FDA.reportPublic FDA data

Application 761334

Type
BLA
Sponsor
INCYTE CORP

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761334Zynyzretifanlimab-dlwr351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZYNYZRETIFANLIMAB-DLWRINJECTABLE;INTRAVENOUS500MG/20ML(25MG/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 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZYNYZRETIFANLIMAB-DLWRIncyte Corporation109648d0-d30a-42fc-8273-39cb1540a7512026-05-18Warnings, Adverse reactionsExact identifier
application number: BLA761334

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85984SUPPL 2026-05-19
85980SUPPL 2026-05-19
85612SUPPL 2026-03-31
85610SUPPL 2026-03-31
85662SUPPL 2026-03-30
84485SUPPL 2025-12-22
84463SUPPL 2025-12-19
82306SUPPL 2025-05-23
82239SUPPL 2025-05-15
78245SUPPL 2024-04-25
78241SUPPL 2024-04-24
74015ORIG 2023-04-19
73826ORIG 2023-03-23
73815ORIG 2023-03-22
73814ORIG 2023-03-22