Phenytoin Cartridge

Category(s)
prescription
SPL Type(s)
Human Prescription
Oldest Current Product
2011-02-17
License(s)
ANDA
RxNORM
CARTRIDGE\PHENYTOIN
FDAOB
INJECTION\INJECTION\PHENYTOIN SODIUM\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\PHENYTOIN SODIUM
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\PHENYTOIN

product(s) by strength(s)

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091844ANDAHospira, Inc.2011-02-17PHENYTOIN SODIUMINTRAMUSCULARINJECTION, SOLUTIONANDA08974441eecbfb-b03a-4a98-ea83-8d4e347f80f6

application(s)

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

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)

#idtitlecategorytypelabelerlast updateversionproduct(s)
141eecbfb-b03a-4a98-ea83-8d4e347f80f6 (view SPL)Phenytoin SodiumInjection, USPprescriptionHuman PrescriptionHospira, Inc.2011-04-0410004091844

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