Application 125151
- Type
- BLA
- Sponsor
- SHIRE
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 125151 | Elaprase | idursulfase | 351(a) | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ELAPRASE | IDURSULFASE | INJECTABLE; IV (INFUSION) | 6MG/3ML | 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 |
|---|---|---|---|---|---|---|
| ELAPRASE | IDURSULFASE | Takeda Pharmaceuticals America, Inc. | 60cba843-5aab-4dd7-96dc-66648d413be3 | 2025-04-15 | Boxed warning, Warnings, Adverse reactions | BLA125151 54092-700 |
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 |
|---|---|---|---|---|---|
| 54092-700 | ELAPRASE | idursulfase | Takeda Pharmaceuticals America, Inc. | BLA | Current |
| 54092-700 | ELAPRASE | idursulfase | Takeda Pharmaceuticals America, Inc. | BLA | Current |
| 54092-700 | ELAPRASE | idursulfase | Takeda Pharmaceuticals America, Inc. | BLA | Current |
| 54092-700 | ELAPRASE | idursulfase | Shire US Manufacturing Inc. | BLA | Current |