Application 212194
- Type
- NDA
- Sponsor
- ALNYLAM PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GIVLAARI | GIVOSIRAN SODIUM | SOLUTION;SUBCUTANEOUS | EQ 189MG BASE/ML (EQ 189MG BASE/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 71336-1001 | GIVLAARI | givosiran sodium | Alnylam Pharmaceuticals, Inc. | NDA | Current |
| 71336-1001 | GIVLAARI | givosiran sodium | Alnylam Pharmaceuticals, Inc. | NDA | Current |
| 71336-1001 | GIVLAARI | givosiran sodium | Alnylam Pharmaceuticals, Inc. | NDA | Current |
| 71336-1001 | GIVLAARI | givosiran sodium | Alnylam Pharmaceuticals, Inc. | NDA | Current |
| 71336-1001 | GIVLAARI | givosiran sodium | Alnylam Pharmaceuticals, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 78320 | SUPPL | 2024-04-30 |
| 78307 | SUPPL | 2024-04-30 |
| 73497 | SUPPL | 2023-02-14 |
| 73472 | SUPPL | 2023-02-13 |
| 69176 | SUPPL | 2021-10-29 |
| 69154 | SUPPL | 2021-10-29 |
| 61248 | ORIG | 2019-12-12 |
| 61018 | ORIG | 2019-11-22 |
| 60994 | ORIG | 2019-11-20 |