Last Updated: June 17, 2026

Details for New Drug Application (NDA): 070755

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NDA 070755 describes LITHIUM CITRATE, which is a drug marketed by Hikma, Pai Holdings Pharm, Rubicon Research, and Sciegen Pharms, and is included in four NDAs. It is available from five suppliers. Additional details are available on the LITHIUM CITRATE profile page.

The generic ingredient in LITHIUM CITRATE is lithium citrate. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the lithium citrate profile page.

Summary for 070755

Tradename:	LITHIUM CITRATE
Applicant:	Pai Holdings Pharm
Ingredient:	lithium citrate
Patents:	0

Pharmacology for NDA: 070755

Suppliers and Packaging for NDA: 070755

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LITHIUM CITRATE	lithium citrate	SYRUP;ORAL	070755	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1027	0121-1027-16	500 mL in 1 BOTTLE (0121-1027-16)
LITHIUM CITRATE	lithium citrate	SYRUP;ORAL	070755	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-4027	0121-4027-94	3 TRAY in 1 CASE (0121-4027-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4027-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	EQ 300MG CARBONATE/5ML
Approval Date:	May 21, 1986	TE:	AA	RLD:	No

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