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CERDELGA (nda205494)- (EQ 84MG BASE)

ELIGLUSTAT TARTRATE GENZYME CORP
EQ 84MG BASE
Yes No
2038-Dec-13 2019-Aug-19
2021-Aug-19 None
None No
CERDELGA is a glucosylceramide synthase inhibitor indicated for the long term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.
5 0 0
Total Other Developers 4
Drugs with Suitability No
EQ 84MG BASE ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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