Protein C Injection

Brand(s)
Ceprotin
Category(s)
other, prescription
SPL Type(s)
Human Prescription, Plasma Derivative
Master SPL
Baxter Healthcare Corporation (2014-11-28)
Oldest Current Product
2010-08-09
License(s)
BLA
RxNORM
INJECTION\PROTEIN C

product(s) by strength(s)

protein c, human 1 unt injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)dose formapplicationspl
1009444175CeprotinBLABaxter Healthcare Corporation2010-08-09PROTEIN CKIT125234a33b5ede-e5d0-4c72-ba38-419c33bc3e91
2009444179CeprotinBLABaxter Healthcare Corporation2010-08-09125234926914a9-78b2-40ea-b37d-2a55c09bf275

application(s)

#idtitleapprovedtradenamesfda division
1125234Protein C Concentrate (Human) Application2007-03-30CeprotinCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1926914a9-78b2-40ea-b37d-2a55c09bf275 (view SPL)These highlights do not include all the information needed to use CEPROTIN safely and effectively. See full prescribing information for CEPROTIN. CEPROTIN [Protein C Concentrate (Human)] Lyophilized Powder for Solution for InjectionInitial U.S. Approval: 2007otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2014-11-286009444179, 009444177
2a33b5ede-e5d0-4c72-ba38-419c33bc3e91 (view SPL)These highlights do not include all the information needed to use CEPROTIN safely and effectively. See full prescribing information for CEPROTIN. CEPROTIN [Protein C Concentrate (Human)] Lyophilized Powder for Solution for InjectionInitial U.S. Approval: 2010prescriptionHuman PrescriptionBaxter Healthcare CorporationMANUFACTURE2010-08-123009444175

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