Home Applications 208157 Application 208157
Type BLA
Sponsor BAXTER HLTHCARE CORP Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 208157 Myxredlin insulin human 351(a) Rx 2026-08-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MYXREDLIN INSULIN HUMAN SOLUTION;INTRAVENOUS 100 UNITS/100ML (1 UNIT/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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0338-0126 MYXREDLIN insulin human Baxter Healthcare Corporation BLA Current 0338-0126 MYXREDLIN insulin human Baxter Healthcare Corporation BLA Current 0338-0126 MYXREDLIN insulin human Baxter Healthcare Corporation BLA Current 0338-0126 MYXREDLIN insulin human Baxter Healthcare Corporation BLA Current 0338-0126 MYXREDLIN insulin human Baxter Healthcare Corporation NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 81519 SUPPL 2025-03-11 81509 SUPPL 2025-03-11 63422 SUPPL 2020-06-05 62458 APPL 2020-04-07 61584 ORIG 2020-03-23 59157 ORIG 2020-03-23 59144 ORIG 2020-03-23