fosphenytoin Injection

Brand(s)
Cerebyx
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
App Pharmaceuticals, Llc (2015-04-15)
Oldest Current Product
2007-08-06
License(s)
NDA, ANDA
RxNORM
INJECTION\FOSPHENYTOIN
FDAOB
INJECTION\INJECTION\FOSPHENYTOIN SODIUM\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\FOSPHENYTOIN SODIUM
INTRAMUSCULAR\INJECTION\FOSPHENYTOIN SODIUM
INTRAVENOUS\INJECTION, SOLUTION\FOSPHENYTOIN SODIUM
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\FOSPHENYTOIN
INTRAMUSCULAR\INJECTION, SOLUTION\PHENYTOIN
INTRAMUSCULAR\INJECTION\PHENYTOIN
INTRAVENOUS\INJECTION, SOLUTION\PHENYTOIN

product(s) by strength(s)

fosphenytoin sodium 75 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000696001CerebyxNDAPfizer Labs2013-10-28FOSPHENYTOIN SODIUMINTRAVENOUSINJECTION, SOLUTIONNDA020450d4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004094857ANDAHospira, Inc.2007-08-06FOSPHENYTOIN SODIUMINTRAVENOUSINJECTION, SOLUTIONANDA078158ce76cbd9-1b1b-4944-28a8-39acfb01eb1d
2101390025ANDAGeneramedix Inc.2007-08-06FOSPHENYTOIN SODIUMINTRAVENOUSINJECTION, SOLUTIONANDA0782776f42f3bb-a8ee-438c-84c6-5f803753ce70
3633230403ANDAApp Pharmaceuticals, Llc2009-12-14FOSPHENYTOIN SODIUMINTRAVENOUSINJECTION, SOLUTIONANDA078052a9f7e7fd-7ca2-47ac-8856-999e110e2b9a, b60c9c82-e5c7-4e05-98c7-5bbba4af04b2

2 ml fosphenytoin sodium 75 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000695471CerebyxNDAPfizer Labs2013-10-28FOSPHENYTOIN SODIUMINTRAMUSCULARINJECTION, SOLUTIONNDA020450de5a6711-4abb-4c3d-a18b-266b094ace11

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439788ANDAWest-Ward Pharmaceutical Corp2009-12-02FOSPHENYTOIN SODIUMINTRAMUSCULARINJECTION, SOLUTIONANDA078765c92df63b-5140-4213-8d43-8327ff6230b7
2005176902ANDAAmerican Regent, Inc.2010-07-30FOSPHENYTOIN SODIUMINTRAMUSCULARINJECTION, SOLUTIONANDA09009924028dc7-6cd9-4a7b-ac21-77e47ddef17c
3006416136ANDAWest-Ward Pharmaceuticals Corp.2007-08-06FOSPHENYTOIN SODIUMINTRAMUSCULARINJECTIONANDA077989519a44e3-8a93-456c-b71c-894513810d45
4473350833ANDASun Pharma Global Fze2009-08-14FOSPHENYTOIN SODIUMINTRAMUSCULARINJECTION, SOLUTIONANDA0784173f6b53fb-8ce9-4897-ae13-52a8a451d48c
5651620998ANDAAmneal Pharmaceuticals2013-05-17FOSPHENYTOIN SODIUMINTRAMUSCULARINJECTIONANDA07847687ff8a91-5b37-401c-b75c-dc6efd348761

10 ml fosphenytoin sodium 75 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000695474CerebyxNDAPfizer Labs2013-10-28FOSPHENYTOIN SODIUMINTRAMUSCULARINJECTION, SOLUTIONNDA020450de5a6711-4abb-4c3d-a18b-266b094ace11

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439782ANDAWest-Ward Pharmaceutical Corp2009-12-02FOSPHENYTOIN SODIUMINTRAMUSCULARINJECTION, SOLUTIONANDA078765c92df63b-5140-4213-8d43-8327ff6230b7
2006416137ANDAWest-Ward Pharmaceuticals Corp.2007-08-06FOSPHENYTOIN SODIUMINTRAMUSCULARINJECTIONANDA077989519a44e3-8a93-456c-b71c-894513810d45
3473350834ANDASun Pharma Global Fze2009-08-14FOSPHENYTOIN SODIUMINTRAMUSCULARINJECTION, SOLUTIONANDA0784173f6b53fb-8ce9-4897-ae13-52a8a451d48c
4651620999ANDAAmneal Pharmaceuticals2013-05-17FOSPHENYTOIN SODIUMINTRAMUSCULARINJECTIONANDA07847687ff8a91-5b37-401c-b75c-dc6efd348761

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076886FOSPHENYTOIN SODIUMTrueTEVA PHARMACEUTICALS USA2007-08-06ANDA076886_001
2ANDA077481FOSPHENYTOIN SODIUMBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2007-08-06ANDA077481_001
3ANDA077989FOSPHENYTOIN SODIUMHIKMA MAPLE LTD2007-08-06ANDA077989_001
4ANDA078052FOSPHENYTOIN SODIUMFRESENIUS KABI USA LLC2007-08-06ANDA078052_001
5ANDA078126FOSPHENYTOIN SODIUMTrueAPOTEX INC2007-08-06ANDA078126_001
6ANDA078137FOSPHENYTOIN SODIUMWOCKHARDT LTD2007-08-06ANDA078137_001
7ANDA078158FOSPHENYTOIN SODIUMHOSPIRA INC2007-08-06ANDA078158_001
8ANDA078277FOSPHENYTOIN SODIUMLUITPOLD PHARMACEUTICALS INC2007-08-06ANDA078277_001
9ANDA078417FOSPHENYTOIN SODIUMSUN PHARMA GLOBAL INC2008-03-18ANDA078417_001
10ANDA078476FOSPHENYTOIN SODIUMAMNEAL PHARMACEUTICALS CO GMBH2008-03-18ANDA078476_001
11ANDA078736FOSPHENYTOIN SODIUMMYLAN LABORATORIES LTD2010-06-08ANDA078736_001
12ANDA078765FOSPHENYTOIN SODIUMHIKMA FARMACEUTICA (PORTUGAL) SA2009-12-02ANDA078765_001
13ANDA090099FOSPHENYTOIN SODIUMLUITPOLD PHARMACEUTICALS INC2010-05-13ANDA090099_001
14NDA020450CEREBYXPARKE DAVIS DIV WARNER LAMBERT CO1996-08-05NDA020450_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA076886_001discontinuedFOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML)INJECTIONFalse2007-08-06FOSPHENYTOIN SODIUM
2ANDA077481_001RXFOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML)INJECTIONFalseAP2007-08-06FOSPHENYTOIN SODIUM
3ANDA077989_001RXFOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML)INJECTIONFalseAP2007-08-06FOSPHENYTOIN SODIUM
4ANDA078052_001RXFOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML)INJECTIONTrueAP2007-08-06FOSPHENYTOIN SODIUM
5ANDA078126_001discontinuedFOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML)INJECTIONFalse2007-08-06FOSPHENYTOIN SODIUM
6ANDA078137_001RXFOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML)INJECTIONFalseAP2007-08-06FOSPHENYTOIN SODIUM
7ANDA078158_001RXFOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML)INJECTIONFalseAP2007-08-06FOSPHENYTOIN SODIUM
8ANDA078277_001RXFOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML)INJECTIONFalseAP2007-08-06FOSPHENYTOIN SODIUM
9ANDA078417_001RXFOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML)INJECTIONFalseAP2008-03-18FOSPHENYTOIN SODIUM
10ANDA078476_001RXFOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML)INJECTIONFalseAP2008-03-18FOSPHENYTOIN SODIUM
11ANDA078736_001RXFOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML)INJECTIONFalseAP2010-06-08FOSPHENYTOIN SODIUM
12ANDA078765_001RXFOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML)INJECTIONFalseAP2009-12-02FOSPHENYTOIN SODIUM
13ANDA090099_001RXFOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML)INJECTIONFalseAP2010-05-13FOSPHENYTOIN SODIUM
14NDA020450_001RXFOSPHENYTOIN SODIUM (EQ 50MG PHENYTOIN NA/ML)INJECTIONFalseAP1996-08-05CEREBYX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
124028dc7-6cd9-4a7b-ac21-77e47ddef17c (view SPL)FOSPHENYTOIN SODIUM INJECTION USPprescriptionHuman PrescriptionAmerican Regent, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2010-05-274005176902
23f6b53fb-8ce9-4897-ae13-52a8a451d48c (view SPL)Fosphenytoin Sodium Injection USPprescriptionHuman PrescriptionSun Pharma Global Fzeanalysis, manufacture2009-08-061473350833, 473350834
3519a44e3-8a93-456c-b71c-894513810d45 (view SPL)Fosphenytoin Sodium Injection, USPprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE2015-06-119006416136, 006416137
46f42f3bb-a8ee-438c-84c6-5f803753ce70 (view SPL)FOSPHENYTOIN SODIUM INJECTION USPprescriptionHuman PrescriptionGeneramedix Inc.ANALYSIS, MANUFACTURE2014-08-292101390025
587ff8a91-5b37-401c-b75c-dc6efd348761 (view SPL)Fosphenytoin Sodium Injection, USP Rx OnlyprescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, MANUFACTURE, PACK2015-06-2611651620998, 651620999
6a9f7e7fd-7ca2-47ac-8856-999e110e2b9a (view SPL)Fosphenytoin Sodium Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-04-031633230403
7b60c9c82-e5c7-4e05-98c7-5bbba4af04b2 (view SPL)Fosphenytoin Sodium Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-04-156633230403
8c92df63b-5140-4213-8d43-8327ff6230b7 (view SPL)Fosphenytoin Sodium Injection, USPprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpANALYSIS, LABEL, MANUFACTURE, PACK2014-09-157001439782, 001439788
9ce76cbd9-1b1b-4944-28a8-39acfb01eb1d (view SPL)Fosphenytoin SodiumInjection, USPprescriptionHuman PrescriptionHospira, Inc.2013-08-294004094857
10d4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a (view SPL)CEREBYX (Fosphenytoin Sodium Injection)prescriptionHuman PrescriptionPfizer LabsMANUFACTURE2015-06-118000696001
11de5a6711-4abb-4c3d-a18b-266b094ace11 (view SPL)CEREBYX(Fosphenytoin Sodium Injection)prescriptionHuman PrescriptionPfizer LabsANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-07-062000695471, 000695474

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