Application 209195
- Type
- NDA
- Sponsor
- GILEAD SCIENCES INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VOSEVI | SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR | TABLET;ORAL | 400MG;100MG;100MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 61958-2401 | Vosevi | SOFOSBUVIR, VELPATASVIR, and VOXILAPREVIR | Gilead Sciences, Inc. | NDA | Current |
| 61958-2401 | Vosevi | SOFOSBUVIR, VELPATASVIR, and VOXILAPREVIR | Gilead Sciences, Inc. | NDA | Current |
| 61958-2401 | Vosevi | SOFOSBUVIR, VELPATASVIR, and VOXILAPREVIR | Gilead Sciences, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 60970 | SUPPL | 2019-11-19 |
| 60883 | SUPPL | 2019-11-19 |
| 60203 | SUPPL | 2019-10-02 |
| 60161 | SUPPL | 2019-09-30 |
| 50395 | SUPPL | 2017-11-13 |
| 50377 | SUPPL | 2017-11-13 |
| 49650 | ORIG | 2017-09-01 |
| 49031 | ORIG | 2017-07-21 |
| 49016 | ORIG | 2017-07-19 |