APPLICATION
NDA017971
TYPE
NDA
ORIGINAL APPROVAL
1979-02-26
LATEST ACTION
2004-03-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ESKALITHDiscontinued
LITHIUM CARBONATE 300MG · TABLET · ORAL
Approval history
1987-07-29Manufacturing (CMC) · Supplement 10 · standardAP
1983-01-27Labeling · Supplement 9AP
1982-04-29Labeling · Supplement 8AP
1981-12-02Labeling · Supplement 7AP
1981-11-24Labeling · Supplement 6AP
1981-09-11Labeling · Supplement 5AP
1980-09-19Labeling · Supplement 3AP
1980-02-06Labeling · Supplement 2AP
1979-09-20Labeling · Supplement 1AP
1979-02-26Type 5 - New Formulation or New Manufacturer · 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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