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Last Updated: January 16, 2021

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Details for New Drug Application (NDA): 020998

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NDA 020998 describes CELEBREX, which is a drug marketed by Gd Searle and is included in one NDA. Additional details are available on the CELEBREX profile page.

The generic ingredient in CELEBREX is celecoxib. There are twenty-six drug master file entries for this compound. Additional details are available on the celecoxib profile page.

Summary for 020998

Tradename:	CELEBREX
Applicant:	Gd Searle
Ingredient:	celecoxib
Patents:	0
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 020998

Cyclooxygenase 2 Inhibitors

Paragraph IV (Patent) Challenges for 020998

Tradename	Dosage	Ingredient	NDA	Submissiondate
CELEBREX	CAPSULE;ORAL	celecoxib	020998	2008-03-21

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Dec 31, 1998	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Dec 31, 1998	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	400MG
Approval Date:	Aug 29, 2002	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020998

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gd Searle	CELEBREX	celecoxib	CAPSULE;ORAL	020998-003	Aug 29, 2002	Start Trial	Start Trial
Gd Searle	CELEBREX	celecoxib	CAPSULE;ORAL	020998-004	Dec 15, 2006	Start Trial	Start Trial
Gd Searle	CELEBREX	celecoxib	CAPSULE;ORAL	020998-002	Dec 31, 1998	Start Trial	Start Trial
Gd Searle	CELEBREX	celecoxib	CAPSULE;ORAL	020998-002	Dec 31, 1998	Start Trial	Start Trial
Gd Searle	CELEBREX	celecoxib	CAPSULE;ORAL	020998-001	Dec 31, 1998	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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