Lithium Carbonate

ANDA 202219, held by Pharmobedient. Lithium Carbonate.

As of Nov 15, 2026, ANDA 202219 (Lithium Carbonate), held by Pharmobedient, was first approved by FDA on Aug 8, 2012, with 4 approved supplements and 0 published complete response letters.

First approved: Aug 8, 2012
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Aug 8, 2012	Original application	Approved	None posted

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


Oct 13, 2022	Supplement 9Labeling · Standard review	Approved	None posted
Feb 5, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Dec 20, 2018	Supplement 3Labeling · Standard review	Approved	None posted
Dec 6, 2018	Supplement 2Labeling · Standard review	Approved	None posted
Aug 8, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 202219
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