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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

Tradenames:2
Patents:0
Applicants:4
NDAs:4
Drug Master File Entries: see list26
Suppliers / Packaging: see list12
Formulation / Manufacturing:see details

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

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

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

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

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

Capecitabine Maintenance Therapy Following Capecitabine Combined With Docetaxel in Treatment of mBC
Status: Recruiting Condition: Breast Neoplasms; Neoplasms by Site; Neoplasm Metastasis; Breast Diseases; Skin Diseases

Courtesy of ClinicalTrials.org
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
Teva Pharms Usa
CAPECITABINE
capecitabine
TABLET;ORAL091649-001Sep 16, 2013RXNo<disabled><disabled>
Hoffmann La Roche
XELODA
capecitabine
TABLET;ORAL020896-002Apr 30, 1998RXYes<disabled><disabled>
Accord Hlthcare
CAPECITABINE
capecitabine
TABLET;ORAL202593-001Apr 23, 2015RXNo<disabled><disabled>
Mylan Pharms Inc
CAPECITABINE
capecitabine
TABLET;ORAL090943-001Aug 8, 2014RXNo<disabled><disabled>
Teva Pharms Usa
CAPECITABINE
capecitabine
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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