FDA ANDA · ANDA213301
CELECOXIB
Sponsor: UNICHEM
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APPLICATION
ANDA213301
TYPE
ANDA
ORIGINAL APPROVAL
2021-01-12
LATEST ACTION
2026-10-02
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
2026-10-02Labeling · Supplement 6 · standardAP
2021-12-14Labeling · Supplement 2 · standardAP
2021-01-12UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →