APPLICATION
ANDA070900
TYPE
ANDA
ORIGINAL APPROVAL
1987-02-09
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
INDOMETHACINDiscontinued
INDOMETHACIN 25MG · CAPSULE · ORAL
INDOMETHACINDiscontinued
INDOMETHACIN 50MG · CAPSULE · ORAL
Approval history
2024-11-21Labeling · Supplement 25 · standardAP
2021-04-30Labeling · Supplement 24 · standardAP
2021-04-13Labeling · Supplement 23 · standardAP
2016-05-09Labeling · Supplement 22 · standardAP
2006-09-27Labeling · Supplement 21AP
2002-09-10Labeling · Supplement 12AP
2000-05-16Manufacturing (CMC) · Supplement 11AP
2000-05-16Manufacturing (CMC) · Supplement 10AP
1997-12-05Manufacturing (CMC) · Supplement 9AP
1997-02-24Manufacturing (CMC) · Supplement 8AP
1996-10-17Labeling · Supplement 7AP
1996-08-13Manufacturing (CMC) · Supplement 6AP
1996-04-29Labeling · Supplement 5AP
1994-02-02Manufacturing (CMC) · Supplement 3AP
1994-01-12Manufacturing (CMC) · Supplement 4AP
1989-10-12Labeling · Supplement 2AP
1988-02-24Labeling · Supplement 1AP
1987-02-09OriginalAP
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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