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TAGRISSO (nda208065)- (EQ 40MG BASE,EQ 80MG BASE)

OSIMERTINIB MESYLATE ASTRAZENECA
EQ 40MG BASE,EQ 80MG BASE
Yes No
2035-Jan-02 2020-Nov-13
2022-Nov-13 None
None No
TAGRISSO is a kinase inhibitor indicated for: • as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test • the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. • the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy.
0 3 0
Total Other Developers 3
Drugs with Suitability No
EQ 40MG BASE ** ** - - -
EQ 80MG BASE ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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