APPLICATION
NDA016860
TYPE
NDA
ORIGINAL APPROVAL
1970-04-06
LATEST ACTION
2004-03-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
ESKALITHDiscontinued
LITHIUM CARBONATE 300MG · CAPSULE · ORAL
Approval history
2000-04-06Manufacturing (CMC) · Supplement 71 · standardAP
2000-02-01Manufacturing (CMC) · Supplement 70 · standardAP
1994-08-30Manufacturing (CMC) · Supplement 66 · standardAP
1984-11-30Manufacturing (CMC) · Supplement 60 · standardAP
1983-01-27Labeling · Supplement 57AP
1982-11-18Manufacturing (CMC) · Supplement 56 · standardAP
1982-04-29Labeling · Supplement 55AP
1981-12-02Labeling · Supplement 54AP
1981-09-11Labeling · Supplement 53AP
1980-09-19Labeling · Supplement 51AP
1980-04-16Manufacturing (CMC) · Supplement 50 · standardAP
1980-02-06Labeling · Supplement 49AP
1980-02-06Labeling · Supplement 48AP
1979-09-27Labeling · Supplement 47AP
1979-09-27Labeling · Supplement 46AP
1979-04-24Labeling · Supplement 45AP
1978-01-25Labeling · Supplement 40AP
1977-10-04Labeling · Supplement 39AP
1975-08-29Manufacturing (CMC) · Supplement 32 · standardAP
1975-08-29Manufacturing (CMC) · Supplement 30 · standardAP
1975-08-29Manufacturing (CMC) · Supplement 31 · standardAP
1975-07-01Labeling · Supplement 29AP
1974-08-23REMS · Supplement 8 · standardAP
1974-06-17Labeling · Supplement 10AP
1970-04-06Type 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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