APPLICATION
ANDA075848
TYPE
ANDA
ORIGINAL APPROVAL
2001-02-09
LATEST ACTION
2026-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
OXAPROZINDiscontinued
OXAPROZIN 600MG · TABLET · ORAL
Approval history
2026-01-22Labeling · Supplement 7 · standardAP
2004-07-19Labeling · Supplement 4AP
2002-11-07Manufacturing (CMC) · Supplement 2AP
2002-06-07Manufacturing (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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