NDC Code | 72626-2601-1 |
Package Description | 2 BLISTER PACK in 1 CARTON (72626-2601-1) / 14 TABLET, FILM COATED in 1 BLISTER PACK |
Product NDC | 72626-2601 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Ledipasvir And Sofosbuvir |
Non-Proprietary Name | Ledipasvir And Sofosbuvir |
Dosage Form | TABLET, FILM COATED |
Usage | ORAL |
Start Marketing Date | 20190101 |
Marketing Category Name | NDA AUTHORIZED GENERIC |
Application Number | NDA205834 |
Manufacturer | Asegua Therapeutics LLC |
Substance Name | LEDIPASVIR; SOFOSBUVIR |
Strength | 90; 400 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Breast Cancer Resistance Protein Inhibitors [MoA], Hepatitis C Virus NS5A Inhibitor [EPC], Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], RNA Replicase Inhibitors [MoA] |