APPLICATION
ANDA076114
TYPE
ANDA
ORIGINAL APPROVAL
2002-02-06
LATEST ACTION
2002-11-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
INDOMETHACINDiscontinued
INDOMETHACIN 75MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2002-11-08Labeling · Supplement 4AP
2002-11-08Manufacturing (CMC) · Supplement 2AP
2002-11-08Manufacturing (CMC) · Supplement 5AP
2002-11-08Manufacturing (CMC) · Supplement 3AP
2002-08-19Manufacturing (CMC) · Supplement 1AP
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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