APPLICATION
ANDA070624
TYPE
ANDA
ORIGINAL APPROVAL
1985-09-04
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
INDOMETHACINDiscontinued
INDOMETHACIN 50MG · CAPSULE · ORAL
Approval history
2024-11-21Labeling · Supplement 41 · standardAP
2021-04-28Labeling · Supplement 39 · standardAP
2021-04-02Labeling · Supplement 38 · standardAP
2021-04-02Labeling · Supplement 35 · standardAP
2016-05-09Labeling · Supplement 33 · standardAP
2008-04-28Labeling · Supplement 29AP
2006-06-27Labeling · Supplement 24AP
2002-09-26Manufacturing (CMC) · Supplement 20AP
2002-08-22Labeling · Supplement 19AP
1998-02-25Manufacturing (CMC) · Supplement 18AP
1998-02-05Manufacturing (CMC) · Supplement 17AP
1996-04-16Labeling · Supplement 16AP
1994-05-02Manufacturing (CMC) · Supplement 14AP
1993-10-05Labeling · Supplement 15AP
1993-04-20Labeling · Supplement 12AP
1992-12-10Labeling · Supplement 11AP
1990-01-31Manufacturing (CMC) · Supplement 10AP
1989-11-20Labeling · Supplement 9AP
1989-06-30Labeling · Supplement 8AP
1989-02-16Labeling · Supplement 7AP
1988-04-14Labeling · Supplement 6AP
1987-09-24Manufacturing (CMC) · Supplement 5AP
1986-08-14Manufacturing (CMC) · Supplement 3AP
1986-06-20Labeling · Supplement 4AP
1986-04-08Labeling · Supplement 2AP
1985-09-04OriginalAP
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.