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TARCEVA (nda021743)- (EQ 25MG BASE,EQ 100MG BASE,EQ 150MG BASE)

ERLOTINIB HYDROCHLORIDE OSI PHARMS
EQ 25MG BASE,EQ 100MG BASE,EQ 150MG BASE
Yes No
2021-May-09 Expired
None None
None No
TARCEVA is a kinase inhibitor indicated for: • The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. • First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.
10 1 7
Total Other Developers 8
Drugs with Suitability No
EQ 25MG BASE ** ** - - -
EQ 100MG BASE ** ** - - -
EQ 150MG BASE ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 6
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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