APPLICATION
ANDA074131
TYPE
ANDA
ORIGINAL APPROVAL
1992-12-11
LATEST ACTION
2025-09-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
PIROXICAMPrescription
PIROXICAM 10MG · CAPSULE · ORAL
PIROXICAMPrescription
PIROXICAM 20MG · CAPSULE · ORAL
Approval history
2025-09-12Labeling · Supplement 32 · standardAP
2023-10-10Labeling · Supplement 31 · standardAP
2022-02-08Labeling · Supplement 28 · standardAP
2019-12-23Labeling · Supplement 24 · standardAP
2019-12-23Labeling · Supplement 22 · standardAP
2019-12-23Labeling · Supplement 20 · standardAP
2010-11-29Labeling · Supplement 18AP
2008-01-08Labeling · Supplement 16AP
2006-04-04Labeling · Supplement 15AP
2006-03-02Labeling · Supplement 14AP
1999-12-02Manufacturing (CMC) · Supplement 12AP
1999-12-02Manufacturing (CMC) · Supplement 11AP
1999-02-12Manufacturing (CMC) · Supplement 4AP
1999-02-12Manufacturing (CMC) · Supplement 3AP
1998-07-13Manufacturing (CMC) · Supplement 2AP
1997-08-11Manufacturing (CMC) · Supplement 1AP
1992-12-11OriginalAP
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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