APPLICATION
ANDA204853
TYPE
ANDA
ORIGINAL APPROVAL
2017-05-08
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
INDOMETHACINPrescription
INDOMETHACIN 75MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2024-11-21Labeling · Supplement 3 · standardAP
2021-04-28Labeling · Supplement 2 · standardAP
2017-05-08UNKNOWN · Original · 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.