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IMBRUVICA (nda205552)- (70MG,140MG)

IBRUTINIB PHARMACYCLICS LLC
70MG,140MG
Yes No
2035-Apr-24 2018-Nov-13
2020-Nov-13 None
None No
IMBRUVICA is a kinase inhibitor indicated for the treatment of adult patients with: • Mantle cell lymphoma (MCL) who have received at least one prior therapy. • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL). • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion. • Waldenström’s macroglobulinemia (WM). • Marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. • Chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.
0 3 0
Total Other Developers None
Drugs with Suitability No
70MG ** ** - - -
140MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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