Lithium Carbonate

ANDA 76490, held by Hikma Intl Pharms. Lithium Carbonate.

As of Nov 15, 2026, ANDA 76490 (Lithium Carbonate), held by Hikma Intl Pharms, was first approved by FDA on Jun 17, 2003, with 6 approved supplements and 0 published complete response letters.

First approved: Jun 17, 2003
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jun 17, 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 7 submissions, including labeling and manufacturing supplements


Feb 5, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Dec 20, 2018	Supplement 11Labeling · Standard review	Approved	None posted
Dec 6, 2018	Supplement 10Labeling · Standard review	Approved	None posted
Oct 5, 2007	Supplement 3Labeling	Approved	None posted
Jun 19, 2007	Supplement 2Manufacturing	Approved	None posted
Jan 31, 2007	Supplement 1Labeling	Approved	None posted
Jun 17, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 76490
Drugs@FDA: Overview at FDA
Company: Hikma International 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