APPLICATION
ANDA202706
TYPE
ANDA
ORIGINAL APPROVAL
2015-10-05
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
INDOMETHACINDiscontinued
INDOMETHACIN 75MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2024-11-21Labeling · Supplement 13 · standardAP
2021-04-28Labeling · Supplement 9 · standardAP
2021-04-19Labeling · Supplement 4 · standardAP
2016-06-09Labeling · Supplement 1 · standardAP
2015-10-05UNKNOWN · OriginalAP
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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