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TYKERB (nda022059)- (EQ 250MG BASE)

LAPATINIB DITOSYLATE NOVARTIS
EQ 250MG BASE
Yes No
2029-Sep-18 2012-Mar-13
None None
None No
TYKERB is a kinase inhibitor indicated in combination with: • capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. • letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated.
2 0 1
Total Other Developers 1
Drugs with Suitability No
EQ 250MG BASE ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 1
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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