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HARVONI (nda205834)- (45MG;200MG,90MG;400MG)

LEDIPASVIR; SOFOSBUVIR GILEAD SCIENCES INC
45MG;200MG,90MG;400MG
No No
2034-Jul-30 2019-Oct-10
2024-Apr-07 None
None No
HARVONI is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, and is indicated for the treatment of chronic hepatitis C virus (HCV) in adults and pediatric patients 3 years of age and older: • Genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis • Genotype 1 infection with decompensated cirrhosis, in combination with ribavirin • Genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with ribavirin.
0 0 0
Total Other Developers 1
Drugs with Suitability No
45MG;200MG ** ** - - -
90MG;400MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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