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. It is available from twenty suppliers. 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. Fifty-five suppliers are listed 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

Pharmacology for NDA: 020998

Ingredient-type	Nonsteroidal Anti-inflammatory Compounds
Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 020998

Cyclooxygenase 2 Inhibitors

Suppliers and Packaging for NDA: 020998

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CELEBREX	celecoxib	CAPSULE;ORAL	020998	NDA	G.D. Searle LLC Division of Pfizer Inc	0025-1515	0025-1515-01	60 CAPSULE in 1 BOTTLE (0025-1515-01)
CELEBREX	celecoxib	CAPSULE;ORAL	020998	NDA	G.D. Searle LLC Division of Pfizer Inc	0025-1520	0025-1520-31	100 CAPSULE in 1 BOTTLE (0025-1520-31)

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

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