Lithium Carbonate

Treats bipolar I disorder. NDA 17812, held by Hikma. Lithium Carbonate.

As of Nov 13, 2026, NDA 17812 (Lithium Carbonate), held by Hikma, was first approved by FDA on Nov 26, 1980, with 29 approved supplements and 0 published complete response letters.

First approved: Nov 26, 1980
Review: Standard
Supplements approved: 29
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 30 submissions below

Date	Submission	Status	Documents
Nov 26, 1980	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

3 strengths and forms


Lithium Carbonate300MG · capsule;oral	Lithium Carbonate	RxReference drug
Lithium Carbonate150MG · capsule;oral	Lithium Carbonate	RxReference drug
Lithium Carbonate600MG · capsule;oral	Lithium Carbonate	RxReference drug

All 30 submissions, including labeling and manufacturing supplements


Oct 13, 2022	Supplement 36Labeling · Standard review	Approved	Label Medication Guide Letter
Feb 5, 2020	Supplement 34Labeling	Approved	Letter Label
Dec 20, 2018	Supplement 33Labeling · Standard review	Approved	Letter Label
Oct 4, 2018	Supplement 31Labeling · Standard review	Approved	Label Letter
Oct 25, 2016	Supplement 27Labeling · Standard review	Approved	Label Letter
Feb 26, 2016	Supplement 30Manufacturing · Standard review	Approved	None posted
Oct 20, 2011	Supplement 28Labeling	Approved	Letter Label
Oct 5, 2007	Supplement 25Labeling · Standard review	Approved	None posted
Jan 31, 2003	Supplement 23Labeling · Standard review	Approved	Letter
Nov 26, 2001	Supplement 17Labeling · Standard review	Approved	Letter
Nov 26, 2001	Supplement 16Labeling · Standard review	Approved	Letter
Nov 26, 2001	Supplement 14Labeling	Approved	Letter
Nov 26, 2001	Supplement 13Labeling	Approved	Letter
Nov 26, 2001	Supplement 11Labeling	Approved	Letter
Nov 21, 2001	Supplement 22Manufacturing · Standard review	Approved	None posted
Jun 14, 2001	Supplement 21Manufacturing · Standard review	Approved	Letter
Dec 6, 2000	Supplement 20Manufacturing · Standard review	Approved	None posted
Aug 17, 2000	Supplement 19Manufacturing · Standard review	Approved	None posted
Jun 3, 1998	Supplement 18Manufacturing · Standard review	Approved	None posted
Aug 1, 1994	Supplement 15Manufacturing · Standard review	Approved	None posted
Feb 10, 1988	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 29, 1987	Supplement 9Manufacturing · Standard review	Approved	None posted
Jan 28, 1987	Supplement 7Labeling	Approved	None posted
Jan 28, 1987	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 28, 1987	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 14, 1983	Supplement 4Labeling	Approved	None posted
Jan 31, 1983	Supplement 3Labeling	Approved	None posted
Sep 9, 1982	Supplement 1Labeling	Approved	None posted
Jan 6, 1982	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 26, 1980	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17812
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