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CALQUENCE (nda210259)- (100MG)

ACALABRUTINIB ASTRAZENECA
100MG
Yes No
2036-Jul-01 2022-Oct-31
None None
None No
CALQUENCE is a kinase inhibitor indicated for the treatment of adult patients with: • Mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. • Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
0 2 0
Total Other Developers 9
Drugs with Suitability No
100MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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