Eskalith Cr

NDA 18152, held by Jds Pharms. Lithium Carbonate.

As of Nov 13, 2026, NDA 18152 (Eskalith Cr), held by Jds Pharms, was first approved by FDA on Mar 29, 1982, with 14 approved supplements and 0 published complete response letters.

First approved: Mar 29, 1982
Review: Standard
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Mar 29, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Eskalith Cr450MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Lithium Carbonate	Discontinued

All 15 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 11, 2004	Supplement 20Labeling · Standard review	Approved	Label Letter
Oct 15, 2002	Supplement 18Manufacturing · Standard review	Approved	None posted
Aug 5, 2002	Supplement 17Labeling · Standard review	Approved	Letter
May 8, 2002	Supplement 3Labeling	Approved	Letter
May 8, 2002	Supplement 8Labeling	Approved	Letter
May 8, 2002	Supplement 10Labeling	Approved	Letter
May 8, 2002	Supplement 12Labeling · Standard review	Approved	Letter
May 8, 2002	Supplement 13Labeling · Standard review	Approved	Letter
May 8, 2002	Supplement 16Labeling · Standard review	Approved	Letter
Sep 21, 2000	Supplement 14Manufacturing · Standard review	Approved	None posted
Apr 6, 2000	Supplement 15Manufacturing · Standard review	Approved	None posted
Oct 20, 1995	Supplement 11Manufacturing · Standard review	Approved	None posted
Jan 27, 1983	Supplement 2Labeling	Approved	None posted
Apr 29, 1982	Supplement 1Labeling	Approved	None posted
Mar 29, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18152
Drugs@FDA: Overview at FDA
Company: JDS Pharmaceuticals

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