Treats bipolar I disorder. ANDA 218036, held by Rubicon Research. Lithium Citrate.
As of Nov 14, 2026, ANDA 218036 (Lithium Citrate), held by Rubicon Research, was first approved by FDA on Aug 14, 2023, 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 |
|---|---|---|---|
| Aug 14, 2023 | 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
