Application 214187
- Type
- NDA
- Sponsor
- GILEAD SCIENCES INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EPCLUSA | SOFOSBUVIR;VELPATASVIR | PELLETS;ORAL | 200;50MG | No | No |
| 002 | EPCLUSA | SOFOSBUVIR;VELPATASVIR | PELLETS;ORAL | 150;37.5MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 61958-2204 | Epclusa | Velpatasvir and Sofosbuvir | Gilead Sciences, Inc. | NDA | Current |
| 61958-2204 | Epclusa | Velpatasvir and Sofosbuvir | Gilead Sciences, Inc. | NDA | Current |
| 61958-2205 | Epclusa | Velpatasvir and Sofosbuvir | Gilead Sciences, Inc. | NDA | Current |
| 61958-2205 | Epclusa | Velpatasvir and Sofosbuvir | Gilead Sciences, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 70857 | SUPPL | 2022-04-29 |
| 70843 | SUPPL | 2022-04-28 |
| 69421 | ORIG | 2021-11-29 |
| 67775 | ORIG | 2021-06-14 |
| 67766 | ORIG | 2021-06-11 |