APPLICATION
ANDA079139
TYPE
ANDA
ORIGINAL APPROVAL
2009-02-03
LATEST ACTION
2023-05-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
LITHIUM CARBONATEPrescription
LITHIUM CARBONATE 600MG · CAPSULE · ORAL
LITHIUM CARBONATEPrescription
LITHIUM CARBONATE 150MG · CAPSULE · ORAL
LITHIUM CARBONATEPrescription
LITHIUM CARBONATE 300MG · CAPSULE · ORAL
Approval history
2023-05-08Labeling · Supplement 12 · standardAP
2020-09-11Labeling · Supplement 8 · standardAP
2020-09-11Labeling · Supplement 9 · standardAP
2018-05-03Labeling · Supplement 6 · standardAP
2015-03-03Labeling · Supplement 2AP
2012-07-25Manufacturing (CMC) · Supplement 5AP
2012-03-06Labeling · Supplement 4AP
2010-09-07Manufacturing (CMC) · Supplement 3AP
2009-02-03OriginalAP
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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