APPLICATION
ANDA075845
TYPE
ANDA
ORIGINAL APPROVAL
2001-01-31
LATEST ACTION
2023-09-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
OXAPROZINPrescription
OXAPROZIN 600MG · TABLET · ORAL
Approval history
2023-09-14Labeling · Supplement 28 · standardAP
2023-09-14Labeling · Supplement 26 · standardAP
2019-08-27Labeling · Supplement 22 · standardAP
2019-08-27Labeling · Supplement 20 · standardAP
2012-10-01Labeling · Supplement 13AP
2006-11-29Labeling · Supplement 10AP
2006-02-07Labeling · Supplement 8AP
2005-03-17Labeling · Supplement 6AP
2002-06-13Manufacturing (CMC) · Supplement 1AP
2002-06-13Manufacturing (CMC) · Supplement 2AP
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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