Home Applications 125293 Application 125293
Type BLA
Sponsor HORIZON PHARMA Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125293 Krystexxa pegloticase 351(a) Rx 2026-08-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KRYSTEXXA PEGLOTICASE INJECTABLE; INJECTION 8MG Yes 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 Krystexxa PEGLOTICASE Horizon Therapeutics USA, Inc. 6e566303-d93a-4130-b764-25749829aa95 2026-07-09 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125293 ndc (product): 75987-080
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 54396-801 Krystexxa pegloticase Savient Pharmaceuticals, Inc. BLA Current 60809-801 Krystexxa pegloticase Horizon Pharma Inc. BLA Current 75987-080 Krystexxa pegloticase Horizon Therapeutics USA, Inc. BLA Current 75987-080 Krystexxa pegloticase Horizon Therapeutics USA, Inc. BLA Current 75987-080 Krystexxa pegloticase Horizon Therapeutics USA, Inc. BLA Current 75987-080 Krystexxa pegloticase Horizon Therapeutics USA, Inc. BLA Current 75987-080 Krystexxa pegloticase Horizon Pharma Inc. BLA Current 75987-080 Krystexxa pegloticase Horizon Therapeutics USA, Inc. BLA Current 75987-080 Krystexxa pegloticase Horizon Therapeutics USA, Inc. BLA Current