved | None posted |
| Feb 5, 2020 | Supplement 10Labeling · Standard review | Approved | None posted |
| Dec 20, 2018 | Supplement 9Labeling · Standard review | Approved | None posted |
| Dec 7, 2018 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jan 27, 2012 | Supplement 6Labeling | Approved | None posted |
| Jan 5, 2004 | 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
