Treats bipolar I disorder. ANDA 91027, held by Sun Pharm Inds Inc. Lithium Carbonate.
As of Nov 15, 2026, ANDA 91027 (Lithium Carbonate), held by Sun Pharm Inds Inc, was first approved by FDA on Jun 24, 2010, with 0 approved supplements and 0 published complete response letters.
Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: Treatment of acute manic and mixed episodes in patients 7 years and older Maintenance treatment in patients 7 years and older
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 24, 2010 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lithium Carbonate300MG · tablet;oral | Lithium Carbonate | Discontinued |
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
