Phenytoin Injection

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
West-Ward Pharmaceuticals Corp. (2015-05-05)
Oldest Current Product
1975-07-16
License(s)
ANDA
RxNORM
INJECTION\PHENYTOIN
FDAOB
INJECTION\INJECTION\PHENYTOIN SODIUM\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\PHENYTOIN SODIUM
INTRAMUSCULAR\INJECTION\PHENYTOIN SODIUM
INTRAVENOUS\INJECTION, SOLUTION\PHENYTOIN SODIUM
INTRAVENOUS\INJECTION\PHENYTOIN SODIUM
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\PHENYTOIN
INTRAMUSCULAR\INJECTION\PHENYTOIN
INTRAVENOUS\INJECTION, SOLUTION\PHENYTOIN
INTRAVENOUS\INJECTION\PHENYTOIN

product(s) by strength(s)

phenytoin sodium 50 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091317ANDAHospira, Inc.1987-03-17PHENYTOIN SODIUMINTRAVENOUSINJECTION, SOLUTIONANDA0895217806b2aa-074d-43fd-bc8a-7266389b0d26
2398224050ANDAX-Gen Pharmaceuticals, Inc.2011-05-02PHENYTOIN SODIUMINTRAVENOUSINJECTION, SOLUTIONANDA040573ab923d09-747d-4527-9bdf-2c807a5775d2

2 ml phenytoin sodium 50 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006410493ANDAWest-Ward Pharmaceuticals Corp.1975-07-16PHENYTOIN SODIUMINTRAMUSCULARINJECTIONANDA084307035a8d4e-2063-4240-83cb-d7eebcabe301
2006416138ANDAWest-Ward Pharmaceuticals Corp.1975-07-16PHENYTOIN SODIUMINTRAMUSCULARINJECTIONANDA0843078ad1be7b-a1a4-4a2a-bf9b-d22b350aa6e7

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840317ANDAGeneral Injecatables & Vaccines, Inc2010-08-01PHENYTOIN SODIUMINTRAMUSCULARINJECTION, SOLUTION004091317ANDA08952101ab131c-7b06-4982-8cf0-4e60879e0c8c
2525840493ANDAGeneral Injecatables & Vaccines, Inc2010-03-01PHENYTOIN SODIUMINTRAMUSCULARINJECTION, SOLUTION006410493ANDA08430731d00e75-4fe0-4aec-9cba-c86cb78762c5
3525840882ANDAGeneral Injecatables & Vaccines, Inc2011-04-12PHENYTOIN SODIUMINTRAMUSCULARINJECTION, SOLUTION001439882ANDA0405731dc5c813-501a-43fe-ac86-ce5257f51410
4551545117ANDACardinal Health1975-07-16PHENYTOIN SODIUMINTRAMUSCULARINJECTION006410493ANDA084307354fb830-05eb-4e2c-bb41-e7d0e481b992
5551547461ANDACardinal Health2006-10-01PHENYTOIN SODIUMINTRAVENOUSINJECTION001439882ANDA0405737317e374-847a-4b8a-851d-467a0bb9c77e

5 ml phenytoin sodium 50 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006412555ANDAWest-Ward Pharmaceuticals Corp.1975-07-16PHENYTOIN SODIUMINTRAMUSCULARINJECTIONANDA084307035a8d4e-2063-4240-83cb-d7eebcabe301
2006416139ANDAWest-Ward Pharmaceuticals Corp.1975-07-16PHENYTOIN SODIUMINTRAMUSCULARINJECTIONANDA0843078ad1be7b-a1a4-4a2a-bf9b-d22b350aa6e7

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840555ANDAGeneral Injecatables & Vaccines, Inc2011-08-30PHENYTOIN SODIUMINTRAMUSCULARINJECTION, SOLUTION006412555ANDA084307e3d499f7-03d8-4b66-b05d-f46cb9310905
2525840881ANDAGeneral Injecatables & Vaccines, Inc2010-08-01PHENYTOIN SODIUMINTRAMUSCULARINJECTION, SOLUTION001439881ANDA0405734fecb867-7213-49ce-9d8f-433f157635d1
3551543226ANDACardinal Health2011-05-02PHENYTOIN SODIUMINTRAMUSCULARINJECTION, SOLUTION398224050ANDA0405739a214f21-8b9f-4105-8150-44bc07980698
4551547464ANDACardinal Health2006-10-01PHENYTOIN SODIUMINTRAVENOUSINJECTION001439881ANDA0405737317e374-847a-4b8a-851d-467a0bb9c77e

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040573PHENYTOIN SODIUMX-GEN PHARMACEUTICALS INC2006-09-13ANDA040573_001Phenytoin Cartridge
2ANDA040781PHENYTOIN SODIUMLUITPOLD PHARMACEUTICALS INC2007-12-04ANDA040781_001Phenytoin Cartridge
3ANDA084307PHENYTOIN SODIUMEUROHEALTH INTERNATIONAL SARLANDA084307_001Phenytoin Cartridge
4ANDA085434PHENYTOIN SODIUMTrueWATSON LABORATORIES INCANDA085434_001Phenytoin Cartridge
5ANDA088519PHENYTOIN SODIUMTrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1984-12-19ANDA088519_001Phenytoin Cartridge
6ANDA088520PHENYTOIN SODIUMTrueSOLOPAK MEDICAL PRODUCTS INC1984-12-17ANDA088520_001Phenytoin Cartridge
7ANDA088521PHENYTOIN SODIUMTrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1984-12-18ANDA088521_001Phenytoin Cartridge
8ANDA089003PHENYTOIN SODIUMTrueFRESENIUS KABI USA LLC1985-05-31ANDA089003_001Phenytoin Cartridge
9ANDA089501PHENYTOIN SODIUMTrueMARSAM PHARMACEUTICALS LLC1987-10-13ANDA089501_001Phenytoin Cartridge
10ANDA089521PHENYTOIN SODIUMHOSPIRA INC1987-03-17ANDA089521_001Phenytoin Cartridge
11ANDA089744PHENYTOIN SODIUMTrueHOSPIRA INC1987-12-18ANDA089744_001Phenytoin Cartridge
12ANDA089779PHENYTOIN SODIUMTrueMARSAM PHARMACEUTICALS LLC1992-11-27ANDA089779_001Phenytoin Cartridge
13ANDA089900PHENYTOIN SODIUMTrueWARNER CHILCOTT DIV WARNER LAMBERT CO1990-03-30ANDA089900_001Phenytoin Cartridge
14NDA010151DILANTINTruePARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CONDA010151_001Phenytoin Cartridge

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA040573_001RXPHENYTOIN SODIUM (50MG/ML)INJECTIONFalseAP2006-09-13PHENYTOIN SODIUM
2ANDA040781_001RXPHENYTOIN SODIUM (50MG/ML)INJECTIONFalseAP2007-12-04PHENYTOIN SODIUM
3ANDA084307_001RXPHENYTOIN SODIUM (50MG/ML)INJECTIONTrueAPPHENYTOIN SODIUM
4ANDA085434_001discontinuedPHENYTOIN SODIUM (50MG/ML)INJECTIONFalsePHENYTOIN SODIUM
5ANDA088519_001discontinuedPHENYTOIN SODIUM (50MG/ML)INJECTIONFalse1984-12-19PHENYTOIN SODIUM
6ANDA088520_001discontinuedPHENYTOIN SODIUM (50MG/ML)INJECTIONFalse1984-12-17PHENYTOIN SODIUM
7ANDA088521_001discontinuedPHENYTOIN SODIUM (50MG/ML)INJECTIONFalse1984-12-18PHENYTOIN SODIUM
8ANDA089003_001discontinuedPHENYTOIN SODIUM (50MG/ML)INJECTIONFalse1985-05-31PHENYTOIN SODIUM
9ANDA089501_001discontinuedPHENYTOIN SODIUM (50MG/ML)INJECTIONFalse1987-10-13PHENYTOIN SODIUM
10ANDA089521_001RXPHENYTOIN SODIUM (50MG/ML)INJECTIONFalseAP1987-03-17PHENYTOIN SODIUM
11ANDA089744_001discontinuedPHENYTOIN SODIUM (50MG/ML)INJECTIONFalse1987-12-18PHENYTOIN SODIUM
12ANDA089779_001discontinuedPHENYTOIN SODIUM (50MG/ML)INJECTIONFalse1992-11-27PHENYTOIN SODIUM
13ANDA089900_001discontinuedPHENYTOIN SODIUM (50MG/ML)INJECTIONFalse1990-03-30PHENYTOIN SODIUM
14NDA010151_001discontinuedPHENYTOIN SODIUM (50MG/ML)INJECTIONFalseDILANTIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
101ab131c-7b06-4982-8cf0-4e60879e0c8c (view SPL)Phenytoin Sodium Injection, USP 50 mg/mL 2 mL Single Dose AmpuleprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-08-251525840317
2035a8d4e-2063-4240-83cb-d7eebcabe301 (view SPL)Phenytoin Sodium Injection, USPprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.2015-05-0413006410493, 006412555
31dc5c813-501a-43fe-ac86-ce5257f51410 (view SPL)Phenytoin Sodium Inj. USP 50mg/ml SDV 2mlprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2011-04-263525840882
431d00e75-4fe0-4aec-9cba-c86cb78762c5 (view SPL)Phenytoin Sodium 100 mg Injection, USP 2 mL VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-12-197525840493
5354fb830-05eb-4e2c-bb41-e7d0e481b992 (view SPL)Phenytoin Sodium Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2015-06-045551545117
64fecb867-7213-49ce-9d8f-433f157635d1 (view SPL)Phenytoin Sodium 50 mg/mL Injection, USP 5 mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2011-04-252525840881
77317e374-847a-4b8a-851d-467a0bb9c77e (view SPL)PHENYTOIN SODIUMINJECTION, USPprescriptionHuman PrescriptionCardinal HealthREPACK2012-05-231551547461, 551547464
87806b2aa-074d-43fd-bc8a-7266389b0d26 (view SPL)Phenytoin SodiumprescriptionHuman PrescriptionHospira, Inc.2014-06-0512004091317
98ad1be7b-a1a4-4a2a-bf9b-d22b350aa6e7 (view SPL)Phenytoin Sodium Injection, USPprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE2015-05-057006416138, 006416139
109a214f21-8b9f-4105-8150-44bc07980698 (view SPL)PHENYTOIN SODIUM INJECTION, USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-09-082551543226
11ab923d09-747d-4527-9bdf-2c807a5775d2 (view SPL)PHENYTOIN SODIUM INJECTION, USPprescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.2013-11-019398224050
12e3d499f7-03d8-4b66-b05d-f46cb9310905 (view SPL)Phenytoin Sodium Injection, USP 250mg/5mLprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-11-263525840555

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