GRANIX
These highlights do not include all the information needed to use GRANIX safely and effectively. See full prescribing information for GRANIX.GRANIX (tbo-filgrastim) injection, for subcutaneous use Initial U.S. Approval: 2012
Approved
Approval ID
df918ec2-0907-443f-a52a-b72866959644
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2023
Manufacturers
FDA
Cephalon, LLC
DUNS: 183236314
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tbo-filgrastim
PRODUCT DETAILS
NDC Product Code63459-910
Application NumberBLA125294
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 30, 2023
Generic Nametbo-filgrastim
INGREDIENTS (6)
FILGRASTIMActive
Quantity: 300 ug in 0.5 mL
Code: PVI5M0M1GW
Classification: ACTIB
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
tbo-filgrastim
PRODUCT DETAILS
NDC Product Code63459-918
Application NumberBLA125294
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 30, 2023
Generic Nametbo-filgrastim
INGREDIENTS (6)
FILGRASTIMActive
Quantity: 300 ug in 1 mL
Code: PVI5M0M1GW
Classification: ACTIB
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
tbo-filgrastim
PRODUCT DETAILS
NDC Product Code63459-912
Application NumberBLA125294
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 30, 2023
Generic Nametbo-filgrastim
INGREDIENTS (6)
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
FILGRASTIMActive
Quantity: 480 ug in 0.8 mL
Code: PVI5M0M1GW
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
tbo-filgrastim
PRODUCT DETAILS
NDC Product Code63459-920
Application NumberBLA125294
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 30, 2023
Generic Nametbo-filgrastim
INGREDIENTS (6)
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FILGRASTIMActive
Quantity: 480 ug in 1.6 mL
Code: PVI5M0M1GW
Classification: ACTIB
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT