Application Nr Approved Date Route Status External Links
NDA205834 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Ledipasvir And Sofosbuvir Is Indicated For The Treatment Of Adults And Pediatric Patients 3 Years Of Age And Older With Chronic Hepatitis C Virus (Hcv) [See Dosage And Administration (2.2 And 2.3) And Clinical Studies (14) ]: Genotype 1, 4, 5, Or 6 Infection Without Cirrhosis Or With Compensated Cirrhosis Genotype 1 Infection With Decompensated Cirrhosis, For Use In Combination With Ribavirin Genotype 1 Or 4 Infection Who Are Liver Transplant Recipients Without Cirrhosis Or With Compensated Cirrhosis, For Use In Combination With Ribavirin Ledipasvir And Sofosbuvir 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. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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