Application 761196
- Type
- BLA
- Sponsor
- ADC Therapeutics SA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZYNLONTA | LONCASTUXIMAB TESIRINE-LPYL | INJECTABLE;INJECTION | 10MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85144 | SUPPL | 2026-02-24 |
| 85115 | SUPPL | 2026-02-24 |
| 84814 | SUPPL | 2026-01-22 |
| 84802 | SUPPL | 2026-01-21 |
| 72398 | SUPPL | 2022-10-17 |
| 72397 | SUPPL | 2022-10-17 |
| 72317 | SUPPL | 2022-10-13 |
| 72316 | SUPPL | 2022-10-13 |
| 67576 | ORIG | 2021-05-24 |
| 67180 | ORIG | 2021-04-27 |
| 67161 | ORIG | 2021-04-23 |