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FDA NDA · NDA018558

LITHIUM CARBONATE

Sponsor: HIKMA

APPLICATION
NDA018558
TYPE
NDA
ORIGINAL APPROVAL
1982-01-29
LATEST ACTION
2022-10-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LITHIUM CARBONATE · ReferencePrescription
LITHIUM CARBONATE 300MG · TABLET · ORAL

Approval history

2022-10-13Labeling · Supplement 30 · standard — Letter ↗AP
2022-10-13Labeling · Supplement 29 · standardAP
2020-02-05Labeling · Supplement 28 · 901 required — Letter ↗AP
2018-12-20Labeling · Supplement 27 · standard — Letter ↗AP
2018-10-04Labeling · Supplement 26 · standard — Letter ↗AP
2016-10-25Labeling · Supplement 21 · standard — Letter ↗AP
2016-05-06Manufacturing (CMC) · Supplement 24AP
2011-12-06Labeling · Supplement 22AP
2007-10-31Labeling · Supplement 19AP
2003-02-10Labeling · Supplement 17AP
2000-01-06Manufacturing (CMC) · Supplement 13AP
2000-01-06Manufacturing (CMC) · Supplement 11AP
2000-01-06Manufacturing (CMC) · Supplement 14AP
2000-01-06Manufacturing (CMC) · Supplement 12AP
1996-10-02Manufacturing (CMC) · Supplement 10AP
1996-08-28Manufacturing (CMC) · Supplement 9AP
1995-02-02Labeling · Supplement 7AP
1982-01-29OriginalAP
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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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