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Details for Generic Name: capecitabine

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Capecitabine is the generic ingredient in two branded drugs marketed by Mylan Pharms Inc, Teva Pharms Usa, and Hoffmann La Roche, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for capecitabine. Three suppliers are listed for this compound.

Summary for Generic Name: capecitabine

Tradenames:2
Patents:0
Applicants:3
NDAs:3
Drug Master File Entries: see list26
Suppliers: see list3
Formulation / Manufacturing:see details

Pharmacology for Ingredient: capecitabine

Clinical Trials for: capecitabine

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc
CAPECITABINE
capecitabine
TABLET;ORAL090943-002Aug 8, 2014RXNo<disabled><disabled>
Hoffmann La Roche
XELODA
capecitabine
TABLET;ORAL020896-002Apr 30, 1998RXYes<disabled><disabled>
Mylan Pharms Inc
CAPECITABINE
capecitabine
TABLET;ORAL090943-001Aug 8, 2014RXNo<disabled><disabled>
Hoffmann La Roche
XELODA
capecitabine
TABLET;ORAL020896-002Apr 30, 1998RXYes<disabled><disabled>
Hoffmann La Roche
XELODA
capecitabine
TABLET;ORAL020896-001Apr 30, 1998RXNo<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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