APPLICATION
ANDA206827
TYPE
ANDA
ORIGINAL APPROVAL
2016-02-01
LATEST ACTION
2024-12-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
CELECOXIBPrescription
CELECOXIB 400MG · CAPSULE · ORAL
CELECOXIBPrescription
CELECOXIB 100MG · CAPSULE · ORAL
CELECOXIBPrescription
CELECOXIB 200MG · CAPSULE · ORAL
CELECOXIBPrescription
CELECOXIB 50MG · CAPSULE · ORAL
Approval history
2024-12-19Labeling · Supplement 13 · standardAP
2022-01-05Labeling · Supplement 9 · standardAP
2019-09-09Labeling · Supplement 6 · standardAP
2019-07-25Labeling · Supplement 4 · standardAP
2016-09-14Labeling · Supplement 2 · 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.
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