# HARVONI
> **NDA212477** · New Drug Application · Sponsor: GILEAD SCIENCES INC · Approved 2019-08-28
## Drug
- **FDA Application Number:** NDA212477
- **Application type:** New Drug Application
- **Brand name:** HARVONI
- **Generic name:** LEDIPASVIR AND SOFOSBUVIR
- **Active ingredients:** LEDIPASVIR; SOFOSBUVIR
- **Dosage form:** PELLETS
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** GILEAD SCIENCES INC
- **Manufacturer:** Gilead Sciences, Inc
- **First approval:** 2019-08-28
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212477)
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*MORVS · CC0 1.0*