APPLICATION
ANDA205663
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-05
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 9 · standardAP
2020-02-28Labeling · Supplement 5 · standardAP
2018-12-20Labeling · Supplement 2 · standardAP
2018-12-07Labeling · Supplement 1 · standardAP
2017-06-05UNKNOWN · 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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