Sofosbuvir; Velpatasvir
Sold as Epclusa. Every FDA application for this active ingredient.
- First approved: Jun 28, 2016
- Applications: 2
- New uses approved: 7
- Complete response letters: 0
Applications
NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Jun 28, 2016 | EpclusaNDA 208341 · New molecular entity, new combination | Gilead Sciences Inc | 11 | Marketed |
| Jun 10, 2021 | EpclusaNDA 214187 · New dosage form | Gilead Sciences Inc | 1 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Drugs@FDA