Lithium Carbonate

ANDA 78715, held by Hikma. Lithium Carbonate.

As of Nov 15, 2026, ANDA 78715 (Lithium Carbonate), held by Hikma, was first approved by FDA on Dec 28, 2010, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 28, 2010
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 28, 2010	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lithium Carbonate300MG · tablet;oral	Lithium Carbonate	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Mar 6, 2012	Supplement 3Labeling	Approved	None posted
Dec 28, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 78715
Drugs@FDA: Overview at FDA
Company: Hikma

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