APPLICATION
ANDA208833
TYPE
ANDA
ORIGINAL APPROVAL
2018-05-31
LATEST ACTION
2023-01-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
CELECOXIBDiscontinued
CELECOXIB 400MG · CAPSULE · ORAL
CELECOXIBDiscontinued
CELECOXIB 100MG · CAPSULE · ORAL
CELECOXIBDiscontinued
CELECOXIB 200MG · CAPSULE · ORAL
CELECOXIBDiscontinued
CELECOXIB 50MG · CAPSULE · ORAL
Approval history
2023-01-10Labeling · Supplement 5 · standardAP
2023-01-10Labeling · Supplement 6 · standardAP
2019-10-01Labeling · Supplement 2 · standardAP
2019-04-02Labeling · Supplement 1 · standardAP
2018-05-31UNKNOWN · 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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