APPLICATION
ANDA071149
TYPE
ANDA
ORIGINAL APPROVAL
1987-03-18
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
INDOMETHACINDiscontinued
INDOMETHACIN 50MG · CAPSULE · ORAL
Approval history
2024-11-21Labeling · Supplement 21 · standardAP
2021-04-28Labeling · Supplement 20 · standardAP
2021-04-17Labeling · Supplement 19 · standardAP
2016-05-09Labeling · Supplement 18 · standardAP
2002-08-13Labeling · Supplement 15AP
2001-05-29Manufacturing (CMC) · Supplement 14AP
2000-07-07Manufacturing (CMC) · Supplement 13AP
1996-07-02Labeling · Supplement 12AP
1996-04-29Labeling · Supplement 11AP
1994-07-15Labeling · Supplement 10AP
1994-05-11Manufacturing (CMC) · Supplement 8AP
1992-11-23Manufacturing (CMC) · Supplement 1AP
1991-11-08Labeling · Supplement 7AP
1991-04-01Labeling · Supplement 6AP
1989-02-24Labeling · Supplement 5AP
1989-02-08Labeling · Supplement 4AP
1987-03-18OriginalAP
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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