Lithium Carbonate

ANDA 76366, held by Heritage Pharma. Lithium Carbonate.

As of Nov 15, 2026, ANDA 76366 (Lithium Carbonate), held by Heritage Pharma, was first approved by FDA on Aug 21, 2003, with 5 approved supplements and 0 published complete response letters.

First approved: Aug 21, 2003
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Aug 21, 2003	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lithium Carbonate450MG · tablet, extended release;oral	Lithium Carbonate	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Oct 13, 2022	Supplement 8Labeling · Standard review	Approved	None posted
Feb 5, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Dec 20, 2018	Supplement 6Labeling · Standard review	Approved	None posted
Dec 7, 2018	Supplement 5Labeling · Standard review	Approved	None posted
Oct 20, 2003	Supplement 3Labeling	Approved	None posted
Aug 21, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 76366
Drugs@FDA: Overview at FDA
Company: Heritage 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