Lithotabs

NDA 16980, held by Solvay. Lithium Carbonate.

As of Nov 13, 2026, NDA 16980 (Lithotabs), held by Solvay, was first approved by FDA on Apr 24, 1972, with 15 approved supplements and 0 published complete response letters.

First approved: Apr 24, 1972
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Apr 24, 1972	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lithotabs300MG · tablet;oral	Lithium Carbonate	Discontinued

All 16 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 28, 1994	Supplement 22Manufacturing · Standard review	Approved	None posted
Mar 25, 1994	Supplement 26Manufacturing · Standard review	Approved	None posted
Mar 25, 1994	Supplement 24Manufacturing · Standard review	Approved	None posted
Apr 13, 1990	Supplement 21Manufacturing · Standard review	Approved	None posted
Apr 11, 1990	Supplement 20Manufacturing · Standard review	Approved	None posted
Dec 19, 1984	Supplement 17Labeling · Standard review	Approved	None posted
Nov 15, 1984	Supplement 16Manufacturing · Standard review	Approved	None posted
Jan 21, 1983	Supplement 15Manufacturing · Standard review	Approved	None posted
Jul 23, 1982	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 4, 1982	Supplement 14Labeling · Standard review	Approved	None posted
Oct 2, 1980	Supplement 11Labeling · Standard review	Approved	None posted
Mar 28, 1980	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 13, 1979	Supplement 8Labeling · Standard review	Approved	None posted
Jan 30, 1978	Supplement 7Labeling · Standard review	Approved	None posted
Mar 19, 1976	Supplement 3Labeling · Standard review	Approved	None posted
Apr 24, 1972	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 16980
Drugs@FDA: Overview at FDA
Company: Solvay

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