FDA.reportPublic FDA data

Application 761082

Type
BLA
Sponsor
KASHIV BIOSCIENCES LLC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761082Releukofilgrastim-ayow351(k) BiosimilarRx2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RELEUKOFILGRASTIM-AYOWINJECTABLE;INJECTION300MCG/MLNoNo
002RELEUKOFILGRASTIM-AYOWSOLUTION;SUBCUTANEOUS480MCG/0.8 ML/VIALNoNo
003RELEUKOFILGRASTIM-AYOWSOLUTION;INTRAVENOUS, SUBCUTANEOUS300MCG/MLNoNo
004RELEUKOFILGRASTIM-AYOWSOLUTION;INTRAVENOUS, SUBCUTANEOUS480MCG/1.6MLNoNo

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
RELEUKOFILGRASTIMAmneal Pharmaceuticals LLC74e1ec6e-1630-4654-895c-2bd355f939e72025-04-24Warnings, Adverse reactionsExact identifier
application number: BLA761082
ndc (product): 70121-1570
ndc (product): 70121-1568
ndc (product): 70121-1571
ndc (product): 70121-1569

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70121-1568RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1568RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1568RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1568RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1568RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1568RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1569RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1569RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1569RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1569RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1569RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1569RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1570RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1570RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1570RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1570RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1570RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1570RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1571RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1571RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1571RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1571RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1571RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent
70121-1571RELEUKOFilgrastimAmneal Pharmaceuticals LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82138SUPPL 2025-05-05
82077SUPPL 2025-04-30
75356SUPPL 2023-09-05
75352SUPPL 2023-09-05
72522SUPPL2022-11-01
72507SUPPL2022-10-31
70736ORIG2022-04-11
70709ORIG2022-04-06
70293ORIG2022-02-28
70283ORIG2022-02-28