Home Applications 761312 Application 761312
Type BLA
Sponsor CITIUS PHARMS Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761312 Lymphir denileukin diftitox-cxdl 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LYMPHIR DENILEUKIN DIFTITOX-CXDL INJECTABLE;INJECTION 300MCG No No
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 ยท 1 matching rows.
Brand, Generic, Manufacturer table 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 Exact identifier application number: BLA761312
Documents# Document, Submission type, Date table Document Submission type Date 82913 ORIG 2025-07-23 79354 ORIG 2024-08-09 79344 ORIG 2024-08-08