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Details for Generic Name: capecitabine

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Capecitabine is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Mylan Pharms Inc, Teva Pharms Usa, and Hoffmann La Roche, and is included in four 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

Drug Master File Entries: see list26
Suppliers / Packaging: see list12

Pharmacology for Ingredient: capecitabine

Clinical Trials for: capecitabine

A Study of Temsirolimus Plus Capecitabine in Patients With Advanced Cancer
Status: Completed Condition: Advanced Solid Tumors

LBH589 in Combination With Capecitabine Plus/Minus (±) Lapatinib in Breast Cancer Patients
Status: Completed Condition: Breast Cancer

Capecitabine + Bendamustine in Women With Pretreated Locally Advanced or Metastatic Her2-negative Breast Cancer
Status: Active, not recruiting Condition: Breast Cancer

Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer
Status: Not yet recruiting Condition: Breast Cancer

Safety Study of a New Schedule of Capecitabine and Docetaxel to Treat Cancers
Status: Completed Condition: Metastatic Breast Cancer

Sorafenib With Capecitabine for Patients With Measurable Hepatocellular Carcinoma
Status: Terminated Condition: Hepatocellular Carcinoma

A Study Of Neratinib (HKI-272) And Capecitabine In Japanese With Solid Tumor
Status: Completed Condition: Advanced Malignant Solid Tumors

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
TABLET;ORAL090943-002Aug 8, 2014RXNo<disabled><disabled>
Hoffmann La Roche
TABLET;ORAL020896-001Apr 30, 1998RXNo<disabled><disabled>
Teva Pharms Usa
TABLET;ORAL091649-002Sep 16, 2013RXNo<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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