FDA ANDA · ANDA202139
INDOMETHACIN
Sponsor: MYLAN
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APPLICATION
ANDA202139
TYPE
ANDA
ORIGINAL APPROVAL
2014-03-20
LATEST ACTION
2026-09-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
INDOMETHACINDiscontinued
INDOMETHACIN 75MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2026-09-30Labeling · Supplement 7 · standardAP
2024-11-21Labeling · Supplement 6 · standardAP
2021-04-28Labeling · Supplement 5 · standardAP
2021-04-23Labeling · Supplement 3 · standardAP
2021-04-23Labeling · Supplement 4 · standardAP
2016-05-09Labeling · Supplement 2 · standardAP
2014-03-20Not Applicable · OriginalAP
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