Factor VIII Injection

Brand(s)
Advate, Helixate, Hemofil, Koate, Kogenate, Monoclate, Novoeight, Obizur, Recombinate
Category(s)
other, prescription
SPL Type(s)
Human Prescription, Plasma Derivative
Master SPL
Novo Nordisk (2015-10-29)
Oldest Current Product
1988-02-23
License(s)
BLA
RxNORM
INJECTION\FACTOR VIII
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT

product(s) by strength(s)

antihemophilic factor, human recombinant 1 unt injection

export only product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1009442841RecombinateBLA, EXPORT ONLYBaxter Healthcare Corporation1992-12-10, 2012-01-03ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANTINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION103375d74e59ba-bfeb-4c48-9596-da44328561a9, d99348b1-edad-41de-aed9-903a6f9f279f
2009442842RecombinateBLA, EXPORT ONLYBaxter Healthcare Corporation1992-12-10, 2012-01-03ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANTINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION103375d74e59ba-bfeb-4c48-9596-da44328561a9, d99348b1-edad-41de-aed9-903a6f9f279f
3009442843RecombinateBLA, EXPORT ONLYBaxter Healthcare Corporation1992-12-10, 2012-01-03ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANTINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION103375d74e59ba-bfeb-4c48-9596-da44328561a9, d99348b1-edad-41de-aed9-903a6f9f279f

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)dose formapplicationspl
1000263782KogenateBLABayer Pharmaceuticals Corporation2000-06-26, 2013-06-2610333201c6292d-b670-415b-9d8e-7df92c0adc0f, 6d2e4c97-0fb1-4ba4-9c58-3de071029e9b
2000263785KogenateBLABayer Pharmaceuticals Corporation2000-06-26, 2013-06-2610333201c6292d-b670-415b-9d8e-7df92c0adc0f, 6d2e4c97-0fb1-4ba4-9c58-3de071029e9b
3000263787KogenateBLABayer Pharmaceuticals Corporation2009-07-31, 2013-06-2610333201c6292d-b670-415b-9d8e-7df92c0adc0f, 6d2e4c97-0fb1-4ba4-9c58-3de071029e9b
4000263792KogenateBLABayer Pharmaceuticals Corporation2005-11-1710333254c5f945-df7a-4ec6-993e-9633dda6a6ab
5000263795KogenateBLABayer Pharmaceuticals Corporation2005-11-1710333254c5f945-df7a-4ec6-993e-9633dda6a6ab
6000538132HelixateBLACsl Behring Llc2000-08-181033324e4bc43f-892a-4ca4-ad43-5383c276c61e
7000538135HelixateBLACsl Behring Llc2009-07-311033324e4bc43f-892a-4ca4-ad43-5383c276c61e
8001697810NovoeightBLANovo Nordisk2015-04-011254660a19a631-f494-48ac-8cab-7d572bf7b03d
9001697815NovoeightBLANovo Nordisk2015-04-011254660a19a631-f494-48ac-8cab-7d572bf7b03d
10001697825NovoeightBLANovo Nordisk2015-04-011254660a19a631-f494-48ac-8cab-7d572bf7b03d
11009442832RecombinateBLABaxter Healthcare Corporation2010-02-08ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANTKIT1033752a569ec5-08d7-44ab-b649-384a496e173c, 8198f921-5dea-4077-938e-010269fb7abe
12009442833RecombinateBLABaxter Healthcare Corporation2010-02-08ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANTKIT1033752a569ec5-08d7-44ab-b649-384a496e173c, 8198f921-5dea-4077-938e-010269fb7abe
13009442844RecombinateBLABaxter Healthcare Corporation2010-03-10103375d99348b1-edad-41de-aed9-903a6f9f279f
14009442921AdvateBLABaxter Healthcare Corporation2011-02-04ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANTKIT12506391ca765f-fe58-4dee-a7eb-c8d3de9f115a
15009442922AdvateBLABaxter Healthcare Corporation2011-02-04ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANTKIT12506391ca765f-fe58-4dee-a7eb-c8d3de9f115a
16009442948AdvateBLABaxter Healthcare Corporation2003-07-2512506391ca765f-fe58-4dee-a7eb-c8d3de9f115a
17009442961AdvateBLABaxter Healthcare Corporation2003-07-2512506391ca765f-fe58-4dee-a7eb-c8d3de9f115a
18009442963AdvateBLABaxter Healthcare Corporation2003-07-2512506391ca765f-fe58-4dee-a7eb-c8d3de9f115a
19009442965AdvateBLABaxter Healthcare Corporation2003-07-2512506391ca765f-fe58-4dee-a7eb-c8d3de9f115a
20009443047AdvateBLABaxter Healthcare Corporation2014-06-2512506380fa03d2-cd4c-4155-9b57-1396c4fa42da
21009443053AdvateBLABaxter Healthcare Corporation2014-06-2512506380fa03d2-cd4c-4155-9b57-1396c4fa42da
22009443054AdvateBLABaxter Healthcare Corporation2014-06-2512506380fa03d2-cd4c-4155-9b57-1396c4fa42da

antihemophilic factor, human 1 unt injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1000537632MonoclateBLACsl Behring Llc1990-05-30103953d9c17023-cbff-4d95-8f44-ef842d59d938
2000537634MonoclateBLACsl Behring Llc2004-03-04103953d9c17023-cbff-4d95-8f44-ef842d59d938
3009443940HemofilBLABaxter Healthcare Corporation1988-02-23101448b8953ff7-3bba-4a0b-a486-f26fb81f05d9
4009443946HemofilBLABaxter Healthcare Corporation1988-02-23101448b8953ff7-3bba-4a0b-a486-f26fb81f05d9
5761250667KoateBLAKedrion Biopharma, Inc1999-05-201011302f77d685-e382-b2e7-2414-0d3a3448688a
6761250672KoateBLAKedrion Biopharma, Inc1999-05-201011302f77d685-e382-b2e7-2414-0d3a3448688a

antihemophilic factor, porcine b-domain truncated recombinant 1 unt injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1009445001ObizurBLABaxter Healthcare Corporation2014-10-23125512a69ccbb3-7648-4978-8c6d-7ca6b95a9b01

application(s)

#idtitleapprovedtradenamesfda division
1101130Antihemophilic Factor (Human) Application1974-01-24Koate, Koate-DVICBER
2101448Antihemophilic Factor (Human) Application1966-03-11Hemofil MCBER
3103332Antihemophilic Factor (Recombinant) Application1993-02-25Kogenate Helixate FS Kogenate FSCBER
4103375Antihemophilic Factor (Recombinant) Application1992-12-10Bioclate (Armour), RecombinateCBER
5103953Antihemophilic Factor (Human) Application1972-09-18Monoclate, Monoclate-PCBER
6125063Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method Application2003-07-25AdvateCBER
7125466Antihemophilic Factor (Recombinant) Application2013-10-15NovoeightCBER
8125512Antihemophilic Factor (Recombinant), Porcine Sequence Application2014-10-23OBIZURCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
101c6292d-b670-415b-9d8e-7df92c0adc0f (view SPL)These highlights do not include all the information needed to use KOGENATE FS safely and effectively. See full prescribing information for KOGENATE FS.KOGENATE FS (Antihemophilic Factor [Recombinant], Formulated with Sucrose)For Intravenous Use, Lyophilized Powder for Reconstitution with Vial AdapterInitial U.S. Approval: 1993otherPlasma DerivativeBayer Pharmaceuticals CorporationAPI MANUFACTURE, MANUFACTURE2015-08-117000263782, 000263785, 000263787, 000263783, 000263786
20a19a631-f494-48ac-8cab-7d572bf7b03d (view SPL)These highlights do not include all the information needed to use Novoeight safely and effectively. See full prescribing information for Novoeight.Novoeight, Antihemophilic Factor (Recombinant)For Intravenous Injection. Lyophilized Powder for Solution Initial U.S. Approval: [2013]otherPlasma DerivativeNovo NordiskAPI MANUFACTURE, MANUFACTURE2015-10-295001697810, 001697815, 001697825, 001697820, 001697830, 001697850
32a569ec5-08d7-44ab-b649-384a496e173c (view SPL)RECOMBINATE [Antihemophilic Factor (Recombinant)]prescriptionHuman PrescriptionBaxter Healthcare CorporationLABEL, MANUFACTURE2010-05-269009442832, 009442833, 009442831
42f77d685-e382-b2e7-2414-0d3a3448688a (view SPL)Antihemophilic Factor (Human) Kote-DVI Double Viral InactivationSolvent/Detergent Treated and Heated in Final Container at 80 CotherPlasma DerivativeKedrion Biopharma, IncMANUFACTURE2013-05-1511761250667, 761250672, 761250250
54e4bc43f-892a-4ca4-ad43-5383c276c61e (view SPL)These highlights do not include all the information needed to use Helixate FS safely and effectively. See full prescribing information for Helixate FS. Helixate FS[Antihemophilic Factor (Recombinant), Formulated with Sucrose]For Intravenous Use, Lyophilized Powder for Reconstitution Initial U.S. Approval: 1993otherPlasma DerivativeCsl Behring LlcMANUFACTURE2015-08-1714000538132, 000538135, 000538131, 000538133, 000538134
654c5f945-df7a-4ec6-993e-9633dda6a6ab (view SPL)These highlights do not include all the information needed to use KOGENATE FS safely and effectively. See full prescribing information for KOGENATE FS.KOGENATE FS (Antihemophilic Factor [Recombinant], Formulated with Sucrose)For Intravenous Use, Lyophilized Powder for Reconstitution with BIO-SET, a needleless self-contained reconstitution systemInitial U.S. Approval: 1993otherPlasma DerivativeBayer Pharmaceuticals CorporationAPI MANUFACTURE, MANUFACTURE2015-08-0414000263792, 000263795, 000263793, 000263796, 000263797
76d2e4c97-0fb1-4ba4-9c58-3de071029e9b (view SPL)These highlights do not include all the information needed to use KOGENATE FS safely and effectively. See full prescribing information for KOGENATE FS.KOGENATE FS (Antihemophilic Factor [Recombinant], Formulated with Sucrose)For Intravenous Use, Lyophilized Powder for ReconstitutionInitial U.S. Approval: 1993otherPlasma DerivativeBayer Pharmaceuticals CorporationAPI MANUFACTURE, MANUFACTURE2015-08-118000263782, 000263785, 000263787, 000263783, 000263786
880fa03d2-cd4c-4155-9b57-1396c4fa42da (view SPL)These highlights do not include all the information needed to use ADVATE safely and effectively. See full prescribing information for ADVATE. ADVATE [Antihemophilic Factor (Recombinant)] Lyophilized Powder for Reconstitution for Intravenous InjectionInitial U.S. Approval: 2003otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2015-05-052009443047, 009443053, 009443054, 009443045, 009443046, 009443051, 009443052
98198f921-5dea-4077-938e-010269fb7abe (view SPL)RECOMBINATE [Antihemophilic Factor (Recombinant)]prescriptionHuman PrescriptionBaxter Healthcare CorporationLABEL, MANUFACTURE2010-05-269009442832, 009442833, 009442831
1091ca765f-fe58-4dee-a7eb-c8d3de9f115a (view SPL)These highlights do not include all the information needed to use ADVATE safely and effectively. See full prescribing information for ADVATE. ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method]For Intravenous Injection, Lyophilized Powder for ReconstitutionInitial U.S. Approval: 2003otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2012-07-129009442921, 009442922, 009442948, 009442961, 009442963, 009442965, 009442923, 009442924, 009442960, 009442962, 009442964
11a69ccbb3-7648-4978-8c6d-7ca6b95a9b01 (view SPL)These highlights do not include all the information needed to use OBIZUR safely and effectively. See full prescribing information for OBIZUR.OBIZUR [Antihemophilic Factor (Recombinant), Porcine Sequence] Lyophilized Powder for Solution for Intravenous InjectionInitial U.S. Approval: 2014otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2014-10-231009445001
12b8953ff7-3bba-4a0b-a486-f26fb81f05d9 (view SPL)HEMOFIL M Antihemophilic Factor (Human), Method M, Monoclonal Purified NanofilteredotherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2012-04-209009443940, 009443946, 009443942, 009443944
13d74e59ba-bfeb-4c48-9596-da44328561a9 (view SPL)RECOMBINATE [Antihemophilic Factor (Recombinant)]prescriptionHuman PrescriptionBaxter Healthcare CorporationLABEL, MANUFACTURE2010-05-267009442841, 009442842, 009442843
14d99348b1-edad-41de-aed9-903a6f9f279f (view SPL)RECOMBINATE [Antihemophilic Factor (Recombinant)]otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2010-12-0110009442841, 009442842, 009442843, 009442844, 009442845
15d9c17023-cbff-4d95-8f44-ef842d59d938 (view SPL)Antihemophilic Factor (Human) Monoclate-P Factor VIII:C Pasteurized Monoclonal Antibody PurifiedotherPlasma DerivativeCsl Behring LlcMANUFACTURE2014-10-067000537632, 000537634, 000537631, 000537633

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