Treats manic episodes of manic-depressive illness. ANDA 91616, held by Glenmark Pharms Ltd. Lithium Carbonate.
As of Nov 15, 2026, ANDA 91616 (Lithium Carbonate), held by Glenmark Pharms Ltd, was first approved by FDA on Feb 14, 2011, with 4 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 |
|---|---|---|---|
| Feb 14, 2011 | 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 9Labeling · Standard review | Approved | None posted |
| Dec 20, 2018 | Supplement 8Labeling · Standard review | Approved | None posted |
| Dec 7, 2018 | Supplement 7Labeling · Standard review | Approved | None posted |
| Feb 14, 2011 | 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
