FDA.reportPublic FDA data

Application 761111

Type
BLA
Sponsor
HOSPIRA INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761111Nyvepriapegfilgrastim-apgf351(k) BiosimilarRx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NYVEPRIAPEGFILGRASTIM-APGFINJECTABLE;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
NYVEPRIAPEGFILGRASTIM-APGFPfizer Laboratories Div Pfizer Inc99d30b99-2743-446b-98f3-0430bf4ea8692026-06-02Warnings, Adverse reactionsExact identifier
application number: BLA761111
ndc (product): 0069-0324

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0324NYVEPRIApegfilgrastim-apgfPfizer Laboratories Div Pfizer IncBLACurrent
0069-0324NYVEPRIApegfilgrastim-apgfPfizer Laboratories Div Pfizer IncBLACurrent
0069-0324NYVEPRIApegfilgrastim-apgfPfizer Laboratories Div Pfizer IncBLACurrent
0069-0324NYVEPRIApegfilgrastim-apgfPfizer Laboratories Div Pfizer IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67116SUPPL2021-04-19
67098SUPPL2021-04-19
64263ORIG2020-08-11
63491ORIG2020-06-12
63481ORIG2020-06-11