APPLICATION
ANDA072410
TYPE
ANDA
ORIGINAL APPROVAL
1989-03-15
LATEST ACTION
1998-04-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
INDOMETHACINDiscontinued
INDOMETHACIN 75MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
1998-04-15Manufacturing (CMC) · Supplement 12AP
1995-11-28Manufacturing (CMC) · Supplement 11AP
1995-07-28Manufacturing (CMC) · Supplement 2AP
1993-08-05Labeling · Supplement 8AP
1993-04-02Labeling · Supplement 7AP
1992-12-09Labeling · Supplement 6AP
1992-11-09Manufacturing (CMC) · Supplement 5AP
1992-04-17Labeling · Supplement 4AP
1991-04-15Manufacturing (CMC) · Supplement 1AP
1989-03-15OriginalAP
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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