Application 215833
- Type
- NDA
- Sponsor
- ADVANCED ACCELERATOR APPLICATIONS USA INC A NOVART
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PLUVICTO | LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN | INJECTABLE;INJECTION | 1000 MBQ/ML (27MCI/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69488-010 | PLUVICTO | lutetium Lu 177 vipivotide tetraxetan | Advanced Accelerator Applications USA, Inc | NDA | Current |
| 69488-010 | PLUVICTO | lutetium Lu 177 vipivotide tetraxetan | Advanced Accelerator Applications USA, Inc | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85667 | SUPPL | 2026-04-10 |
| 85656 | SUPPL | 2026-04-09 |
| 81782 | SUPPL | 2026-03-02 |
| 81781 | SUPPL | 2026-03-02 |
| 81897 | SUPPL | 2025-04-09 |
| 81896 | SUPPL | 2025-04-09 |
| 70788 | ORIG | 2022-04-19 |
| 70596 | ORIG | 2022-03-24 |
| 70591 | ORIG | 2022-03-23 |