Application 125349
- Type
- BLA
- Sponsor
- HUMAN GENOME SCIENCES INC.
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125349 | | raxibacumab | 351(a) | Rx | 2026-09-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RAXIBACUMAB | RAXIBACUMAB | INJECTABLE; IV (INFUSION) | 1700MG/34ML (50MG/ML) | Yes | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 3 matching rows.
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 49401-103 | Raxibacumab | raxibacumab | Human Genome Sciences, Inc. | BLA | Current |
| 71655-103 | Raxibacumab | raxibacumab | Emergent Manufacturing Operations Baltimore LLC | BLA | Current |
| 71655-103 | Raxibacumab | raxibacumab | Emergent Manufacturing Operations Baltimore LLC | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 67687 | SUPPL | 2021-06-03 |
| 67678 | SUPPL | 2021-06-03 |
| 67677 | SUPPL | 2021-06-03 |
| 51073 | SUPPL | 2018-01-17 |
| 44803 | ORIG | 2013-01-25 |
| 22803 | ORIG | 2013-01-25 |
| 18880 | ORIG | 2012-12-27 |
| 9715 | ORIG | 2012-12-27 |