← FDA DRUG APPROVALS

FDA NDA · NDA018152

ESKALITH CR

Sponsor: JDS PHARMS

APPLICATION
NDA018152
TYPE
NDA
ORIGINAL APPROVAL
1982-03-29
LATEST ACTION
2004-03-11
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

ESKALITH CRDiscontinued
LITHIUM CARBONATE 450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2004-03-11Labeling · Supplement 20 · standard — Letter ↗AP
2002-10-15Manufacturing (CMC) · Supplement 18 · standardAP
2002-08-05Labeling · Supplement 17 · standard — Letter ↗AP
2002-05-08Labeling · Supplement 16 · standard — Letter ↗AP
2002-05-08Labeling · Supplement 12 · standard — Letter ↗AP
2002-05-08Labeling · Supplement 3 — Letter ↗AP
2002-05-08Labeling · Supplement 10 — Letter ↗AP
2002-05-08Labeling · Supplement 8 — Letter ↗AP
2002-05-08Labeling · Supplement 13 · standard — Letter ↗AP
2000-09-21Manufacturing (CMC) · Supplement 14 · standardAP
2000-04-06Manufacturing (CMC) · Supplement 15 · standardAP
1995-10-20Manufacturing (CMC) · Supplement 11 · standardAP
1983-01-27Labeling · Supplement 2AP
1982-04-29Labeling · Supplement 1AP
1982-03-29Type 5 - New Formulation or New Manufacturer · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →