APPLICATION
ANDA076832
TYPE
ANDA
ORIGINAL APPROVAL
2004-10-28
LATEST ACTION
2026-07-13
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
LITHIUM CARBONATEPrescription
LITHIUM CARBONATE 300MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-07-13Labeling · Supplement 15 · standardAP
2020-02-14Labeling · Supplement 13 · standardAP
2020-02-14Labeling · Supplement 11 · standardAP
2020-02-14Labeling · Supplement 12 · standardAP
2012-03-06Labeling · Supplement 9AP
2007-12-26Labeling · Supplement 5AP
2007-09-28Labeling · Supplement 3AP
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.
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