Lithium Carbonate

Treats bipolar I disorder. NDA 18558, held by Hikma. Lithium Carbonate.

As of Nov 13, 2026, NDA 18558 (Lithium Carbonate), held by Hikma, was first approved by FDA on Jan 29, 1982, with 17 approved supplements and 0 published complete response letters.

First approved: Jan 29, 1982
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder:

Treatment of acute manic and mixed episodes in patients 7 years and older
Maintenance treatment in patients 7 years and older

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Jan 29, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lithium Carbonate300MG · tablet;oral	Lithium Carbonate	RxReference drug

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 13, 2022	Supplement 30Labeling · Standard review	Approved	Label Medication Guide Letter
Oct 13, 2022	Supplement 29Labeling · Standard review	Approved	None posted
Feb 5, 2020	Supplement 28Labeling	Approved	Letter Label
Dec 20, 2018	Supplement 27Labeling · Standard review	Approved	Letter Label
Oct 4, 2018	Supplement 26Labeling · Standard review	Approved	Label Letter
Oct 25, 2016	Supplement 21Labeling · Standard review	Approved	Label Letter
May 6, 2016	Supplement 24Manufacturing	Approved	None posted
Dec 6, 2011	Supplement 22Labeling	Approved	None posted
Oct 31, 2007	Supplement 19Labeling	Approved	None posted
Feb 10, 2003	Supplement 17Labeling	Approved	None posted
Jan 6, 2000	Supplement 14Manufacturing	Approved	None posted
Jan 6, 2000	Supplement 13Manufacturing	Approved	None posted
Jan 6, 2000	Supplement 12Manufacturing	Approved	None posted
Jan 6, 2000	Supplement 11Manufacturing	Approved	None posted
Oct 2, 1996	Supplement 10Manufacturing	Approved	None posted
Aug 28, 1996	Supplement 9Manufacturing	Approved	None posted
Feb 2, 1995	Supplement 7Labeling	Approved	None posted
Jan 29, 1982	Original application	Approved	None posted

Identifiers

Application: NDA 18558
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