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Details for Generic Name: celecoxib

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Celecoxib is the generic ingredient in two branded drugs marketed by Gd Searle, Apotex Inc, Lupin Ltd, Mylan Pharms Inc, Teva, and Watson Labs Inc, and is included in six NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for celecoxib. Twenty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: celecoxib

Drug Master File Entries: see list21
Suppliers / Packaging: see list209
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: celecoxib

Tentative approvals for CELECOXIB

Applicant Application No. Form Dosage

Clinical Trials for: celecoxib

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
CAPSULE;ORAL076898-004May 30, 2014RXNo<disabled><disabled>
Gd Searle
CAPSULE;ORAL020998-004Dec 15, 2006RXNo5,760,068*PED<disabled>Y<disabled>
Apotex Inc
CAPSULE;ORAL204197-003Jun 2, 2015RXNo<disabled><disabled>
Mylan Pharms Inc
CAPSULE;ORAL078857-004Feb 11, 2015RXNo<disabled><disabled>
Apotex Inc
CAPSULE;ORAL204197-002Jun 2, 2015RXNo<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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