Application 212480
- Type
- NDA
- Sponsor
- GILEAD SCIENCES INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SOVALDI | SOFOSBUVIR | PELLETS;ORAL | 150MG/PACKET | Yes | No |
| 002 | SOVALDI | SOFOSBUVIR | PELLETS;ORAL | 200MG/PACKET | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 61958-1504 | Sovaldi | SOFOSBUVIR | Gilead Sciences, Inc. | NDA | Current |
| 61958-1504 | Sovaldi | SOFOSBUVIR | Gilead Sciences, Inc. | NDA | Current |
| 61958-1504 | Sovaldi | SOFOSBUVIR | Gilead Sciences, Inc. | NDA | Current |
| 61958-1504 | Sovaldi | SOFOSBUVIR | Gilead Sciences, Inc. | NDA | Current |
| 61958-1505 | Sovaldi | SOFOSBUVIR | Gilead Sciences, Inc. | NDA | Current |
| 61958-1505 | Sovaldi | SOFOSBUVIR | Gilead Sciences, Inc. | NDA | Current |
| 61958-1505 | Sovaldi | SOFOSBUVIR | Gilead Sciences, Inc. | NDA | Current |
| 61958-1505 | Sovaldi | SOFOSBUVIR | Gilead Sciences, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 80749 | SUPPL | 2024-12-27 |
| 80743 | SUPPL | 2024-12-27 |
| 62299 | ORIG | 2020-03-24 |
| 62077 | SUPPL | 2020-03-06 |
| 62061 | SUPPL | 2020-03-06 |
| 61159 | SUPPL | 2019-12-05 |
| 60067 | SUPPL | 2019-09-20 |
| 60064 | SUPPL | 2019-09-20 |
| 59888 | ORIG | 2019-08-30 |
| 59873 | ORIG | 2019-08-29 |