APPLICATION
NDA018118
TYPE
NDA
ORIGINAL APPROVAL
1982-07-26
LATEST ACTION
1998-10-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
LANOXICAPSDiscontinued
DIGOXIN 0.15MG · CAPSULE · ORAL
LANOXICAPSDiscontinued
DIGOXIN 0.05MG · CAPSULE · ORAL
LANOXICAPSDiscontinued
DIGOXIN 0.1MG · CAPSULE · ORAL
LANOXICAPSDiscontinued
DIGOXIN 0.2MG · CAPSULE · ORAL
Approval history
1998-10-28Manufacturing (CMC) · Supplement 17 · standardAP
1996-06-25Labeling · Supplement 15 · standardAP
1994-05-05Manufacturing (CMC) · Supplement 13 · standardAP
1994-04-28Labeling · Supplement 14 · standardAP
1993-08-06Manufacturing (CMC) · Supplement 12 · standardAP
1992-05-07Labeling · Supplement 11 · standardAP
1989-01-31Labeling · Supplement 10 · standardAP
1987-05-22Labeling · Supplement 9 · standardAP
1986-09-04Manufacturing (CMC) · Supplement 8 · standardAP
1986-08-12Labeling · Supplement 6 · standardAP
1986-08-12Labeling · Supplement 3 · standardAP
1984-09-24Efficacy · Supplement 2 · standardAP
1984-06-18Manufacturing (CMC) · Supplement 7 · standardAP
1984-05-10Manufacturing (CMC) · Supplement 5 · standardAP
1984-01-09Manufacturing (CMC) · Supplement 1 · standardAP
1984-01-05Manufacturing (CMC) · Supplement 4 · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.