APPLICATION
ANDA208856
TYPE
ANDA
ORIGINAL APPROVAL
2019-08-07
LATEST ACTION
2026-02-12
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
2026-02-12Labeling · Supplement 3 · standardAP
2019-08-07UNKNOWN · 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.
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