APPLICATION
ANDA207677
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-23
LATEST ACTION
2025-02-26
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
2025-02-26Labeling · Supplement 7 · standardAP
2022-11-01Labeling · Supplement 6 · standardAP
2019-08-20Labeling · Supplement 3 · standardAP
2019-08-20Labeling · Supplement 2 · standardAP
2016-09-15Labeling · Supplement 1 · standardAP
2015-12-23UNKNOWN · 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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