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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, Lupin Ltd, Mylan Pharms Inc, Teva, and Watson Labs Inc, and is included in five 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-four 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: see list24
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

The Impact of Genotype on Plasma and Cerebral Spinal Fluid Pharmacokinetics of Celecoxib in Children
Status: Not yet recruiting Condition: Pharmacokinetics of Celecoxib in Children

Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer
Status: Completed Condition: Breast Neoplasms; Breast Cancer

Pregabalin, Celecoxib, Total Knee Arthroplasty and Intrathecal Morphine
Status: Completed Condition: Postoperative Pain Management; Total Knee Arthroplasty

Celecoxib for Pediatric Adenotonsillectomy
Status: Completed Condition: Tonsillectomy; Adenotonsillectomy; Pain, Postoperative

CPT-11/Cisplatin and Celecoxib With Radiation Therapy for Patients With Unresectable Non-Small Cell Lung Cancer (NSCLC)
Status: Completed Condition: Lung Cancer

Celecoxib as a Post-tonsillectomy Pain Medication
Status: Active, not recruiting Condition: Tonsillitis

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc
CAPSULE;ORAL078857-004Feb 11, 2015RXNo<disabled><disabled>
Gd Searle
CAPSULE;ORAL020998-004Dec 15, 2006RXNo5,760,068*PED<disabled>Y<disabled>
Gd Searle
CAPSULE;ORAL020998-002Dec 31, 1998RXNoRE44048*PED<disabled><disabled>
Watson Labs Inc
CAPSULE;ORAL200562-001Feb 11, 2015RXNo<disabled><disabled>
Gd Searle
CAPSULE;ORAL020998-004Dec 15, 2006RXNoRE44048*PED<disabled><disabled>
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Preferred citation:

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

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