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GILENYA (nda022527)- (EQ 0.5MG BASE,EQ 0.25MG BASE)

FINGOLIMOD HYDROCHLORIDE NOVARTIS
EQ 0.5MG BASE,EQ 0.25MG BASE
Yes No
2027-Dec-25 2015-Sep-21
None None
None No
GILENYA is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.
15 6 12
Total Other Developers 7
Drugs with Suitability No
EQ 0.5MG BASE ** ** Up - 10
EQ 0.25MG BASE ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 10
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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