Home Applications 125103 Application 125103
Type BLA
Sponsor BIOVITRUM AB Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125103 Kepivance palifermin 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KEPIVANCE PALIFERMIN INJECTABLE; INJECTION 60MCG/KG/DAY 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 KEPIVANCE PALIFERMIN Swedish Orphan Biovitrum AB (publ) 426f6e64-2c20-4a61-6d65-7320426f6e64 2025-12-17 Warnings, Adverse reactions Exact identifier application number: BLA125103
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 66658-112 Kepivance palifermin Swedish Orphan Biovitrum AB (publ) BLA Current 66658-112 Kepivance palifermin Swedish Orphan Biovitrum AB (publ) BLA Current 66658-112 Kepivance palifermin Swedish Orphan Biovitrum AB (publ) BLA Current