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EPCLUSA (nda208341)- (200MG;50MG,400MG;100MG)

SOFOSBUVIR; VELPATASVIR GILEAD SCIENCES INC
200MG;50MG,400MG;100MG
No No
2034-Jul-30 2021-Jun-28
None None
None No
EPCLUSA is a fixed-dose combination of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A inhibitor, and is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection: • without cirrhosis or with compensated cirrhosis • with decompensated cirrhosis for use in combination with ribavirin.
0 0 0
Total Other Developers 1
Drugs with Suitability No
200MG;50MG ** ** - - -
400MG;100MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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