APPLICATION
ANDA076490
TYPE
ANDA
ORIGINAL APPROVAL
2003-06-17
LATEST ACTION
2020-02-05
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
LITHIUM CARBONATEDiscontinued
LITHIUM CARBONATE 450MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2020-02-05Labeling · Supplement 12 · standardAP
2018-12-20Labeling · Supplement 11 · standardAP
2018-12-06Labeling · Supplement 10 · standardAP
2007-10-05Labeling · Supplement 3AP
2007-06-19Manufacturing (CMC) · Supplement 2AP
2007-01-31Labeling · Supplement 1AP
2003-06-17OriginalAP
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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