APPLICATION
ANDA204519
TYPE
ANDA
ORIGINAL APPROVAL
2015-08-21
LATEST ACTION
2026-07-17
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
2026-07-17Labeling · Supplement 25 · standardAP
2024-07-16Labeling · Supplement 16 · standardAP
2019-09-18Labeling · Supplement 7 · standardAP
2019-09-18Labeling · Supplement 5 · standardAP
2016-09-16Labeling · Supplement 2 · standardAP
2015-08-21UNKNOWN · OriginalAP
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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