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 2026-06-01
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# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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