Application 208341
- 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 | TABLET;ORAL | 400MG;100MG | Yes | Yes |
| 002 | EPCLUSA | SOFOSBUVIR; VELPATASVIR | TABLET;ORAL | 200MG;50MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 61958-2201 | Epclusa | Velpatasvir and Sofosbuvir | Gilead Sciences, Inc. | NDA | Current |
| 61958-2201 | Epclusa | Velpatasvir and Sofosbuvir | Gilead Sciences, Inc. | NDA | Current |
| 61958-2201 | Epclusa | Velpatasvir and Sofosbuvir | Gilead Sciences, Inc. | NDA | Current |
| 61958-2201 | Epclusa | Velpatasvir and Sofosbuvir | Gilead Sciences, Inc. | NDA | Current |
| 61958-2201 | Epclusa | Velpatasvir and Sofosbuvir | Gilead Sciences, Inc. | NDA | Current |
| 61958-2201 | Epclusa | Velpatasvir and Sofosbuvir | Gilead Sciences, Inc. | NDA | Current |
| 61958-2201 | Epclusa | Velpatasvir and Sofosbuvir | Gilead Sciences, Inc. | NDA | Current |
| 61958-2201 | Epclusa | Velpatasvir and Sofosbuvir | Gilead Sciences, Inc. | NDA | Current |
| 61958-2201 | Epclusa | Velpatasvir and Sofosbuvir | Gilead Sciences, Inc. | NDA | Current |
| 61958-2203 | Epclusa | Velpatasvir and Sofosbuvir | Gilead Sciences, Inc. | NDA | Current |
| 61958-2203 | Epclusa | Velpatasvir and Sofosbuvir | Gilead Sciences, Inc. | NDA | Current |
| 61958-2203 | Epclusa | Velpatasvir and Sofosbuvir | Gilead Sciences, Inc. | NDA | Current |
| 61958-2203 | Epclusa | Velpatasvir and Sofosbuvir | Gilead Sciences, Inc. | NDA | Current |
| 61958-2203 | Epclusa | Velpatasvir and Sofosbuvir | Gilead Sciences, Inc. | NDA | Current |
| 61958-2203 | Epclusa | Velpatasvir and Sofosbuvir | Gilead Sciences, Inc. | NDA | Current |
| 72626-2701 | Sofosbuvir and Velpatasvir | Velpatasvir and Sofosbuvir | Asegua Therapeutics LLC | NDA AUTHORIZED GENERIC | Current |
| 72626-2701 | Sofosbuvir and Velpatasvir | Velpatasvir and Sofosbuvir | Asegua Therapeutics LLC | NDA AUTHORIZED GENERIC | Current |
| 72626-2701 | Sofosbuvir and Velpatasvir | Velpatasvir and Sofosbuvir | Asegua Therapeutics LLC | NDA AUTHORIZED GENERIC | Current |
| 72626-2701 | Sofosbuvir and Velpatasvir | Velpatasvir and Sofosbuvir | Asegua Therapeutics LLC | NDA AUTHORIZED GENERIC | Current |
| 72626-2701 | Sofosbuvir and Velpatasvir | Velpatasvir and Sofosbuvir | Asegua Therapeutics LLC | NDA AUTHORIZED GENERIC | Current |
| 72626-2701 | Sofosbuvir and Velpatasvir | Velpatasvir and Sofosbuvir | Asegua Therapeutics LLC | NDA AUTHORIZED GENERIC | Current |
| 72626-2701 | Sofosbuvir and Velpatasvir | Velpatasvir and Sofosbuvir | Asegua Therapeutics LLC | NDA AUTHORIZED GENERIC | Current |