APPLICATION
ANDA202240
TYPE
ANDA
ORIGINAL APPROVAL
2014-10-29
LATEST ACTION
2025-10-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
CELECOXIBPrescription
CELECOXIB 200MG · CAPSULE · ORAL
CELECOXIBPrescription
CELECOXIB 50MG · CAPSULE · ORAL
CELECOXIBPrescription
CELECOXIB 400MG · CAPSULE · ORAL
CELECOXIBPrescription
CELECOXIB 100MG · CAPSULE · ORAL
Approval history
2025-10-21Labeling · Supplement 16 · standardAP
2022-01-05Labeling · Supplement 11 · standardAP
2019-10-09Manufacturing (CMC) · Supplement 7 · unknownAP
2019-10-09Labeling · Supplement 8 · standardAP
2019-10-09Labeling · Supplement 4 · standardAP
2016-09-16Labeling · Supplement 1 · standardAP
2015-06-09OriginalAP
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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