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Last Updated: May 21, 2022

Details for New Drug Application (NDA): 020998


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NDA 020998 describes CELEBREX, which is a drug marketed by Upjohn and is included in one NDA. It is available from six 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-three suppliers are listed for this compound. Additional details are available on the celecoxib profile page.
Summary for 020998
Tradename:CELEBREX
Applicant:Upjohn
Ingredient:celecoxib
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020998
Mechanism of Action Cyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 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 Pfizer Laboratories Div Pfizer Inc 0025-1515 0025-1515-01 60 CAPSULE in 1 BOTTLE (0025-1515-01)
CELEBREX celecoxib CAPSULE;ORAL 020998 NDA Pfizer Laboratories Div Pfizer Inc 0025-1520 0025-1520-31 100 CAPSULE in 1 BOTTLE (0025-1520-31)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Dec 31, 1998TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Dec 31, 1998TE:ABRLD:Yes

Profile for product number 003

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

Expired US Patents for NDA 020998

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Upjohn CELEBREX celecoxib CAPSULE;ORAL 020998-001 Dec 31, 1998 See Plans and Pricing See Plans and Pricing
Upjohn CELEBREX celecoxib CAPSULE;ORAL 020998-003 Aug 29, 2002 See Plans and Pricing See Plans and Pricing
Upjohn CELEBREX celecoxib CAPSULE;ORAL 020998-002 Dec 31, 1998 See Plans and Pricing See Plans and Pricing
Upjohn CELEBREX celecoxib CAPSULE;ORAL 020998-004 Dec 15, 2006 See Plans and Pricing See Plans and Pricing
Upjohn CELEBREX celecoxib CAPSULE;ORAL 020998-003 Aug 29, 2002 See Plans and Pricing See Plans and Pricing
Upjohn CELEBREX celecoxib CAPSULE;ORAL 020998-001 Dec 31, 1998 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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