APPLICATION
ANDA076366
TYPE
ANDA
ORIGINAL APPROVAL
2003-08-21
LATEST ACTION
2022-10-13
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
LITHIUM CARBONATEDiscontinued
LITHIUM CARBONATE 450MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2022-10-13Labeling · Supplement 8 · standardAP
2020-02-05Labeling · Supplement 7 · standardAP
2018-12-20Labeling · Supplement 6 · standardAP
2018-12-07Labeling · Supplement 5 · standardAP
2003-10-20Labeling · Supplement 3AP
2003-08-21OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.