APPLICATION
ANDA070756
TYPE
ANDA
ORIGINAL APPROVAL
1986-02-12
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 34 · standardAP
2021-04-28Labeling · Supplement 33 · standardAP
2021-04-23Labeling · Supplement 32 · standardAP
2016-05-09Labeling · Supplement 31 · standardAP
2008-01-28Labeling · Supplement 28AP
2006-11-21Labeling · Supplement 23AP
2002-07-29Manufacturing (CMC) · Supplement 18AP
2001-09-12Manufacturing (CMC) · Supplement 17AP
2000-07-25Labeling · Supplement 16AP
2000-07-25Manufacturing (CMC) · Supplement 15AP
2000-02-02Manufacturing (CMC) · Supplement 13AP
2000-01-28Manufacturing (CMC) · Supplement 14AP
1998-11-05Manufacturing (CMC) · Supplement 12AP
1997-05-30Manufacturing (CMC) · Supplement 11AP
1995-12-01Manufacturing (CMC) · Supplement 10AP
1995-12-01Manufacturing (CMC) · Supplement 9AP
1994-11-01Manufacturing (CMC) · Supplement 8AP
1991-12-18Labeling · Supplement 7AP
1990-12-18Labeling · Supplement 6AP
1990-12-18Manufacturing (CMC) · Supplement 4AP
1990-12-18Manufacturing (CMC) · Supplement 5AP
1990-12-18Manufacturing (CMC) · Supplement 3AP
1989-08-30Labeling · Supplement 2AP
1987-05-13Labeling · Supplement 1AP
1986-02-12OriginalAP
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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