Application Nr Approved Date Route Status External Links
NDA208341 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Sofosbuvir And Velpatasvir Is Indicated For The Treatment Of Adults And Pediatric Patients 6 Years Of Age And Older Or Weighing At Least 17 Kg With Chronic Hepatitis C Virus (Hcv) Genotype 1, 2, 3, 4, 5, Or 6 Infection [See Dosage And Administration (2.2 , 2.3 , 2.4 ) And Clinical Studies (14) ] : Without Cirrhosis Or With Compensated Cirrhosis With Decompensated Cirrhosis For Use In Combination With Ribavirin. Sofosbuvir And Velpatasvir 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 Adult And Pediatric Patients 6 Years Of Age And Older Or Weighing At Least 17 Kg With Chronic Hcv Genotype 1, 2, 3, 4, 5, Or 6 Infection ( 1 ): Without Cirrhosis Or With Compensated Cirrhosis With Decompensated Cirrhosis For Use In Combination With Ribavirin

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Sofosbuvir SOFOSBUVIR ZINC100074252
2. Velpatasvir

Comments