Skip to contentApplication 213036
- Type
- NDA
- Sponsor
- AMIVAS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ARTESUNATE | ARTESUNATE | POWDER;INTRAVENOUS | 110MG/VIAL | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 73607-001 | Artesunate | Artesunate | Amivas, LLC | NDA | Current |
| 73607-001 | Artesunate | Artesunate | Amivas, LLC | NDA | Current |
| 73607-011 | Artesunate | Artesunate | Amivas, LLC | NDA | Current |
| 73607-011 | Artesunate | Artesunate | Amivas, LLC | NDA | Current |
| 73607-011 | Artesunate | Artesunate | Amivas, LLC | NDA | Current |
| 73607-011 | Artesunate | Artesunate | Amivas, Inc | NDA | Current |
| 73607-011 | Artesunate | Artesunate | Amivas, Inc | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85682 | SUPPL | 2026-04-15 |
| 80875 | SUPPL | 2025-01-21 |
| 80870 | SUPPL | 2025-01-17 |
| 74967 | SUPPL | 2023-08-01 |
| 74966 | SUPPL | 2023-08-01 |
| 73692 | SUPPL | 2023-03-06 |
| 73678 | SUPPL | 2023-03-06 |
| 70105 | SUPPL | 2022-02-07 |
| 70104 | SUPPL | 2022-02-07 |
| 63706 | ORIG | 2020-06-25 |
| 63309 | ORIG | 2020-05-27 |
| 63301 | ORIG | 2020-05-27 |