Application 214103
- Type
- NDA
- Sponsor
- ALNYLAM PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OXLUMO | LUMASIRAN | SOLUTION;SUBCUTANEOUS | 94.5MG/0.5ML | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 71336-1002 | OXLUMO | lumasiran | Alnylam Pharmaceuticals, Inc. | NDA | Current |
| 71336-1002 | OXLUMO | lumasiran | Alnylam Pharmaceuticals, Inc. | NDA | Current |
| 71336-1002 | OXLUMO | lumasiran | Alnylam Pharmaceuticals, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81886 | SUPPL | 2025-04-08 |
| 81832 | SUPPL | 2025-04-07 |
| 75527 | SUPPL | 2023-09-21 |
| 75521 | SUPPL | 2023-09-20 |
| 72281 | SUPPL | 2022-10-11 |
| 72270 | SUPPL | 2022-10-07 |
| 65662 | ORIG | 2020-12-21 |
| 65531 | ORIG | 2020-12-08 |
| 65349 | ORIG | 2020-11-25 |