APPLICATION
ANDA071342
TYPE
ANDA
ORIGINAL APPROVAL
1988-04-18
LATEST ACTION
1998-03-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
INDOMETHACINDiscontinued
INDOMETHACIN 25MG · CAPSULE · ORAL
Approval history
1998-03-17Manufacturing (CMC) · Supplement 15AP
1996-03-22Manufacturing (CMC) · Supplement 14AP
1994-08-02Manufacturing (CMC) · Supplement 12AP
1994-07-18Manufacturing (CMC) · Supplement 13AP
1994-03-31Manufacturing (CMC) · Supplement 11AP
1992-11-17Manufacturing (CMC) · Supplement 9AP
1992-05-12Manufacturing (CMC) · Supplement 7AP
1991-12-31Labeling · Supplement 8AP
1991-07-15Manufacturing (CMC) · Supplement 6AP
1989-07-13Manufacturing (CMC) · Supplement 1AP
1989-07-13Manufacturing (CMC) · Supplement 4AP
1989-07-13Labeling · Supplement 2AP
1989-07-13Manufacturing (CMC) · Supplement 3AP
1989-02-16Labeling · Supplement 5AP
1988-04-18OriginalAP
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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