APPLICATION
ANDA075849
TYPE
ANDA
ORIGINAL APPROVAL
2002-07-03
LATEST ACTION
2025-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
OXAPROZINDiscontinued
OXAPROZIN 600MG · TABLET · ORAL
Approval history
2025-02-28Labeling · Supplement 16 · standardAP
2024-10-17Labeling · Supplement 14 · standardAP
2024-10-17Labeling · Supplement 15 · standardAP
2024-10-17Labeling · Supplement 13 · standardAP
2019-08-27Labeling · Supplement 7 · standardAP
2019-08-27Labeling · Supplement 8 · standardAP
2007-02-09Labeling · Supplement 4AP
2006-06-07Labeling · Supplement 3AP
2006-02-07Labeling · Supplement 2AP
2005-01-04Labeling · Supplement 1AP
2002-07-03OriginalAP
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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