Skip to contentApplication 215973
- Type
- NDA
- Sponsor
- GILEAD SCIENCES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SUNLENCA | LENACAPAVIR | INJECTABLE;INJECTION | 300MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 61958-3002 | Sunlenca | LENACAPAVIR SODIUM | Gilead Sciences | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85378 | SUPPL | 2026-03-16 |
| 80434 | SUPPL | 2024-11-26 |
| 80420 | SUPPL | 2024-11-26 |
| 79137 | SUPPL | 2024-07-22 |
| 79116 | SUPPL | 2024-07-18 |
| 73383 | ORIG | 2023-02-06 |
| 73028 | ORIG | 2022-12-23 |
| 73001 | ORIG | 2022-12-22 |