factor IX complex Injection

Brand(s)
Bebulin, Profilnine
Category(s)
other, prescription
SPL Type(s)
Human Prescription, Plasma Derivative
Master SPL
Grifols Usa, Llc (2015-07-06)
Oldest Current Product
1981-07-20
License(s)
BLA
RxNORM
INJECTION\FACTOR IX COMPLEX

product(s) by strength(s)

factor ix complex 1 unt injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1641930445BebulinBLABaxter Healthcare Corporation1992-08-19103112b375a2fb-7bd4-486c-87f6-72237713d528
2685163201ProfilnineBLAGrifols Usa, Llc1981-07-2010247679821042-86a5-4a64-b621-76de0a0bbab2
3685163203ProfilnineBLAGrifols Usa, Llc1981-07-2010247679821042-86a5-4a64-b621-76de0a0bbab2

application(s)

#idtitleapprovedtradenamesfda division
1102476Factor IX Complex Application1981-07-20Profilnine, Profilnine HP, Profilnine HT, Profilnine SDCBER
2103112Factor IX Complex Application1970-08-21Bebulin, Bebulin VHCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1527b44a6-f9e2-4eae-8f68-6b4134465196 (view SPL)BEBULIN VH(Factor IX Complex),Vapor HeatedprescriptionHuman PrescriptionBaxter Healthcare CorporationLABEL, MANUFACTURE2011-03-164641930244
279821042-86a5-4a64-b621-76de0a0bbab2 (view SPL)Factor IX ComplexProfilnine otherPlasma DerivativeGrifols Usa, LlcMANUFACTURE2015-07-0615685163201, 685163203, 685163202
3b375a2fb-7bd4-486c-87f6-72237713d528 (view SPL)BEBULIN (Factor IX Complex),Nanofiltered and Vapor HeatedLyophilized Powder for Reconstitution for Intravenous AdministrationotherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2012-07-067641930445

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