APPLICATION
ANDA091240
TYPE
ANDA
ORIGINAL APPROVAL
2011-04-12
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
INDOMETHACINPrescription
INDOMETHACIN 25MG · CAPSULE · ORAL
INDOMETHACINPrescription
INDOMETHACIN 50MG · CAPSULE · ORAL
Approval history
2024-11-21Labeling · Supplement 13 · standardAP
2021-04-28Labeling · Supplement 9 · standardAP
2021-04-26Labeling · Supplement 3 · standardAP
2016-05-09Labeling · Supplement 1 · standardAP
2011-04-12OriginalAP
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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