factor VIII (b-domain deleted recombinant) FC fusion protein Injection

Brand(s)
Eloctate
Category(s)
other
SPL Type(s)
Plasma Derivative
Master SPL
Biogen Idec Inc. (2014-06-07)
Oldest Current Product
2014-07-14
License(s)
BLA
RxNORM
INJECTION\FACTOR VIII (B-DOMAIN DELETED RECOMBINANT) FC FUSION PROTEIN

product(s) by strength(s)

factor viii (b-domain deleted recombinant) fc fusion protein 1 unt injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1644060801EloctateBLABiogen Idec Inc.2014-07-14125487bec39fa0-1524-4e6b-897f-db0ef093085e
2644060802EloctateBLABiogen Idec Inc.2014-07-14125487bec39fa0-1524-4e6b-897f-db0ef093085e
3644060804EloctateBLABiogen Idec Inc.2014-07-14125487bec39fa0-1524-4e6b-897f-db0ef093085e
4644060806EloctateBLABiogen Idec Inc.2014-07-14125487bec39fa0-1524-4e6b-897f-db0ef093085e

application(s)

#idtitleapprovedtradenamesfda division
1125487Antihemophilic Factor (Recombinant), Fc Fusion protein Application2014-06-06ELOCTATECBER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1bec39fa0-1524-4e6b-897f-db0ef093085e (view SPL)These highlights do not include all the information needed to use ELOCTATE safely and effectively. See full prescribing information for ELOCTATE.ELOCTATE [Antihemophilic Factor (Recombinant), Fc Fusion Protein]Lyophilized Powder for Solution For Intravenous Injection.Initial U.S. Approval: [2014]otherPlasma DerivativeBiogen Idec Inc.2014-06-072644060801, 644060802, 644060804, 644060806, 644060803, 644060805, 644060807

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