Lithium Carbonate

Treats manic episodes of Bipolar Disorder. ANDA 91544, held by Glenmark Pharms. Lithium Carbonate.

As of Nov 15, 2026, ANDA 91544 (Lithium Carbonate), held by Glenmark Pharms, was first approved by FDA on Dec 27, 2010, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 27, 2010
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS Lithium carbonate extended-release tablets are indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-IV) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium carbonate extended-release tablets are also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Dec 27, 2010	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lithium Carbonate300MG · tablet, extended release;oral	Lithium Carbonate	Rx

All 8 submissions, including labeling and manufacturing supplements


Aug 25, 2023	Supplement 12Labeling · Standard review	Approved	None posted
Sep 9, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Sep 9, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Sep 9, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Sep 9, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Sep 9, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Mar 6, 2012	Supplement 2Labeling	Approved	None posted
Dec 27, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 91544
Drugs@FDA: Overview at FDA
Company: Glenmark Pharmaceuticals

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