Application 761188
- Type
- BLA
- Sponsor
- BIOCON BIOLOGICS INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761188 | Kirsty | insulin aspart-xjhz | 351(k) Interchangeable | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KIRSTY | INSULIN ASPART-XJHZ | INJECTION;SOLUTION | 100 UNITS/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 |
|---|---|---|---|---|---|---|
| INSULIN DILUTING MEDIUM FOR Kirsty | WATER | Biocon Biologics Inc. | 3db1d482-7e1f-aec6-79ef-3f305b4d8277 | 2026-01-20 | Warnings, Adverse reactions | BLA761188 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.