Eskalith

NDA 16860, held by Noven Therap. Lithium Carbonate.

As of Nov 13, 2026, NDA 16860 (Eskalith), held by Noven Therap, was first approved by FDA on Apr 6, 1970, with 32 approved supplements and 0 published complete response letters.

First approved: Apr 6, 1970
Review: Standard
Supplements approved: 32
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 33 submissions below

Date	Submission	Status	Documents
Apr 6, 1970	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Eskalith300MG · capsule;oral	Lithium Carbonate	Discontinued

All 33 submissions, including labeling and manufacturing supplements


Mar 11, 2004	Supplement 74Labeling · Standard review	Approved	Label Letter
Aug 5, 2002	Supplement 73Labeling · Standard review	Approved	Letter
May 8, 2002	Supplement 67Labeling	Approved	Letter
May 8, 2002	Supplement 68Labeling · Standard review	Approved	Letter
May 8, 2002	Supplement 69Labeling · Standard review	Approved	Letter
May 8, 2002	Supplement 72Labeling · Standard review	Approved	Letter
May 8, 2002	Supplement 59Labeling	Approved	Letter
May 8, 2002	Supplement 65Labeling	Approved	Letter
Apr 6, 2000	Supplement 71Manufacturing · Standard review	Approved	None posted
Feb 1, 2000	Supplement 70Manufacturing · Standard review	Approved	None posted
Aug 30, 1994	Supplement 66Manufacturing · Standard review	Approved	None posted
Nov 30, 1984	Supplement 60Manufacturing · Standard review	Approved	None posted
Jan 27, 1983	Supplement 57Labeling	Approved	None posted
Nov 18, 1982	Supplement 56Manufacturing · Standard review	Approved	None posted
Apr 29, 1982	Supplement 55Labeling	Approved	None posted
Dec 2, 1981	Supplement 54Labeling	Approved	None posted
Sep 11, 1981	Supplement 53Labeling	Approved	None posted
Sep 19, 1980	Supplement 51Labeling	Approved	None posted
Apr 16, 1980	Supplement 50Manufacturing · Standard review	Approved	None posted
Feb 6, 1980	Supplement 48Labeling	Approved	None posted
Feb 6, 1980	Supplement 49Labeling	Approved	None posted
Sep 27, 1979	Supplement 46Labeling	Approved	None posted
Sep 27, 1979	Supplement 47Labeling	Approved	None posted
Apr 24, 1979	Supplement 45Labeling	Approved	None posted
Jan 25, 1978	Supplement 40Labeling	Approved	None posted
Oct 4, 1977	Supplement 39Labeling	Approved	None posted
Aug 29, 1975	Supplement 30Manufacturing · Standard review	Approved	None posted
Aug 29, 1975	Supplement 31Manufacturing · Standard review	Approved	None posted
Aug 29, 1975	Supplement 32Manufacturing · Standard review	Approved	None posted
Jul 1, 1975	Supplement 29Labeling	Approved	None posted
Aug 23, 1974	Supplement 8REMS · Standard review	Approved	None posted
Jun 17, 1974	Supplement 10Labeling	Approved	None posted
Apr 6, 1970	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 16860
Drugs@FDA: Overview at FDA
Company: Noven Therap

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