← FDA DRUG APPROVALS

FDA NDA · NDA021156

CELEBREX

Sponsor: GD SEARLE LLC

APPLICATION
NDA021156
TYPE
NDA
ORIGINAL APPROVAL
1999-12-23
LATEST ACTION
2011-02-04
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

CELEBREXPrescription
CELECOXIB 200MG · CAPSULE · ORAL
CELEBREXPrescription
CELECOXIB 400MG · CAPSULE · ORAL
CELEBREXPrescription
CELECOXIB 100MG · CAPSULE · ORAL

Approval history

2011-02-04Labeling · Supplement 3 · unknown — Medication Guide ↗AP
2002-08-29Manufacturing (CMC) · Supplement 2 · priority — Letter ↗AP
2002-08-29Manufacturing (CMC) · Supplement 1 · priority — Letter ↗AP
1999-12-23Type 6 - New Indication (no longer used) · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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