Lithium Carbonate

ANDA 76795, held by Apotex Inc. Lithium Carbonate.

As of Nov 15, 2026, ANDA 76795 (Lithium Carbonate), held by Apotex Inc, was first approved by FDA on Nov 22, 2004, with 6 approved supplements and 0 published complete response letters.

First approved: Nov 22, 2004
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
Nov 22, 2004	Original application	Approved	None posted

Products

1 strengths and forms

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

All 7 submissions, including labeling and manufacturing supplements


May 12, 2023	Supplement 15Labeling · Standard review	Approved	None posted
Sep 11, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Sep 11, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Sep 11, 2020	Supplement 14Labeling · Standard review	Approved	None posted
May 3, 2018	Supplement 10Labeling · Standard review	Approved	None posted
Aug 13, 2012	Supplement 8Labeling · Standard review	Approved	None posted
Nov 22, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 76795
Drugs@FDA: Overview at FDA
Company: Apotex

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