Application 216142
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE CORP
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MICAFUNGIN IN SODIUM CHLORIDE 0.9% | MICAFUNGIN SODIUM | SOLUTION;INTRAVENOUS | EQ 50MG BASE/50ML (EQ 1MG BASE/ML) | Yes | Yes |
| 002 | MICAFUNGIN IN SODIUM CHLORIDE 0.9% | MICAFUNGIN SODIUM | SOLUTION;INTRAVENOUS | EQ 100MG BASE/100ML (EQ 1MG BASE/ML) | Yes | Yes |
| 003 | MICAFUNGIN IN SODIUM CHLORIDE 0.9% | MICAFUNGIN SODIUM | SOLUTION;INTRAVENOUS | EQ 150MG BASE/150ML (EQ 1MG BASE/ML) | Yes | Yes |
Documents
| Document | Submission type | Date |
|---|
| 77427 | ORIG | 2024-02-08 |
| 75663 | ORIG | 2023-10-03 |
| 75661 | ORIG | 2023-10-03 |