FDA.reportPublic FDA data

Application 761080

Type
BLA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NIVESTYMFILGRASTIM-AAFIVIAL;SINGLE-DOSE300MCG/MLNoNo
002NIVESTYMFILGRASTIM-AAFIVIAL;SINGLE-DOSE480MCG/1.6MLNoNo
003NIVESTYMFILGRASTIM-AAFIINJECTABLE;INJECTION300MCG/0.5MLNoNo
004NIVESTYMFILGRASTIM-AAFIINJECTABLE;INJECTION480MCG/0.8MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0291Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0291Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0291Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0291Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0291Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0291Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0291Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0291Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0291Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0292Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0292Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0292Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0292Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0292Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0292Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0292Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0292Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0292Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0293Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0293Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0293Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0293Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0293Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0293Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0293Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0293Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0293Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0294Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0294Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0294Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0294Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0294Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0294Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0294Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0294Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent
0069-0294Nivestymfilgrastim-aafiPfizer Laboratories Div Pfizer IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77584SUPPL 2024-02-20
77583SUPPL 2024-02-20
75317SUPPL 2023-08-29
75315SUPPL 2023-08-28
67439SUPPL2021-05-07
67397SUPPL2021-05-04
57738ORIG2019-02-21
54949ORIG2018-07-23
54938ORIG2018-07-20
63002ORIG1900-01-01
63001ORIG1900-01-01
63000ORIG1900-01-01
62999ORIG1900-01-01