APPLICATION
ANDA074464
TYPE
ANDA
ORIGINAL APPROVAL
1998-05-28
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 25 · standardAP
2023-10-16Labeling · Supplement 23 · standardAP
2021-04-28Labeling · Supplement 21 · standardAP
2020-02-02Labeling · Supplement 20 · standardAP
2020-02-02Labeling · Supplement 19 · standardAP
2016-05-09Labeling · Supplement 17 · standardAP
2006-03-13Labeling · Supplement 4AP
2006-03-13Labeling · Supplement 5AP
2000-02-02Manufacturing (CMC) · Supplement 2AP
1999-02-12Manufacturing (CMC) · Supplement 1AP
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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