APPLICATION
ANDA079175
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-06
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 21 · standardAP
2021-05-12Labeling · Supplement 13 · standardAP
2016-05-09Labeling · Supplement 7 · standardAP
2009-03-06OriginalAP
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.
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