Application 215515
- Type
- NDA
- Sponsor
- ALNYLAM PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AMVUTTRA | VUTRISIRAN | INJECTABLE;SUBCUTANEOUS | 25MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 71336-1003 | AMVUTTRA | VUTRISIRAN | Alnylam Pharmaceuticals, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81732 | SUPPL | 2025-03-26 |
| 81679 | SUPPL | 2025-03-24 |
| 81574 | SUPPL | 2025-03-14 |
| 81548 | SUPPL | 2025-03-13 |
| 73550 | SUPPL | 2023-02-17 |
| 73545 | SUPPL | 2023-02-17 |
| 71538 | ORIG | 2022-07-12 |
| 71306 | ORIG | 2022-06-14 |
| 71292 | ORIG | 2022-06-14 |