Lithium Carbonate

ANDA 78763, held by Pharmobedient. Lithium Carbonate.

As of Nov 15, 2026, ANDA 78763 (Lithium Carbonate), held by Pharmobedient, was first approved by FDA on Apr 15, 2008, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 15, 2008
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
Apr 15, 2008	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lithium Carbonate600MG · capsule;oral	Lithium Carbonate	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Oct 6, 2025	Supplement 10Labeling · Standard review	Approved	None posted
May 3, 2018	Supplement 9Labeling · Standard review	Approved	None posted
Mar 24, 2016	Supplement 5Labeling · Standard review	Approved	None posted
Mar 6, 2012	Supplement 2Labeling	Approved	None posted
Apr 15, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78763
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