FDA.reportPublic FDA data

Application 125294

Type
BLA
Sponsor
SICOR BIOTECH

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125294Granixtbo-filgrastim351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GRANIXTBO-FILGRASTIMINJECTABLE; INJECTION300MCG/0.5MLNoNo
002GRANIXTBO-FILGRASTIMINJECTABLE; INJECTION480MCG/0.8MLNoNo

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 ยท 24 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63459-910GRANIXtbo-filgrastimCephalon, Inc.BLACurrent
63459-910GRANIXtbo-filgrastimCephalon, Inc.BLACurrent
63459-910GRANIXtbo-filgrastimCephalon, LLCBLACurrent
63459-910GRANIXtbo-filgrastimCephalon, Inc.BLACurrent
63459-910GRANIXtbo-filgrastimCephalon, LLCBLACurrent
63459-910GRANIXtbo-filgrastimCephalon, Inc.BLACurrent
63459-912GRANIXtbo-filgrastimCephalon, Inc.BLACurrent
63459-912GRANIXtbo-filgrastimCephalon, Inc.BLACurrent
63459-912GRANIXtbo-filgrastimCephalon, LLCBLACurrent
63459-912GRANIXtbo-filgrastimCephalon, Inc.BLACurrent
63459-912GRANIXtbo-filgrastimCephalon, LLCBLACurrent
63459-912GRANIXtbo-filgrastimCephalon, Inc.BLACurrent
63459-918GRANIXtbo-filgrastimCephalon, Inc.BLACurrent
63459-918GRANIXtbo-filgrastimCephalon, Inc.BLACurrent
63459-918GRANIXtbo-filgrastimCephalon, LLCBLACurrent
63459-918GRANIXtbo-filgrastimCephalon, Inc.BLACurrent
63459-918GRANIXtbo-filgrastimCephalon, LLCBLACurrent
63459-918GRANIXtbo-filgrastimCephalon, Inc.BLACurrent
63459-920GRANIXtbo-filgrastimCephalon, Inc.BLACurrent
63459-920GRANIXtbo-filgrastimCephalon, Inc.BLACurrent
63459-920GRANIXtbo-filgrastimCephalon, LLCBLACurrent
63459-920GRANIXtbo-filgrastimCephalon, Inc.BLACurrent
63459-920GRANIXtbo-filgrastimCephalon, LLCBLACurrent
63459-920GRANIXtbo-filgrastimCephalon, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76655SUPPL 2023-11-24
76647SUPPL 2023-11-22
60509SUPPL2019-10-10
58178SUPPL2019-04-02
58156SUPPL2019-03-29
55093SUPPL2018-08-03
55074SUPPL2018-08-02
48799SUPPL2017-06-22
48797SUPPL2017-06-22
47099SUPPL2017-02-03
47096SUPPL2017-02-03
18859SUPPL2014-12-22
39914SUPPL2013-07-23
31917SUPPL2013-07-22
44799ORIG2012-09-26
22801ORIG2012-09-26
9694ORIG2012-09-04
18858ORIG2012-08-31
64128ORIG1900-01-01
64127ORIG1900-01-01
63249SUPPL1900-01-01
63248SUPPL1900-01-01
63247SUPPL1900-01-01