APPLICATION
ANDA202219
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-08
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 9 · standardAP
2020-02-05Labeling · Supplement 4 · standardAP
2018-12-20Labeling · Supplement 3 · standardAP
2018-12-06Labeling · Supplement 2 · standardAP
2012-08-08UNKNOWN · OriginalAP
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.