Is there a generic for Lithium citrate?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Lithium citrate, referencing the brand LITHIUM CITRATE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Lithium citrate?

LITHIUM CITRATE (NDA 018421, HIKMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Lithium citrate are approved?

Lithium citrate is approved in the following dosage form: syrup.

FDA Orange Book · active-ingredient family

Lithium citrate

Lithium citrate is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:LITHIUM CITRATE · NDA 018421

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · syrup

Product	Applicant	Application	TE	Approved
LITHIUM CITRATERLD	HIKMA	NDA 018421	—	Approved Prior to Jan 1, 1982
LITHONATE	SOLVAY	NDA 017672	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
LITHIUM CITRATE	SCIEGEN PHARMS	ANDA 217183	AA	Mar 18, 2024
LITHIUM CITRATE	RUBICON RESEARCH	ANDA 218036	AA	Aug 14, 2023
LITHIUM CITRATE	PAI HOLDINGS PHARM	ANDA 070755	AA	May 21, 1986

Listed patents

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.

Lithium citrate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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