FDA.reportPublic FDA data

Application 761111

Type
BLA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NYVEPRIAPEGFILGRASTIM-APGFINJECTABLE;INJECTION6MG/0.6MLNoNo

NDC Listings For This Application#

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