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Celecoxib - Generic Drug Details

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Celecoxib is the generic ingredient in two branded drugs marketed by Alembic Pharms Ltd, Aurobindo Pharma Ltd, Lupin Ltd, Cipla Ltd, Mylan Pharms Inc, Watson Labs Inc, Torrent Pharms Ltd, Macleods Pharms Ltd, Apotex Inc, Gd Searle, and Teva, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for celecoxib. Forty-five suppliers are listed for this compound.

Summary for Generic Name: celecoxib

Tradenames:2
Patents:0
Applicants:11
NDAs:11
Drug Master File Entries: see list23
Suppliers / Packaging: see list45
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: celecoxib

Clinical Trials for: celecoxib

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd
CELECOXIB
celecoxib
CAPSULE;ORAL202240-002Jun 9, 2015RXNo<disabled><disabled>
Macleods Pharms Ltd
CELECOXIB
celecoxib
CAPSULE;ORAL204590-004Mar 16, 2016RXNo<disabled><disabled>
Mylan Pharms Inc
CELECOXIB
celecoxib
CAPSULE;ORAL078857-001May 30, 2014RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: celecoxib

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gd Searle
CELEBREX
celecoxib
CAPSULE;ORAL020998-003Aug 29, 2002RE44048*PED<disabled>
Gd Searle
CELEBREX
celecoxib
CAPSULE;ORAL020998-002Dec 31, 19985,466,823*PED<disabled>
Gd Searle
CELEBREX
celecoxib
CAPSULE;ORAL020998-004Dec 15, 20065,760,068*PED<disabled>
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