← FDA DRUG APPROVALS

FDA NDA · NDA020998

CELEBREX

celecoxib

Sponsor: UPJOHN

APPLICATION
NDA020998
TYPE
NDA
ORIGINAL APPROVAL
1998-12-31
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

CELEBREX · ReferencePrescription
CELECOXIB 50MG · CAPSULE · ORAL
CELEBREX · ReferencePrescription
CELECOXIB 200MG · CAPSULE · ORAL
CELEBREX · ReferencePrescription
CELECOXIB 400MG · CAPSULE · ORAL
CELEBREX · ReferencePrescription
CELECOXIB 100MG · CAPSULE · ORAL

Approval history

2024-11-21Labeling · Supplement 58 · standardLetterAP
2021-04-28Labeling · Supplement 56 · standardLetterAP
2019-05-03Labeling · Supplement 54 · standardLetterAP
2018-06-28Efficacy · Supplement 50 · standardLabelAP
2016-05-09Labeling · Supplement 48 · standardLetterAP
2016-05-09Labeling · Supplement 47 · standardLetterAP
2014-07-28Manufacturing (CMC) · Supplement 45 · priorityAP
2013-07-29Manufacturing (CMC) · Supplement 42 · priorityAP
2012-11-16Manufacturing (CMC) · Supplement 41 · priorityAP
2011-02-04Labeling · Supplement 33 · standardLabelAP
2008-12-31Efficacy · Supplement 27 · unknownLabelAP
2008-01-14Labeling · Supplement 26 · standardLabelAP
2007-11-02Labeling · Supplement 23 · standardLetterAP
2007-06-01Labeling · Supplement 22 · standardLabelAP
2006-12-15Efficacy · Supplement 21 · priorityPediatric Medical ReviewAP
2005-07-29Efficacy · Supplement 18 · unknownLetterAP
2005-07-29Labeling · Supplement 19 · standardLabelAP
2005-02-09Labeling · Supplement 17 · standardLabelAP
2004-01-09Labeling · Supplement 16 · standardLetterAP
2002-09-16Manufacturing (CMC) · Supplement 14 · priorityReviewAP
2002-08-29Manufacturing (CMC) · Supplement 13 · priorityReviewAP
2002-06-07Efficacy · Supplement 9 · standardReviewAP
2001-10-18Efficacy · Supplement 10 · standardLabelAP
2001-08-15Manufacturing (CMC) · Supplement 12 · priorityAP
2001-07-30Manufacturing (CMC) · Supplement 11 · priorityAP
2000-12-01Labeling · Supplement 8 · standardReviewAP
2000-03-21Manufacturing (CMC) · Supplement 6 · priorityReviewAP
2000-02-17Manufacturing (CMC) · Supplement 4 · priorityReviewAP
1999-12-23Labeling · Supplement 7 · standardLabelAP
1999-08-13Manufacturing (CMC) · Supplement 1 · priorityReviewAP
1998-12-31Type 1 - New Molecular Entity · Original · priorityReviewAP
VIEW ON DRUGS@FDA ↗

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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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