Treats bipolar I disorder. ANDA 217183, held by Sciegen Pharms. Lithium Citrate.
As of Nov 14, 2026, ANDA 217183 (Lithium Citrate), held by Sciegen Pharms, was first approved by FDA on Mar 18, 2024, with 0 approved supplements and 0 published complete response letters.
Lithium oral solution 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 |
|---|---|---|---|
| Mar 18, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lithium CitrateEQ 300MG CARBONATE/5ML · syrup;oral | Lithium Citrate | Rx |
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
