APPLICATION
ANDA076691
TYPE
ANDA
ORIGINAL APPROVAL
2004-01-05
LATEST ACTION
2022-10-13
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
LITHIUM CARBONATEPrescription
LITHIUM CARBONATE 450MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2022-10-13Labeling · Supplement 12 · standardAP
2020-02-05Labeling · Supplement 10 · standardAP
2018-12-20Labeling · Supplement 9 · standardAP
2018-12-07Labeling · Supplement 8 · standardAP
2012-01-27Labeling · Supplement 6AP
2004-01-05OriginalAP
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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