FDA.reportPublic FDA data

Application 761084

Type
BLA
Sponsor
KASHIV BIOSCIENCES LLC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761084Fylnetrapegfilgrastim-pbbk351(k) BiosimilarRx2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FYLNETRAPEGFILGRASTIM-PBBKINJECTABLE;INJECTION6MG/0.6MLNoNo

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
FYLNETRAPEGFILGRASTIMAmneal Pharmaceuticals LLCeeadd641-573d-47fe-897a-61006e5f9e032025-04-25Warnings, Adverse reactionsExact identifier
application number: BLA761084
ndc (product): 70121-1627

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70121-1627FYLNETRApegfilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1627FYLNETRApegfilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1627FYLNETRApegfilgrastimAmneal Pharmaceuticals LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82094SUPPL 2025-05-01
81982SUPPL 2025-04-24
71555ORIG2022-07-15
71231ORIG2022-06-07
71155ORIG2022-05-26