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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. It is available from thirty suppliers. Additional details are available on the CELEBREX profile page.

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

Summary for NDA: 020998

Tradename:
CELEBREX
Applicant:
Gd Searle
Ingredient:
celecoxib
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020998

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Dec 31, 1998TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Dec 31, 1998TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength400MG
Approval Date:Aug 29, 2002TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 020998

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gd Searle
CELEBREX
celecoxib
CAPSULE;ORAL020998-002Dec 31, 19985,760,068*PED► subscribe
Gd Searle
CELEBREX
celecoxib
CAPSULE;ORAL020998-003Aug 29, 20025,760,068*PED► subscribe
Gd Searle
CELEBREX
celecoxib
CAPSULE;ORAL020998-004Dec 15, 20065,466,823*PED► subscribe
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