APPLICATION
ANDA075855
TYPE
ANDA
ORIGINAL APPROVAL
2001-01-31
LATEST ACTION
2025-02-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
OXAPROZINPrescription
OXAPROZIN 600MG · TABLET · ORAL
Approval history
2025-02-18Labeling · Supplement 13 · standardAP
2023-08-17Labeling · Supplement 10 · standardAP
2023-08-17Labeling · Supplement 11 · standardAP
2019-09-11Labeling · Supplement 9 · standardAP
2019-09-11Labeling · Supplement 8 · standardAP
2006-03-31Labeling · Supplement 5AP
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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