Lithium Citrate

NDA 18421, held by Hikma. Lithium Citrate.

As of Nov 14, 2026, NDA 18421 (Lithium Citrate), held by Hikma, was first approved by FDA on Dec 23, 1980, with 26 approved supplements and 0 published complete response letters.

First approved: Dec 23, 1980
Review: Standard
Supplements approved: 26
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
Dec 23, 1980	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lithium CitrateEQ 300MG CARBONATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · syrup;oral	Lithium Citrate	DiscontinuedReference drug

All 27 submissions, including labeling and manufacturing supplements


Oct 13, 2022	Supplement 35Labeling · Standard review	Approved	Label Medication Guide Letter
Feb 5, 2020	Supplement 33Labeling	Approved	Letter Label
Dec 20, 2018	Supplement 32Labeling · Standard review	Approved	Letter Label
Oct 4, 2018	Supplement 31Labeling · Standard review	Approved	Label Letter
Oct 25, 2016	Supplement 25Labeling · Standard review	Approved	Label Letter
Jun 12, 2015	Supplement 29Manufacturing · Standard review	Approved	None posted
Jul 1, 2014	Supplement 28Manufacturing · Standard review	Approved	None posted
Oct 20, 2011	Supplement 27Labeling	Approved	Letter Label
Jan 31, 2003	Supplement 21Labeling · Standard review	Approved	Letter
Nov 8, 2002	Supplement 22Manufacturing · Standard review	Approved	None posted
Nov 26, 2001	Supplement 16Labeling · Standard review	Approved	Letter
Nov 26, 2001	Supplement 15Labeling · Standard review	Approved	Letter
Nov 26, 2001	Supplement 14Labeling	Approved	Letter
Aug 6, 1999	Supplement 20Manufacturing · Standard review	Approved	None posted
Jul 29, 1999	Supplement 19Manufacturing · Standard review	Approved	None posted
Jun 16, 1997	Supplement 18Manufacturing · Standard review	Approved	None posted
Jun 16, 1997	Supplement 17Manufacturing · Standard review	Approved	None posted
Nov 26, 1989	Supplement 13Labeling	Approved	Letter
Jun 28, 1988	Supplement 12Manufacturing · Standard review	Approved	None posted
Nov 26, 1987	Supplement 11Labeling	Approved	Letter
Sep 29, 1987	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 23, 1984	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 24, 1983	Supplement 6Labeling	Approved	None posted
Jan 31, 1983	Supplement 4Labeling	Approved	None posted
Apr 29, 1982	Supplement 2Manufacturing · Standard review	Approved	None posted
May 4, 1981	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 23, 1980	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18421
Drugs@FDA: Overview at FDA
Company: Hikma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters