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NERLYNX (nda208051)- (EQ 40MG BASE)

NERATINIB MALEATE PUMA BIOTECH
EQ 40MG BASE
Yes No
2031-Jul-18 2022-Jul-17
None None
None No
NERLYNX is a kinase inhibitor indicated: • As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumabbased therapy. • In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.
0 1 0
Total Other Developers 2
Drugs with Suitability No
EQ 40MG BASE ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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