Is Celecoxib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 32 valid registrations of Celecoxib, including BREXEL (200 mg, Capsule, hard, SAR 37.50); CEBO 200 MG CAPSULE (200 mg, Capsule, hard, SAR 27.85); CELEBREX 100MG CAPSULE (100 mg, Capsule, hard, SAR 24.95); CELEBREX 200MG CAPSULE (200 mg, Capsule, hard, SAR 40.50); CELEBREX 400 mg capsule (400 mg, Capsule, hard, SAR 55.45).

Is Celecoxib approved by the US FDA?

Drugs@FDA lists 30 application product lines for Celecoxib, including CELEBREX (Prescription); CELEBREX (Prescription); CELECOXIB (Prescription); CELECOXIB (Prescription); CELECOXIB (Prescription).

Is Celecoxib authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Celecoxib.

Are there safety signals or safety updates for Celecoxib?

US FDA: 4 entries (latest 2024-11-21).

Active substance

Celecoxib

SFDA 47
US FDA 30
EMA 1
Health Canada 30
US price lines 8
NHS prices 2
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
BREXEL	200 mg	Capsule, hard · Oral use	30 Bottle	SAR 37.50	Generic · Prescription	Doctors Pharmaceutical manufacturer	Valid
CEBO 200 MG CAPSULE	200 mg	Capsule, hard · Oral use	20 Blister	SAR 27.85	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
CELEBREX 100MG CAPSULE	100 mg	Capsule, hard · Oral use	20 Blister	SAR 24.95	NCE · Prescription	PFIZER SAUDI LIMITED	Valid
CELEBREX 200MG CAPSULE	200 mg	Capsule, hard · Oral use	20 Blister	SAR 40.50	NCE · Prescription	Viatris Arabia Limited	Valid
CELEBREX 200MG CAPSULE	200 mg	Capsule, hard · Oral use	10 Blister	SAR 21.95	NCE · Prescription	Viatris Arabia Limited	Valid
CELEBREX 400 mg capsule	400 mg	Capsule, hard · Oral use	10 Blister	SAR 55.45	NCE · Prescription	PHARMACIA UPJOHN	Valid
CELECT 100 MG CAPSULE	100 mg	Capsule, hard · Oral use	20 Blister	SAR 19.10	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
CELECT 200 MG CAPSULE	200 mg	Capsule, hard · Oral use	20 Blister	SAR 30.95	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
COXICEL 200 MG HARD CAPSULE	200 mg	Capsule, hard · Oral use	10 Blister	SAR 13.90	Generic · Prescription	LABORATORIOS CINFA SA	Valid
COXICEL 200 MG HARD CAPSULE	200 mg	Capsule, hard · Oral use	20 Blister	SAR 27.85	Generic · Prescription	LABORATORIOS CINFA SA	Valid
COXICEL 200 MG HARD CAPSULE	200 mg	Capsule, hard · Oral use	30 Blister	SAR 41.80	Generic · Prescription	LABORATORIOS CINFA SA	Valid
Cebatix	200 mg	Capsule, hard · Oral use	30 Bottle	SAR 37.50	Generic · Prescription	BATTERJEE PHARMACETICAL FACTORY	Valid
Celenax	200 mg	Capsule, hard · Oral use	20 Blister	SAR 25.00	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
Coxido	200 mg	Capsule, hard · Oral use	20 Blister	SAR 25.00	Generic · Prescription	Apex Pharma	Valid
Coxinix	200 mg	Capsule, hard · Oral use	20 Blister	SAR 25.05	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Dolibz	200 mg	Capsule · Oral use	20 Blister	SAR 25.00	Generic · Prescription	Aurobindo Pharma Saudi Arabia Limited	Valid
Dolibz	100 mg	Capsule · Oral use	20 Blister	SAR 12.50	Generic · Prescription	Aurobindo Pharma Saudi Arabia Limited	Valid
FLAMEX 200 MG CAPSULE	200 mg	Capsule, hard · Oral use	10 Blister	SAR 12.50	Generic · Prescription	Jordan Sweden Medical and Sterilization Co.	Valid
FLAMEX 400MG CAPSULE	400 mg	Capsule, hard · Oral use	10 Blister	SAR 22.65	Generic · Prescription	Jordan Sweden Medical and Sterilization Co.	Valid
Flamex	200 mg	Capsule · Oral use	30 Blister	SAR 37.50	Generic · Prescription	JORDAN SWEEDEN COMPANY	Valid
Flamex	400 mg	Capsule · Oral use	30 Blister	SAR 67.95	Generic · Prescription	JORDAN SWEEDEN COMPANY	Valid
Gloxib	200 mg	Capsule · Oral use	30 Blister	SAR 37.50	Generic · Prescription	GLOBAL PHARMA CO LLC	Valid
Gloxib	200 mg	Capsule · Oral use	20 Blister	SAR 25.00	Generic · Prescription	GLOBAL PHARMA CO LLC	Valid
Gloxib	200 mg	Capsule · Oral use	10 Blister	SAR 12.50	Generic · Prescription	GLOBAL PHARMA CO LLC	Valid
PEDEXA	200 mg	Capsule · Oral use	10 Blister	SAR 12.50	Generic · Prescription	DAR ALDAWA	Valid

22 more — full table

Indications — CHI Daman Drug Formulary

ACUTE PANCREATITIS-PAIN MANAGEMENT; ANKYLOSING SPONDYLITIS; ANXIETY DISORDERS; CHRONIC PANCREATITIS; DENTAL ABSCESS-DENTAL PAIN; ENDOMETRIOSIS; ENTEROPATHIC ARTHROPATHIES, UNSPECIFIED SITE REACTIVE ARTHROPATHY, UNSPECIFIED; GOUT; JUVENILE IDIOPATHIC ARTHRITIS (JIA); LOW BACK PAIN; MENSTRUAL DISORDERS; MUCOSAL ULCERATION-SUPPORTIVE AGENTS; OSTEOARTHRITIS; PAIN MANAGEMENT IN CANCER PATIENTS; POSTOPERATIVE PAIN; PSORIATIC ARTHRITIS; RENAL AND URETERIC STONES; RHEUMATOID ARITHRITIS; SICKLE CELL DISEASE - PAIN MANAGEMENT

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
CELEBREX	100MG; 200MG; 400MG; 50MG	capsule · oral	UPJOHN	Prescription	31 Dec 1998
CELEBREX	100MG; 200MG; 400MG	capsule · oral	GD SEARLE LLC	Prescription	23 Dec 1999
CELECOXIB	50MG; 100MG; 200MG; 400MG	capsule · oral	TEVA	Prescription	30 May 2014
CELECOXIB	50MG; 100MG; 200MG; 400MG	capsule · oral	LUPIN	Prescription	29 Oct 2014
CELECOXIB	50MG; 100MG; 200MG; 400MG	capsule · oral	WATSON LABS INC	Prescription	11 Feb 2015
CELECOXIB	50MG; 100MG; 200MG	capsule · oral	APOTEX	Prescription	2 Jun 2015
CELECOXIB	50MG; 100MG; 200MG; 400MG	capsule · oral	ALEMBIC	Prescription	21 Aug 2015
CELECOXIB	50MG; 100MG; 200MG; 400MG	capsule · oral	CIPLA	Prescription	23 Sep 2015
CELECOXIB	50MG; 100MG; 200MG; 400MG	capsule · oral	TORRENT	Prescription	23 Dec 2015
CELECOXIB	50MG; 100MG; 200MG; 400MG	capsule · oral	AUROBINDO PHARMA	Prescription	1 Feb 2016
CELECOXIB	50MG; 100MG; 200MG; 400MG	capsule · oral	MACLEODS PHARMS	Prescription	16 Mar 2016
CELECOXIB	50MG; 100MG; 200MG	capsule · oral	CSPC OUYI	Prescription	23 Jan 2018
CELECOXIB	50MG; 100MG; 200MG; 400MG	capsule · oral	MICRO LABS	Prescription	30 Apr 2018
CELECOXIB	50MG; 100MG; 200MG; 400MG	capsule · oral	QINGDAO BAHEAL PHARM	Prescription	7 Aug 2019
CELECOXIB	50MG; 100MG; 200MG; 400MG	capsule · oral	CADILA PHARMS LTD	Prescription	14 Nov 2019
CELECOXIB	50MG; 100MG; 200MG; 400MG	capsule · oral	PHARMAZONE	Prescription	27 Nov 2019
CELECOXIB	50MG; 100MG; 200MG; 400MG	capsule · oral	TIANJIN TIANYAO	Prescription	25 Feb 2020
CELECOXIB	50MG; 100MG; 200MG; 400MG	capsule · oral	YILING	Prescription	6 Mar 2020
ELYXYB	25MG/ML	solution · oral	SCILEX PHARMS	Prescription	5 May 2020
CELECOXIB	200MG	capsule · oral	NANJING	Prescription	13 May 2020
CELECOXIB	50MG; 100MG; 200MG; 400MG	capsule · oral	SCIEGEN PHARMS	Prescription	3 Dec 2020
VYSCOXA	10MG/ML	suspension · oral	CARWIN PHARM ASSOC	Prescription	29 Jul 2025
CELECOXIB	50MG; 100MG; 200MG; 400MG	capsule · oral	PHARMAZONE	Discontinued	30 May 2014
CELECOXIB	50MG; 100MG; 200MG; 400MG	capsule · oral	JUBILANT GENERICS	Discontinued	4 Apr 2017
CELECOXIB	50MG; 100MG; 200MG; 400MG	capsule · oral	AMNEAL PHARMS	Discontinued	31 May 2018

5 more — full table

EMA European Union — centrally authorised medicines

Onsenal Pfizer Limited · Withdrawn · authorised 17 Oct 2003 · ATC L01XX33

Therapeutic indication (EMA)

Onsenal is indicated for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP), as an adjunct to surgery and further endoscopic surveillance (see section 4.4). The effect of Onsenal-induced reduction of polyp burden on the risk of intestinal cancer has not been demonstrated (see sections 4.4 and 5.1)

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AG-CELECOXIB	02437570	100 MG	CAPSULE · ORAL	ANGITA PHARMA INC.
AG-CELECOXIB	02437589	200 MG	CAPSULE · ORAL	ANGITA PHARMA INC.
APO-CELECOXIB	02418932	100 MG	CAPSULE · ORAL	APOTEX INC
APO-CELECOXIB	02418940	200 MG	CAPSULE · ORAL	APOTEX INC
AURO-CELECOXIB	02445670	100 MG	CAPSULE · ORAL	AURO PHARMA INC
AURO-CELECOXIB	02445689	200 MG	CAPSULE · ORAL	AURO PHARMA INC
BIO-CELECOXIB	02426382	100 MG	CAPSULE · ORAL	BIOMED PHARMA
BIO-CELECOXIB	02426390	200 MG	CAPSULE · ORAL	BIOMED PHARMA
CELEBREX	02239941	100 MG	CAPSULE · ORAL	BGP PHARMA ULC
CELEBREX	02239942	200 MG	CAPSULE · ORAL	BGP PHARMA ULC
CELECOXIB	02424371	100 MG	CAPSULE · ORAL	PRO DOC LIMITEE
CELECOXIB	02424398	200 MG	CAPSULE · ORAL	PRO DOC LIMITEE
CELECOXIB	02429675	100 MG	CAPSULE · ORAL	SIVEM PHARMACEUTICALS ULC
CELECOXIB	02429683	200 MG	CAPSULE · ORAL	SIVEM PHARMACEUTICALS ULC
CELECOXIB	02436299	100 MG	CAPSULE · ORAL	SANIS HEALTH INC
CELECOXIB	02436302	200 MG	CAPSULE · ORAL	SANIS HEALTH INC
JAMP CELECOXIB	02424533	100 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
JAMP CELECOXIB	02424541	200 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
M-CELECOXIB	02495465	100 MG	CAPSULE · ORAL	MANTRA PHARMA INC
M-CELECOXIB	02495473	200 MG	CAPSULE · ORAL	MANTRA PHARMA INC
MAR-CELECOXIB	02420058	100 MG	CAPSULE · ORAL	MARCAN PHARMACEUTICALS INC
MAR-CELECOXIB	02420066	200 MG	CAPSULE · ORAL	MARCAN PHARMACEUTICALS INC
MINT-CELECOXIB	02412497	100 MG	CAPSULE · ORAL	MINT PHARMACEUTICALS INC
MINT-CELECOXIB	02412500	200 MG	CAPSULE · ORAL	MINT PHARMACEUTICALS INC
NRA-CELECOXIB	02479737	100 MG	CAPSULE · ORAL	NORA PHARMA INC

5 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CELEBREX 100 MG CAPSULE	$9.53398	per EA	23 Sep 2026
US NADAC	CELEBREX 200 MG CAPSULE	$15.64674	per EA	23 Sep 2026
US NADAC	CELEBREX 400 MG CAPSULE	$23.49717	per EA	23 Sep 2026
US NADAC	CELECOXIB 100 MG CAPSULE	$0.0614	per EA	23 Sep 2026
US NADAC	CELECOXIB 200 MG CAPSULE	$0.07623	per EA	23 Sep 2026
US NADAC	CELECOXIB 400 MG CAPSULE	$0.24804	per EA	23 Sep 2026
US NADAC	CELECOXIB 50 MG CAPSULE	$0.09139	per EA	23 Sep 2026
US NADAC	ELYXYB 120 MG/4.8 ML SOLUTION	$30.53807	per ML	23 Sep 2026
NHS Drug Tariff	Celecoxib 100mg capsules	£1.79	60 capsule	1 Oct 2026
NHS Drug Tariff	Celecoxib 200mg capsules	£1.65	30 capsule	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 21 Nov 2024 CELEBREX — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 21 Nov 2024 SEGLENTIS — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 21 Nov 2024 ELYXYB — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 28 Apr 2021 CONSENSI — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for celecoxib →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.