FDA — authorised 23 December 1980
- Marketing authorisation holder: ROXANE
- Status: approved
🇺🇸 Lithium Citrate in United States
FDA authorised Lithium Citrate on 23 December 1980
Marketing authorisations
FDA — authorised 23 December 1980
- Application: NDA018421
- Marketing authorisation holder: HIKMA
- Local brand name: LITHIUM CITRATE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 21 May 1986
- Application: ANDA070755
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: LITHIUM CITRATE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 14 August 2023
- Application: ANDA218036
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: LITHIUM CITRATE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 18 March 2024
- Application: ANDA217183
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: LITHIUM CITRATE
- Indication: SYRUP — ORAL
- Status: approved
FDA
- Application: NDA017672
- Marketing authorisation holder: SOLVAY
- Local brand name: LITHONATE
- Indication: SYRUP — ORAL
- Status: approved
Lithium Citrate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Lithium Citrate approved in United States?
Yes. FDA authorised it on 23 December 1980; FDA authorised it on 23 December 1980; FDA authorised it on 21 May 1986.
Who is the marketing authorisation holder for Lithium Citrate in United States?
ROXANE holds the US marketing authorisation.