Lithium Carbonate

NDA 16834, held by Pfizer. Lithium Carbonate.

As of Nov 13, 2026, NDA 16834 (Lithium Carbonate), held by Pfizer, was first approved by FDA on Apr 6, 1970, with 5 approved supplements and 0 published complete response letters.

First approved: Apr 6, 1970
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Apr 6, 1970	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 27, 1980	Supplement 12Labeling	Approved	None posted
Dec 20, 1978	Supplement 11Labeling	Approved	None posted
Nov 11, 1977	Supplement 8Labeling	Approved	None posted
Jul 23, 1976	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 24, 1974	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 6, 1970	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 16834
Drugs@FDA: Overview at FDA
Company: Pfizer

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