FDA.report

Application 103353

Type
BLA
Sponsor
AMGEN

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001NEUPOGENFILGRASTIMVIAL300MCG/1MLNoNo
002NEUPOGENFILGRASTIMVIAL480MCG/1.6MLNoNo
003NEUPOGENFILGRASTIMSYRINGE300MGC/0.5MLNoNo
004NEUPOGENFILGRASTIMSYRINGE480MCG/0.8MLNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
55513-209NEUPOGENFilgrastimAmgen IncBLACurrent
55513-209NEUPOGENFilgrastimAmgen IncBLACurrent
55513-209NEUPOGENFilgrastimAmgen IncBLACurrent
55513-209NEUPOGENFilgrastimAmgen IncBLACurrent
55513-209NEUPOGENFilgrastimAmgen IncBLACurrent
55513-209NEUPOGENFilgrastimAmgen IncBLACurrent
55513-209NEUPOGENFilgrastimAmgen IncBLACurrent
55513-530NEUPOGENFilgrastimAmgen IncBLACurrent
55513-530NEUPOGENFilgrastimAmgen IncBLACurrent
55513-530NEUPOGENFilgrastimAmgen IncBLACurrent
55513-530NEUPOGENFilgrastimAmgen IncBLACurrent
55513-530NEUPOGENFilgrastimAmgen IncBLACurrent
55513-530NEUPOGENFilgrastimAmgen IncBLACurrent
55513-530NEUPOGENFilgrastimAmgen IncBLACurrent
55513-546NEUPOGENFilgrastimAmgen IncBLACurrent
55513-546NEUPOGENFilgrastimAmgen IncBLACurrent
55513-546NEUPOGENFilgrastimAmgen IncBLACurrent
55513-546NEUPOGENFilgrastimAmgen IncBLACurrent
55513-546NEUPOGENFilgrastimAmgen IncBLACurrent
55513-546NEUPOGENFilgrastimAmgen IncBLACurrent
55513-546NEUPOGENFilgrastimAmgen IncBLACurrent
55513-924NEUPOGENFilgrastimAmgen IncBLACurrent
55513-924NEUPOGENFilgrastimAmgen IncBLACurrent
55513-924NEUPOGENFilgrastimAmgen IncBLACurrent
55513-924NEUPOGENFilgrastimAmgen IncBLACurrent
55513-924NEUPOGENFilgrastimAmgen IncBLACurrent
55513-924NEUPOGENFilgrastimAmgen IncBLACurrent
55513-924NEUPOGENFilgrastimAmgen IncBLACurrent

Documents

DocumentSubmission typeDate
82027SUPPL 2025-04-28
82001SUPPL 2025-04-25
74023SUPPL 2023-04-19
74020SUPPL 2023-04-19
66121SUPPL2021-02-08
66114SUPPL2021-02-05
65836SUPPL2021-01-06
65824SUPPL2021-01-06
54686SUPPL2018-06-26
54642SUPPL2018-06-21
48095SUPPL2017-04-25
39649SUPPL2016-07-22
31584SUPPL2016-06-30
18577SUPPL2015-08-04
31583SUPPL2015-07-31
31582SUPPL2015-04-03
18576SUPPL2015-02-06
9386SUPPL2015-02-06
18575SUPPL2013-09-17
9385SUPPL2013-09-17
39648SUPPL2012-05-29
9384SUPPL2012-05-29
22734ORIG2011-12-02
18574SUPPL2010-03-11
31581SUPPL2010-03-08
31580SUPPL2006-11-09
18573SUPPL2006-11-09
31579SUPPL2005-01-26
18572SUPPL2005-01-26
39647SUPPL2004-03-25
39646SUPPL2004-03-25
9383SUPPL2004-03-25
9382SUPPL2004-03-25