FDA.reportPublic FDA data

Application 761039

Type
BLA
Sponsor
COHERUS BIOSCIENCES INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001UDENYCAPEGFILGRASTIM-CBQVINJECTABLE;INJECTION6MG/0.6MLNoNo

NDC Listings For This Application#

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