Home Applications 103293 Application 103293
Type BLA
Sponsor CHIRON Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103293 Proleukin aldesleukin 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PROLEUKIN ALDESLEUKIN VIAL 22MIU/VIAL 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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PROLEUKIN ALDESLEUKIN Iovance Biotherapeutics, Inc f3c516ad-d405-4fbe-af6a-962080dbfa7d 2024-12-20 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA103293
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 65483-116 Proleukin aldesleukin Prometheus Laboratories Inc. BLA Current 65483-116 Proleukin aldesleukin Prometheus Laboratories Inc. BLA Current 76310-022 Proleukin aldesleukin Clinigen Group PLC BLA Current 76310-022 Proleukin aldesleukin Clinigen Group PLC BLA Current 76310-022 Proleukin aldesleukin Clinigen Group PLC BLA Current 76310-022 Proleukin aldesleukin Clinigen Limited BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 75648 SUPPL 2023-10-03 75636 SUPPL 2023-10-02 58782 SUPPL 2019-05-20 31578 SUPPL 2012-08-01 39645 SUPPL 2012-07-30 9381 SUPPL 2012-01-05 9380 SUPPL 2011-08-02 43268 SUPPL 2004-03-26 9379 SUPPL 2004-03-26