APPLICATION
NDA018858
TYPE
NDA
ORIGINAL APPROVAL
1984-04-20
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
INDOMETHACINDiscontinued
INDOMETHACIN 25MG · CAPSULE · ORAL
INDOMETHACINDiscontinued
INDOMETHACIN 50MG · CAPSULE · ORAL
Approval history
2016-07-19Manufacturing (CMC) · Supplement 43AP
2008-04-28Labeling · Supplement 38AP
2006-06-07Labeling · Supplement 32AP
2002-09-26Manufacturing (CMC) · Supplement 28AP
2002-08-22Labeling · Supplement 27AP
1998-02-25Manufacturing (CMC) · Supplement 26AP
1998-02-05Manufacturing (CMC) · Supplement 25AP
1996-04-18Labeling · Supplement 24AP
1994-05-02Manufacturing (CMC) · Supplement 22AP
1993-10-05Labeling · Supplement 23AP
1993-04-20Labeling · Supplement 20AP
1992-12-10Labeling · Supplement 19AP
1990-01-31Manufacturing (CMC) · Supplement 18AP
1989-11-20Labeling · Supplement 17AP
1989-06-22Labeling · Supplement 16AP
1989-04-26Labeling · Supplement 15AP
1988-04-12Labeling · Supplement 14AP
1987-09-24Manufacturing (CMC) · Supplement 13AP
1985-07-31Manufacturing (CMC) · Supplement 8AP
1985-07-31Manufacturing (CMC) · Supplement 6AP
1985-07-31Manufacturing (CMC) · Supplement 4AP
1985-07-31Manufacturing (CMC) · Supplement 7AP
1985-07-31Manufacturing (CMC) · Supplement 5AP
1985-07-31Manufacturing (CMC) · Supplement 1AP
1985-03-20Manufacturing (CMC) · Supplement 3AP
1984-04-20OriginalAP
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.