Application 125509
- Type
- BLA
- Sponsor
- ELUSYS THERAPEUTICS INC
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125509 | Anthim | obiltoxaximab | 351(a) | Rx | 2026-09-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ANTHIM | OBILTOXAXIMAB | INJECTABLE;INJECTION | 600MG/6ML | No | 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 5 matching rows.
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69604-204 | Anthim | obiltoxaximab | Elusys Therapeutics, Inc. | BLA | Current |
| 69604-204 | Anthim | obiltoxaximab | Elusys Therapeutics, Inc. | BLA | Current |
| 69604-204 | Anthim | obiltoxaximab | Elusys Therapeutics, Inc. | BLA | Current |
| 69604-204 | Anthim | obiltoxaximab | Elusys Therapeutics, Inc. | BLA | Current |
| 69604-204 | Anthim | obiltoxaximab | Elusys Therapeutics, Inc. | BLA | Current |