Skip to contentApplication 204684
- Type
- NDA
- Sponsor
- KNIGHT THERAPS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IMPAVIDO | MILTEFOSINE | CAPSULE;ORAL | 50MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69051-300 | IMPAVIDO | miltefosine | Profounda, Inc. | NDA | Current |
| 69051-300 | IMPAVIDO | miltefosine | Profounda, Inc. | NDA | Current |
| 69051-300 | IMPAVIDO | miltefosine | Profounda, Inc. | NDA | Current |
| 69051-300 | IMPAVIDO | miltefosine | Profounda, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81625 | SUPPL | 2025-03-18 |
| 81624 | SUPPL | 2025-03-18 |
| 81623 | SUPPL | 2025-03-18 |
| 81616 | SUPPL | 2025-03-17 |
| 81615 | SUPPL | 2025-03-17 |
| 81614 | SUPPL | 2025-03-17 |
| 67655 | SUPPL | 2021-06-02 |
| 67596 | SUPPL | 2021-05-26 |
| 22963 | ORIG | 2014-04-18 |
| 10380 | ORIG | 2014-03-21 |
| 40414 | ORIG | 2014-03-20 |