FDA.reportPublic FDA data

Application 208157

Type
BLA
Sponsor
BAXTER HLTHCARE CORP

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
208157Myxredlininsulin human351(a)Rx2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MYXREDLININSULIN HUMANSOLUTION;INTRAVENOUS100 UNITS/100ML (1 UNIT/ML)NoNo

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MYXREDLININSULIN HUMANBaxter Healthcare Corporationafca6e80-a802-49fb-a978-5fe28a1730012025-03-07Warnings, Adverse reactionsExact identifier
application number: BLA208157
ndc (product): 0338-0126

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0126MYXREDLINinsulin humanBaxter Healthcare CorporationBLACurrent
0338-0126MYXREDLINinsulin humanBaxter Healthcare CorporationBLACurrent
0338-0126MYXREDLINinsulin humanBaxter Healthcare CorporationBLACurrent
0338-0126MYXREDLINinsulin humanBaxter Healthcare CorporationBLACurrent
0338-0126MYXREDLINinsulin humanBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81519SUPPL 2025-03-11
81509SUPPL 2025-03-11
63422SUPPL2020-06-05
62458APPL2020-04-07
61584ORIG2020-03-23
59157ORIG2020-03-23
59144ORIG2020-03-23