APPLICATION
ANDA208701
TYPE
ANDA
ORIGINAL APPROVAL
2019-11-14
LATEST ACTION
2025-01-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
CELECOXIBPrescription
CELECOXIB 50MG · CAPSULE · ORAL
CELECOXIBPrescription
CELECOXIB 400MG · CAPSULE · ORAL
CELECOXIBPrescription
CELECOXIB 100MG · CAPSULE · ORAL
CELECOXIBPrescription
CELECOXIB 200MG · CAPSULE · ORAL
Approval history
2025-01-15Labeling · Supplement 3 · standardAP
2022-01-05Labeling · Supplement 1 · standardAP
2019-11-14UNKNOWN · Original · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.