Sold as Lithonate, Lithium Citrate. Every FDA application for this active ingredient: 2 branded and 3 generic.
As of Nov 14, 2026, FDA lists 5 applications for Lithium Citrate (sold as Lithonate, Lithium Citrate), first approved Dec 23, 1980, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Lithium Citrate | Part D | $299K | +116% | 537 |
| Smart Sock for Monitoring Walking and Supporting Physical Activity in Older AdultsWalking Mesh · University of Malaya | Not applicable | Not yet recruiting | Oct 28, 2026 |
| Evaluation of Ceramic Dental Crown Clinical Performance After Conventional Hydrofluoric Acid Etching or Gaseous Plasma PretreatmentProsthodontics, Dental Adhesives/Restorations Performance · University of Ljubljana, Faculty of Medicine | Not applicable | Recruiting | Oct 15, 2026 |
| Clinical Comparison of Lithium Disilicate and 3D-Printed Resin EndocrownsEndodontically Treated Teeth, Nonvital Teeth · Medipol University | Not applicable | Active, not recruiting | Oct 15, 2026 |
| Clinical Evaluation of 3D-Printed Resin Versus CAD/CAM-Milled Lithium Disilicate Overlay RestorationsCAD/CAM, 3D-printed · Tanta University | Not applicable | Enrolling by invitation | Oct 1, 2026 |
| Conservative Versus Conventional Restorative Approach for Endodontically Treated Posterior TeethRoot Canal Treated Posterior Teeth, Endodontically-Treated Teeth · Moataz Mostafa Anwar | Not applicable | Recruiting | Sep 23, 2026 |
| An In-vivo Survival Rate of Different Onlay Materials Placed Over Endodontically Treated Molar TeethDental Restoration Failures · Yousef Mahmoud Salem | Not applicable | Active, not recruiting | Aug 10, 2026 |
| Examining Lithium's Mechanism in Bipolar DisorderHealthy, Bipolar · Northumbria University | Not applicable | Not yet recruiting | Aug 6, 2026 |
| Testing a New Gold Nanoparticle-Based Lithium Delivery Method for Bipolar Disorder in Laboratory ModelsBipolar Disorder (BD), Bipolar Disorder (BPD) · Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Not applicable | Not yet recruiting | Jul 29, 2026 |
| Dec 23, 1980 | Lithium CitrateNDA 18421 · New formulation or manufacturer | Hikma | 26 | Discontinued |
| May 21, 1986 | Lithium CitrateANDA 70755 | Pai Holdings Pharm | 13 | Marketed |
| Aug 14, 2023 | Lithium CitrateANDA 218036 | Rubicon Research | 0 | Marketed |
| Mar 18, 2024 | Lithium CitrateANDA 217183 | Sciegen Pharms | 0 | Marketed |
| — | LithonateNDA 17672 | Solvay | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA