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RYDAPT (nda207997)- (25MG)

MIDOSTAURIN NOVARTIS
25MG
Yes No
2030-Dec-02 2022-Apr-28
2024-Apr-28 None
None No
RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: • Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutationpositive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. • Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).
3 1 0
Total Other Developers 11
Drugs with Suitability No
25MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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