APPLICATION
ANDA070673
TYPE
ANDA
ORIGINAL APPROVAL
1987-04-29
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
INDOMETHACINPrescription
INDOMETHACIN 25MG · CAPSULE · ORAL
Approval history
2024-11-21Labeling · Supplement 24 · standardAP
2024-04-11Labeling · Supplement 23 · standardAP
2021-04-28Labeling · Supplement 22 · standardAP
2019-11-12Labeling · Supplement 20 · standardAP
2019-11-12Labeling · Supplement 21 · standardAP
2007-04-15Labeling · Supplement 10AP
1996-07-01Labeling · Supplement 8AP
1996-04-29Labeling · Supplement 7AP
1995-05-23Manufacturing (CMC) · Supplement 5AP
1995-02-01Manufacturing (CMC) · Supplement 6AP
1990-09-10Labeling · Supplement 4AP
1989-10-24Labeling · Supplement 3AP
1989-02-02Labeling · Supplement 2AP
1988-03-03Manufacturing (CMC) · Supplement 1AP
1987-04-29OriginalAP
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.