Lithium Carbonate

Treats bipolar I disorder. ANDA 79159, held by Alembic Ltd. Lithium Carbonate.

As of Nov 15, 2026, ANDA 79159 (Lithium Carbonate), held by Alembic Ltd, was first approved by FDA on Jan 12, 2009, with 5 approved supplements and 0 published complete response letters.

First approved: Jan 12, 2009
Supplements approved: 5
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 6 submissions below

Date	Submission	Status	Documents
Jan 12, 2009	Original application	Approved	None posted

Products

3 strengths and forms


Lithium Carbonate150MG · capsule;oral	Lithium Carbonate	Rx
Lithium Carbonate300MG · capsule;oral	Lithium Carbonate	Rx
Lithium Carbonate600MG · capsule;oral	Lithium Carbonate	Rx

All 6 submissions, including labeling and manufacturing supplements


Jan 5, 2023	Supplement 12Labeling · Standard review	Approved	None posted
Sep 11, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Sep 11, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Sep 11, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Mar 6, 2012	Supplement 1Labeling	Approved	None posted
Jan 12, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 79159
Drugs@FDA: Overview at FDA
Company: Alembic, LLC

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