FDA Orange Book · active-ingredient family
Lithium citrate
Lithium citrate: 2 brands, 3 generics; first approved May 21, 1986; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 3 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
3
Listed patents
0
Presentations
5
Brand (NDA) products
Originator applications
- LITHIUM CITRATERLDHIKMANDA 018421—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG CARBONATE/5ML SYRUP ORAL Discontinued — - SOLVAYNDA 017672—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG CARBONATE/5ML SYRUP ORAL Discontinued —
Generic (ANDA) products (3)
Abbreviated applications
- LITHIUM CITRATESCIEGEN PHARMSANDA 2171832024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG CARBONATE/5ML SYRUP ORAL Rx AA - LITHIUM CITRATERSRUBICON RESEARCHANDA 2180362023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG CARBONATE/5ML SYRUP ORAL Rx AA - LITHIUM CITRATEPAI HOLDINGS PHARMANDA 0707551986
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG CARBONATE/5ML SYRUP ORAL Rx AA
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
41 yr ago
Most recent approval
2 yr 7 mo ago
Approvals span 1986–2024 across 5 FDA applications.
Brand (NDA) 240%
Generic (ANDA) 360%
Lithium citrate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
