Lithium Carbonate

Treats bipolar I disorder. ANDA 90702, held by Hetero Labs Ltd Iii. Lithium Carbonate.

As of Nov 15, 2026, ANDA 90702 (Lithium Carbonate), held by Hetero Labs Ltd Iii, was first approved by FDA on Sep 25, 2009, with 4 approved supplements and 0 published complete response letters.

First approved: Sep 25, 2009
Supplements approved: 4
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 5 submissions below

Date	Submission	Status	Documents
Sep 25, 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 5 submissions, including labeling and manufacturing supplements


Oct 1, 2021	Supplement 10Labeling · Standard review	Approved	None posted
Oct 1, 2021	Supplement 7Labeling · Standard review	Approved	None posted
May 3, 2018	Supplement 4Labeling · Standard review	Approved	None posted
Mar 6, 2012	Supplement 2Labeling	Approved	None posted
Sep 25, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 90702
Drugs@FDA: Overview at FDA
Company: Hetero Labs Ltd Iii

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