Neupogen
Approved
Approval ID
3bc802bd-76b4-4f45-8571-a436ec26228e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 2, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
filgrastim
PRODUCT DETAILS
NDC Product Code54868-2522
Application NumberBLA103353
Marketing CategoryC73585
Route of AdministrationINTRAVENOUS
Effective DateDecember 2, 2009
Generic Namefilgrastim
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.04 mg in 1.0 mL
Code: 6OZP39ZG8H
Classification: IACT
SODIUM POLYMETAPHOSPHATEInactive
Quantity: 0.035 mg in 1.0 mL
Code: P1BM4ZH95L
Classification: IACT
FILGRASTIMActive
Quantity: 300 ug in 1 mL
Code: PVI5M0M1GW
Classification: ACTIB
SORBITOLInactive
Quantity: 50.0 mg in 1.0 mL
Code: 506T60A25R
Classification: IACT
filgrastim
PRODUCT DETAILS
NDC Product Code54868-3050
Application NumberBLA103353
Marketing CategoryC73585
Route of AdministrationINTRAVENOUS
Effective DateDecember 2, 2009
Generic Namefilgrastim
INGREDIENTS (5)
FILGRASTIMActive
Quantity: 480 ug in 0.8 mL
Code: PVI5M0M1GW
Classification: ACTIB
POLYSORBATE 80Inactive
Quantity: 0.32 mg in 0.8 mL
Code: 6OZP39ZG8H
Classification: IACT
SORBITOLInactive
Quantity: 40.0 mg in 0.8 mL
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM POLYMETAPHOSPHATEInactive
Quantity: 0.028 mg in 0.8 mL
Code: P1BM4ZH95L
Classification: IACT
filgrastim
PRODUCT DETAILS
NDC Product Code54868-5020
Application NumberBLA103353
Marketing CategoryC73585
Route of AdministrationINTRAVENOUS
Effective DateDecember 2, 2009
Generic Namefilgrastim
INGREDIENTS (5)
FILGRASTIMActive
Quantity: 300 ug in 0.5 mL
Code: PVI5M0M1GW
Classification: ACTIB
POLYSORBATE 80Inactive
Quantity: 0.02 mg in 0.5 mL
Code: 6OZP39ZG8H
Classification: IACT
SODIUM POLYMETAPHOSPHATEInactive
Quantity: 0.0175 mg in 0.5 mL
Code: P1BM4ZH95L
Classification: IACT
SORBITOLInactive
Quantity: 25.0 mg in 0.5 mL
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT