APPLICATION
ANDA078857
TYPE
ANDA
ORIGINAL APPROVAL
2014-05-30
LATEST ACTION
2022-03-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
CELECOXIBDiscontinued
CELECOXIB 200MG · CAPSULE · ORAL
CELECOXIBDiscontinued
CELECOXIB 50MG · CAPSULE · ORAL
CELECOXIBDiscontinued
CELECOXIB 400MG · CAPSULE · ORAL
CELECOXIBDiscontinued
CELECOXIB 100MG · CAPSULE · ORAL
Approval history
2022-03-09Labeling · Supplement 13 · standardAP
2019-10-09Labeling · Supplement 7 · standardAP
2019-04-02Labeling · Supplement 5 · standardAP
2016-09-16Labeling · Supplement 3 · standardAP
2015-11-10Manufacturing (CMC) · Supplement 1 · unknownAP
2015-02-11OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.