Application 761312
- Type
- BLA
- Sponsor
- CITIUS PHARMS
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761312 | Lymphir | denileukin diftitox-cxdl | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LYMPHIR | DENILEUKIN DIFTITOX-CXDL | INJECTABLE;INJECTION | 300MCG | 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 |
|---|---|---|---|---|---|---|
| LYMPHIR | DENILEUKIN DIFTITOX-CXDL | Citius Pharmaceuticals, Inc. | ac3613d7-4304-40e7-a3f5-adb8a8adca5d | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | BLA761312 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.