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XELODA (nda020896)- (150MG,500MG)

CAPECITABINE CHEPLAPHARM
150MG,500MG
Yes No
2014-Jun-14 Expired
None None
None No
XELODA (capecitabine) is a nucleoside metabolic inhibitor indicated for: *Colorectal Cancer • adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. • perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. • treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. *Breast Cancer • treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline-or taxane-containing chemotherapy is not indicated. • treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy. *Gastric, Esophageal, or Gastroesophageal Junction Cancer • treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen. (1.3) ● treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen. *Pancreatic Cancer • adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen.
14 0 14
Total Other Developers 4
Drugs with Suitability No
150MG ** ** - - 9
500MG ** ** - - 8
NDA Sales Available Total Generic Sales Available
Yes 12
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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