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`Drug Details
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`Drug Name(s)
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`FDA Application No.
`
`Active Ingredient(s)
`
`Company
`
`Original Approval or Tentative Approval Date
`
`NEUPOGEN
`
`(BLA) 103353
`
`FI LG RASTI M
`
`AMGEN
`
`February 20, 1991
`
`= There are no Therapeutic Equivalents
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`¯ Label Information
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`¯ Approval History, Letters, Reviews, and
`Related Documents
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`¯ Physician Package Insert 31°
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`¯ Physician Package Insert Part 111
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`Physician Package Insert Part 212
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`Products on App!ication (BLA) #103353
`Click on a column header to re-sort the table:
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`Drug Name Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`NEUPOGEN
`NEUPOGEN
`NEUPOGEN
`NEUPOGEN
`
`FILGRASTIM
`FILGRASTIM
`FILGRASTIM
`FILGRASTIM
`
`300MCG/:IML
`480MCG/1,6ML
`300MGC/0.5ML
`480MCG/0,8ML
`
`VIAL
`VIAL
`SYRINGE
`SYRINGE
`
`Marketing
`Status
`Prescription
`Prescription
`Prescription
`Prescription
`
`RLD TE
`Code
`None
`None
`None
`None
`
`No
`No
`No
`No
`
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`Sandozlnc. IPR2016-00318
`Sandoz v. Eli Lilly, Exhibitl071-0001
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`
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`Drugs@FDA: FDA Approved Drug Products
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`Sandoz Inc. IPR2016-00318
`Sandoz v. Eli Lilly, Exhibit 1071-0002