Application 761179
- Type
- BLA
- Sponsor
- JAZZ PHARMS
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761179 | Rylaze | asparaginase erwinia chrysanthemi (recombinant)-rywn | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RYLAZE | ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN | INJECTABLE;INTRAMUSCULAR | 10MG/0.5ML | 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 |
|---|---|---|---|---|---|---|
| Rylaze | ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN | Jazz Pharmaceuticals, Inc. | 857e53aa-1098-4dad-b654-0276cdd43e03 | 2025-07-01 | Warnings, Adverse reactions | BLA761179 68727-900 |
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 |
|---|---|---|---|---|---|
| 68727-900 | Rylaze | asparaginase erwinia chrysanthemi (recombinant)-rywn | Jazz Pharmaceuticals, Inc. | BLA | Current |
| 68727-900 | Rylaze | asparaginase erwinia chrysanthemi (recombinant)-rywn | Jazz Pharmaceuticals, Inc. | BLA | Current |
| 68727-900 | Rylaze | asparaginase erwinia chrysanthemi (recombinant)-rywn | Jazz Pharmaceuticals, Inc. | BLA | Current |
| 68727-900 | Rylaze | asparaginase erwinia chrysanthemi (recombinant)-rywn | Jazz Pharmaceuticals, Inc. | BLA | Current |