APPLICATION
ANDA205532
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-29
LATEST ACTION
2025-04-21
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
LITHIUM CARBONATEPrescription
LITHIUM CARBONATE 300MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-04-21Labeling · Supplement 9 · standardAP
2025-04-21Labeling · Supplement 14 · standardAP
2020-02-14Labeling · Supplement 3 · standardAP
2020-02-14Labeling · Supplement 1 · standardAP
2019-05-06Manufacturing (CMC) · Supplement 2 · unknownAP
2016-09-29UNKNOWN · Original · standardAP
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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