Lithium Carbonate

ANDA 76243, held by Pharmobedient. Lithium Carbonate.

As of Nov 15, 2026, ANDA 76243 (Lithium Carbonate), held by Pharmobedient, was first approved by FDA on Jun 27, 2002, with 6 approved supplements and 0 published complete response letters.

First approved: Jun 27, 2002
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 27, 2002	Original application	Approved	Review

Products

2 strengths and forms


Lithium Carbonate300MG · capsule;oral	Lithium Carbonate	Discontinued
Lithium Carbonate150MG · capsule;oral	Lithium Carbonate	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Oct 6, 2025	Supplement 16Labeling · Standard review	Approved	None posted
May 3, 2018	Supplement 14Labeling · Standard review	Approved	None posted
Aug 14, 2016	Supplement 11Labeling · Standard review	Approved	None posted
Mar 6, 2012	Supplement 9Labeling	Approved	None posted
Feb 24, 2003	Supplement 1Manufacturing	Approved	None posted
Feb 24, 2003	Supplement 2Labeling	Approved	None posted
Jun 27, 2002	Original application	Approved	Review

Identifiers

Application: ANDA 76243
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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