Celebrex

Manages OA. 1.2 Rheumatoid Arthritis (RA). NDA 20998, held by Upjohn. Celecoxib.

As of Nov 14, 2026, NDA 20998 (Celebrex), held by Upjohn, was first approved by FDA on Dec 31, 1998, with 30 approved supplements and 0 published complete response letters.

First approved: Dec 31, 1998
Review: Priority
Supplements approved: 30
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

CELEBREX is indicated CELEBREX is a nonsteroidal anti-inflammatory drug indicated for:

Osteoarthritis (OA)
Rheumatoid Arthritis (RA)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older
Ankylosing Spondylitis (AS)
Acute Pain (AP)
Primary Dysmenorrhea (PD) 1.1 Osteoarthritis (OA) For the management of the signs and symptoms of OA. 1.2 Rheumatoid Arthritis (RA) For the management of the signs and symptoms of RA. 1.3 Juvenile Rheumatoid Arthritis (JRA) For the management of the signs and symptoms of JRA in patients 2 years and older. 1.4 Ankylosing Spondylitis (AS) For the management of the signs and symptoms of AS. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 31 submissions below


Jun 28, 2018	Supplement 50Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 31, 2008	Supplement 27Efficacy (new indication or use)	Approved	Label Letter
Dec 15, 2006	Supplement 21Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric Written Request
Jul 29, 2005	Supplement 18Efficacy (new indication or use)	Approved	Letter Label
Jun 7, 2002	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Label Letter Review
Oct 18, 2001	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Dec 31, 1998	Original applicationNew molecular entity · Priority review	Approved	Label Letter Review

Products

4 strengths and forms


Celebrex100MG · capsule;oral	Celecoxib	RxReference drug
Celebrex200MG · capsule;oral	Celecoxib	RxReference drug
Celebrex400MG · capsule;oral	Celecoxib	RxReference drug
Celebrex50MG · capsule;oral	Celecoxib	RxReference drug

All 31 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 58Labeling · Standard review	Approved	Label Medication Guide Letter
Apr 28, 2021	Supplement 56Labeling · Standard review	Approved	Label Letter
May 3, 2019	Supplement 54Labeling · Standard review	Approved	Letter Label
Jun 28, 2018	Supplement 50Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 9, 2016	Supplement 48Labeling · Standard review	Approved	Letter Label
May 9, 2016	Supplement 47Labeling · Standard review	Approved	Letter
Jul 28, 2014	Supplement 45Manufacturing · Priority review	Approved	None posted
Jul 29, 2013	Supplement 42Manufacturing · Priority review	Approved	None posted
Nov 16, 2012	Supplement 41Manufacturing · Priority review	Approved	None posted
Feb 4, 2011	Supplement 33Labeling · Standard review	Approved	Label Letter
Dec 31, 2008	Supplement 27Efficacy (new indication or use)	Approved	Label Letter
Jan 14, 2008	Supplement 26Labeling · Standard review	Approved	Label Letter
Nov 2, 2007	Supplement 23Labeling · Standard review	Approved	Letter
Jun 1, 2007	Supplement 22Labeling · Standard review	Approved	Letter Label
Dec 15, 2006	Supplement 21Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric Written Request
Jul 29, 2005	Supplement 19Labeling · Standard review	Approved	Label Letter
Jul 29, 2005	Supplement 18Efficacy (new indication or use)	Approved	Letter Label
Feb 9, 2005	Supplement 17Labeling · Standard review	Approved	Letter Label
Jan 9, 2004	Supplement 16Labeling · Standard review	Approved	Review Label Letter
Sep 16, 2002	Supplement 14Manufacturing · Priority review	Approved	Review
Aug 29, 2002	Supplement 13Manufacturing · Priority review	Approved	Review Letter
Jun 7, 2002	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Label Letter Review
Oct 18, 2001	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Aug 15, 2001	Supplement 12Manufacturing · Priority review	Approved	None posted
Jul 30, 2001	Supplement 11Manufacturing · Priority review	Approved	None posted
Dec 1, 2000	Supplement 8Labeling · Standard review	Approved	Review
Mar 21, 2000	Supplement 6Manufacturing · Priority review	Approved	Review
Feb 17, 2000	Supplement 4Manufacturing · Priority review	Approved	Review
Dec 23, 1999	Supplement 7Labeling · Standard review	Approved	Label Review Letter
Aug 13, 1999	Supplement 1Manufacturing · Priority review	Approved	Review
Dec 31, 1998	Original applicationNew molecular entity · Priority review	Approved	Label Letter Review

Identifiers

Application: NDA 20998
Drugs@FDA: Overview at FDA
Company: Upjohn

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters