FDA.reportPublic FDA data

Application 761166

Type
BLA
Sponsor
PHARMAESSENTIA CORP

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761166Besremiropeginterferon alfa-2b-njft351(a)Rx2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BESREMIROPEGINTERFERON ALFA-2B-NJFTINJECTABLE;SUBCUTANEOUS500 MCG/MLNoNo

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
BESREMiROPEGINTERFERON ALFA-2BPharmaEssentia USA9583405d-53a0-49dc-88eb-5e6384ebabcb2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761166
ndc (product): 73536-500

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
73536-500BESREMiROPEGINTERFERON ALFA-2BPharmaEssentia USABLACurrent
73536-500BESREMiROPEGINTERFERON ALFA-2BPharmaEssentia USABLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78317SUPPL 2024-04-30
78316SUPPL 2024-04-30
78309SUPPL 2024-04-30
69541ORIG2021-12-13
69318ORIG2021-11-16
69314ORIG2021-11-15
69313ORIG2021-11-15