APPLICATION
ANDA091544
TYPE
ANDA
ORIGINAL APPROVAL
2010-12-27
LATEST ACTION
2023-08-25
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
LITHIUM CARBONATEPrescription
LITHIUM CARBONATE 300MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2023-08-25Labeling · Supplement 12 · standardAP
2020-09-09Labeling · Supplement 9 · standardAP
2020-09-09Labeling · Supplement 7 · standardAP
2020-09-09Labeling · Supplement 8 · standardAP
2020-09-09Labeling · Supplement 6 · standardAP
2020-09-09Labeling · Supplement 4 · standardAP
2012-03-06Labeling · Supplement 2AP
2010-12-27OriginalAP
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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