Application 761025
- Type
- BLA
- Sponsor
- BOEHRINGER INGELHEIM
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761025 | Praxbind | idarucizumab | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRAXBIND | IDARUCIZUMAB | INJECTABLE;INJECTION | 2.5G/50ML | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Praxbind | IDARUCIZUMAB | Boehringer Ingelheim Pharmaceuticals, Inc. | c7400f8a-dcf4-a6df-6d07-983081b1bf34 | 2024-01-23 | Warnings, Adverse reactions | BLA761025 0597-0197 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0597-0197 | Praxbind | idarucizumab | Boehringer Ingelheim Pharmaceuticals, Inc. | BLA | Current |
| 0597-0197 | Praxbind | idarucizumab | Boehringer Ingelheim Pharmaceuticals, Inc. | BLA | Current |
| 0597-0197 | Praxbind | idarucizumab | Boehringer Ingelheim Pharmaceuticals, Inc. | BLA | Current |