← FDA DRUG APPROVALS

FDA NDA · NDA016782

LITHONATE

Sponsor: SOLVAY

APPLICATION
NDA016782
TYPE
NDA
ORIGINAL APPROVAL
1970-04-06
LATEST ACTION
1994-06-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

LITHONATEDiscontinued
LITHIUM CARBONATE 300MG · CAPSULE · ORAL

Approval history

1994-06-28Manufacturing (CMC) · Supplement 35 · priorityAP
1993-10-06Manufacturing (CMC) · Supplement 39 · priorityAP
1992-07-16Manufacturing (CMC) · Supplement 37 · priorityAP
1990-04-11Manufacturing (CMC) · Supplement 34 · priorityAP
1988-11-18Manufacturing (CMC) · Supplement 32 · priorityAP
1988-11-18Labeling · Supplement 30 · priorityAP
1988-11-18Manufacturing (CMC) · Supplement 31 · priorityAP
1984-12-19Manufacturing (CMC) · Supplement 28 · priorityAP
1984-12-19Manufacturing (CMC) · Supplement 26 · priorityAP
1984-12-19Labeling · Supplement 27 · priorityAP
1982-07-23Manufacturing (CMC) · Supplement 23 · priorityAP
1982-07-23Manufacturing (CMC) · Supplement 22 · priorityAP
1982-02-04Labeling · Supplement 25 · priorityAP
1980-10-02Labeling · Supplement 21 · priorityAP
1979-02-22Manufacturing (CMC) · Supplement 19 · priorityAP
1979-01-23Labeling · Supplement 18 · priorityAP
1978-01-26Manufacturing (CMC) · Supplement 17 · priorityAP
1977-08-01Labeling · Supplement 16 · priorityAP
1976-06-03Manufacturing (CMC) · Supplement 15 · priorityAP
1976-04-02Manufacturing (CMC) · Supplement 14 · priorityAP
1975-07-01Manufacturing (CMC) · Supplement 12 · priorityAP
1970-04-06Type 1 - New Molecular Entity · Original · priorityAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →