Application 761325
- Type
- BLA
- Sponsor
- SANOFI-AVENTIS U.S. LLC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761325 | Merilog | insulin aspart-szjj | 351(k) Biosimilar | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MERILOG | INSULIN ASPART-SZJJ | INJECTION;SOLUTION | 10ML(100UNITS/ML) | No | No |
| 002 | MERILOG SOLOSTAR | INSULIN ASPART-SZJJ | INJECTION;SOLUTION | 3ML(100UNITS/ML) | 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 |
|---|---|---|---|---|---|---|
| MERILOG | INSULIN ASPART-SZJJ | Sanofi-Aventis U.S. LLC | eee07a52-1102-4d48-9782-26061db175ad | 2025-10-07 | Warnings, Adverse reactions | BLA761325 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.