Filgrastim Injection

Brand(s)
Neupogen
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Amgen Inc (2015-07-30)
Oldest Current Product
1994-06-08
License(s)
BLA
RxNORM
INJECTION\FILGRASTIM
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\FILGRASTIM, LICENSE HOLDER UNSPECIFIED
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\FILGRASTIM, LICENSE HOLDER UNSPECIFIED

product(s) by strength(s)

1 ml filgrastim 0.3 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1555130530NeupogenBLAAmgen Inc1997-05-19FILGRASTIM, LICENSE HOLDER UNSPECIFIEDINTRAVENOUSINJECTION, SOLUTION10335397cc73cc-b5b7-458a-a933-77b00523e193

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548682522NeupogenBLAPhysicians Total Care, Inc.1994-06-08FILGRASTIM, LICENSE HOLDER UNSPECIFIEDINTRAVENOUSINJECTION, SOLUTION5551305301033533bc802bd-76b4-4f45-8571-a436ec26228e

1.6 ml filgrastim 0.3 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1555130546NeupogenBLAAmgen Inc1997-04-07FILGRASTIM, LICENSE HOLDER UNSPECIFIEDINTRAVENOUSINJECTION, SOLUTION10335397cc73cc-b5b7-458a-a933-77b00523e193

application(s)

#idtitleapprovedtradenamesfda division
1103353filgrastim Application1991-02-20NeupogenCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
13bc802bd-76b4-4f45-8571-a436ec26228e (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2009-12-021548682522, 548683050, 548685020Filgrastim Prefilled Syringe
297cc73cc-b5b7-458a-a933-77b00523e193 (view SPL)These highlights do not include all the information needed to use NEUPOGEN safely and effectively. See full prescribing information for NEUPOGEN. NEUPOGEN (filgrastim) injection, for subcutaneous or intravenous use Initial U.S. Approval: 1991prescriptionHuman PrescriptionAmgen IncANALYSIS, MANUFACTURE2015-07-30144555130530, 555130546, 555130209, 555130924Filgrastim Prefilled Syringe

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII