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)Rx2026-06-01

Application Products#

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

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
BESREMiROPEGINTERFERON ALFA-2BPharmaEssentia USA9583405d-53a0-49dc-88eb-5e6384ebabcb2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761166
ndc (product): 73536-500

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