APPLICATION
ANDA204590
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-16
LATEST ACTION
2025-04-07
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
2025-04-07Labeling · Supplement 10 · standardAP
2025-04-07Labeling · Supplement 37 · standardAP
2025-04-07Labeling · Supplement 19 · standardAP
2025-04-07Labeling · Supplement 23 · standardAP
2025-04-07Labeling · Supplement 13 · standardAP
2025-04-07Labeling · Supplement 9 · standardAP
2023-06-07Labeling · Supplement 21 · standardAP
2016-09-16Labeling · Supplement 3 · standardAP
2016-03-16UNKNOWN · 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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