Application 761196
- Type
- BLA
- Sponsor
- ADC Therapeutics SA
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761196 | Zynlonta | loncastuximab tesirine-lpyl | 351(a) | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZYNLONTA | LONCASTUXIMAB TESIRINE-LPYL | INJECTABLE;INJECTION | 10MG | 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 |
|---|---|---|---|---|---|---|
| ZYNLONTA | LONCASTUXIMAB TESIRINE | ADC Therapeutics America, Inc. | af54af12-3edf-4301-8bc5-0446bc813c1d | 2026-06-12 | Warnings, Adverse reactions | BLA761196 79952-110 |
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 |
|---|---|---|---|---|---|
| 79952-110 | ZYNLONTA | loncastuximab tesirine | ADC Therapeutics America, Inc. | BLA | Current |
| 79952-110 | ZYNLONTA | loncastuximab tesirine | ADC Therapeutics America, Inc. | BLA | Current |
| 79952-110 | ZYNLONTA | loncastuximab tesirine | ADC Therapeutics America, Inc. | BLA | Current |
| 79952-110 | ZYNLONTA | loncastuximab tesirine | ADC Therapeutics America, Inc. | BLA | Current |
| 79952-110 | ZYNLONTA | loncastuximab tesirine | ADC Therapeutics America, Inc. | BLA | Current |
| 79952-110 | ZYNLONTA | loncastuximab tesirine | ADC Therapeutics America, Inc. | BLA | Current |