Application 214429
- Type
- NDA
- Sponsor
- DRUGS FOR NEGLECTED DISEASES INITIATIVE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FEXINIDAZOLE | FEXINIDAZOLE | TABLET;ORAL | 600MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0024-4512 | Fexinidazole | Fexinidazole | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-4512 | Fexinidazole | Fexinidazole | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-4512 | Fexinidazole | Fexinidazole | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-4512 | Fexinidazole | Fexinidazole | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-4512 | Fexinidazole | Fexinidazole | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-4512 | Fexinidazole | Fexinidazole | Sanofi-Aventis U.S. LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 79719 | SUPPL | 2024-09-24 |
| 79718 | SUPPL | 2024-09-24 |
| 79702 | SUPPL | 2024-09-23 |
| 79701 | SUPPL | 2024-09-23 |
| 69706 | SUPPL | 2021-12-21 |
| 69616 | SUPPL | 2021-12-17 |
| 68341 | ORIG | 2021-08-11 |
| 68136 | ORIG | 2021-07-20 |
| 68113 | ORIG | 2021-07-19 |