Home Applications 125277 Application 125277
Type BLA
Sponsor DYAX CORP. Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125277 Kalbitor ecallantide 351(a) Rx 2026-09-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KALBITOR ECALLANTIDE INJECTABLE; INJECTION 10MG/ML 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 Kalbitor ECALLANTIDE Takeda Pharmaceuticals America, Inc. f56aec67-c662-477c-b866-bfc23e8809cf 2025-07-01 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125277 ndc (product): 47783-101
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 47783-101 Kalbitor Ecallantide Takeda Pharmaceuticals America, Inc. BLA Current 47783-101 KALBITOR ECALLANTIDE Dyax Corp. BLA Current 47783-101 Kalbitor Ecallantide Takeda Pharmaceuticals America, Inc. BLA Current 47783-101 KALBITOR ECALLANTIDE Dyax Corp. BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 65778 SUPPL 2020-12-29 65773 SUPPL 2020-12-28 65772 SUPPL 2020-12-28 9672 SUPPL 2014-09-10 39894 SUPPL 2014-09-09 9671 SUPPL 2014-04-02 18843 SUPPL 2014-04-01 9670 SUPPL 2013-04-16 9669 SUPPL 2012-04-27 9668 SUPPL 2011-09-13 9667 SUPPL 2011-05-17 44796 ORIG 2010-02-14 43314 ORIG 2010-02-14 9666 ORIG 2009-12-08 39893 ORIG 2009-12-02 23459 ORIG 2009-12-02