Application 213464
- Type
- NDA
- Sponsor
- BAYER HEALTHCARE PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LAMPIT | NIFURTIMOX | TABLET;ORAL | 30MG | No | No |
| 002 | LAMPIT | NIFURTIMOX | TABLET;ORAL | 120MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50419-750 | LAMPIT | nifurtimox | Bayer Healthcare Pharmaceuticals INC. | NDA | Current |
| 50419-750 | LAMPIT | nifurtimox | Bayer Healthcare Pharmaceuticals INC. | NDA | Current |
| 50419-750 | LAMPIT | nifurtimox | Bayer Healthcare Pharmaceuticals INC. | NDA | Current |
| 50419-750 | LAMPIT | nifurtimox | Bayer Healthcare Pharmaceuticals INC. | NDA | Current |
| 50419-751 | LAMPIT | nifurtimox | Bayer Healthcare Pharmaceuticals INC. | NDA | Current |
| 50419-751 | LAMPIT | nifurtimox | Bayer Healthcare Pharmaceuticals INC. | NDA | Current |
| 50419-751 | LAMPIT | nifurtimox | Bayer Healthcare Pharmaceuticals INC. | NDA | Current |
| 50419-751 | LAMPIT | nifurtimox | Bayer Healthcare Pharmaceuticals INC. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 74427 | SUPPL | 2023-06-06 |
| 74432 | SUPPL | 2023-06-05 |
| 73598 | SUPPL | 2023-02-23 |
| 73597 | SUPPL | 2023-02-23 |
| 70025 | SUPPL | 2022-02-01 |
| 70003 | SUPPL | 2022-01-31 |
| 64873 | SUPPL | 2020-10-07 |
| 64824 | SUPPL | 2020-10-05 |
| 64455 | ORIG | 2020-08-31 |
| 64232 | ORIG | 2020-08-07 |
| 64229 | ORIG | 2020-08-06 |