FDA.reportPublic FDA data

Application 761039

Type
BLA
Sponsor
COHERUS BIOSCIENCES INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761039Udenycapegfilgrastim-cbqv351(k) BiosimilarRx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001UDENYCAPEGFILGRASTIM-CBQVINJECTABLE;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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UDENYCAPEGFILGRASTIM-CBQVAccord BioPharma, Inc.77a8576f-b91e-42ce-b613-2fa3c3d4a5712026-04-23Warnings, Adverse reactionsExact identifier
application number: BLA761039
UDENYCAPEGFILGRASTIM-CBQVCoherus Oncology, Inc.a8c290ee-b699-4395-a596-1453d4a4b4eb2025-08-14Warnings, Adverse reactionsExact identifier
application number: BLA761039
ndc (product): 70114-101

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70114-101UDENYCApegfilgrastim-cbqvCoherus BioSciences IncBLACurrent
70114-101UDENYCApegfilgrastim-cbqvCoherus BioSciences IncBLACurrent
70114-101UDENYCApegfilgrastim-cbqvCoherus BioSciences IncBLACurrent
70114-101UDENYCApegfilgrastim-cbqvCoherus BioSciences IncBLACurrent
70114-101UDENYCApegfilgrastim-cbqvCoherus BioSciences IncBLACurrent
70114-101UDENYCApegfilgrastim-cbqvCoherus BioSciences IncBLACurrent
70114-101UDENYCApegfilgrastim-cbqvCoherus BioSciences IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77135SUPPL 2023-12-27
77126SUPPL 2023-12-22
73677SUPPL 2023-03-06
73676SUPPL 2023-03-06
72749SUPPL2022-11-29
72748SUPPL2022-11-29
67742SUPPL2021-06-08
67733SUPPL2021-06-08
61886SUPPL2020-02-13
61877SUPPL2020-02-13
60593SUPPL2020-01-28
60592SUPPL2019-10-21
56409ORIG2019-10-21
58345SUPPL2019-04-18
57906ORIG2019-03-05
56250ORIG2018-11-02
63219ORIG1900-01-01
63217ORIG1900-01-01
63216ORIG1900-01-01