FDA.reportPublic FDA data

Application 761116

Type
BLA
Sponsor
STEMLINE THERAPEUTICS INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761116Elzonristagraxofusp-erzs351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELZONRISTAGRAXOFUSP-ERZSSOLUTION;INJECTION1000MCGNoNo

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ElzonrisTAGRAXOFUSPStemline Therapeutics, Inc.80eb1080-fe20-4af0-b2a5-a67999923fa82024-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761116
ndc (product): 72187-0401

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
72187-0401ElzonristagraxofuspStemline Therapeutics, Inc.BLACurrent
72187-0401ElzonristagraxofuspStemline Therapeutics, Inc.BLACurrent
72187-0401ElzonristagraxofuspStemline Therapeutics, Inc.BLACurrent
72187-0401ElzonristagraxofuspStemline Therapeutics, Inc.BLACurrent
72187-0401ElzonristagraxofuspStemline Therapeutics, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74909SUPPL 2023-07-27
74901SUPPL 2023-07-27
72570SUPPL2022-11-07
72559SUPPL2022-11-04
72494SUPPL2022-10-28
72491SUPPL2022-10-28
57350ORIG2019-01-28
56969ORIG2018-12-21