Phenytoin Oral Suspension

Brand(s)
Dilantin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Parke-Davis Div Of Pfizer Inc (2015-07-15)
Oldest Current Product
1953-01-06
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL SUSPENSION\PHENYTOIN
FDAOB
ORAL\SUSPENSION\PHENYTOIN
SPL Active
ORAL\SUSPENSION\PHENYTOIN
SPL Moiety
ORAL\SUSPENSION\PHENYTOIN

product(s) by strength(s)

phenytoin 25 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000712214DilantinNDAParke-Davis Div Of Pfizer Inc1953-01-06PHENYTOINORALSUSPENSIONNDA008762051742b5-b0f0-44a5-8d31-3288527b0638

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1516724069ANDATaro Pharmaceuticals U.S.A., Inc.2004-04-08PHENYTOINORALSUSPENSIONANDA040521093fd736-5971-47af-b4ef-08c1696cebe8
2597620531NDA AUTHORIZED GENERICGreenstone Llc2012-10-09PHENYTOINORALSUSPENSIONNDA00876237943ec1-a8d2-42df-967e-6f96f84c017b
3604320131ANDAMorton Grove Pharmaceuticals, Inc.2002-06-24PHENYTOINORALSUSPENSIONANDA040420efd93f07-818b-41ae-abd6-49ec5175311a
4649500231ANDALehigh Valley Technologies, Inc.2014-04-01PHENYTOINORALSUSPENSIONANDA040610cec68cad-7460-4d9d-863d-b6bcfe6905f8
5666890036ANDAVistapharm Inc.2010-05-10PHENYTOINORALSUSPENSIONANDA04034285cc5cd9-695f-4a71-9275-e0099c505185

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004725002ANDAActavis Pharma, Inc.2009-03-02PHENYTOINORALSUSPENSIONANDA0898920fa9bf20-d747-4480-bc89-d1f663404cf1

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1178560067ANDAAtlantic Biologicals Corps2002-06-24PHENYTOINORALSUSPENSION604320131ANDA04042025acb26b-04ef-4589-8955-71d777dc813d
2178564069ANDAAtlantic Biologicals Corps2004-04-08PHENYTOINORALSUSPENSION516724069ANDA0405214d746e08-0212-45e0-b4d0-ad5211718b97
3548682038ANDAPhysicians Total Care, Inc.2006-12-19PHENYTOINORALSUSPENSION604320131ANDA0404209ce9adc8-6fa2-4444-8386-14cd576ac63d
4680940533ANDAPrecision Dose Inc.2004-02-05PHENYTOINORALSUSPENSION604320131ANDA040420854af572-0433-45ce-a373-593429a37698

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040342PHENYTOINVISTAPHARM INC2001-01-31ANDA040342_001
2ANDA040420PHENYTOINWOCKHARDT EU OPERATIONS (SWISS) AG2002-04-19ANDA040420_001
3ANDA040521PHENYTOINTARO PHARMACEUTICAL INDUSTRIES LTD2004-03-08ANDA040521_001
4ANDA040610PHENYTOINVISTAPHARM INC2005-08-18ANDA040610_001
5ANDA089892PHENYTOINTrueACTAVIS MID ATLANTIC LLC1992-09-25ANDA089892_001
6NDA008762DILANTIN-125PARKE DAVIS DIV WARNER LAMBERT CONDA008762_001, NDA008762_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040342_001RXPHENYTOIN (125MG/5ML)ORALSUSPENSIONFalseAB2001-01-31PHENYTOIN
2ANDA040420_001RXPHENYTOIN (125MG/5ML)ORALSUSPENSIONFalseAB2002-04-19PHENYTOIN
3ANDA040521_001RXPHENYTOIN (125MG/5ML)ORALSUSPENSIONFalseAB2004-03-08PHENYTOIN
4ANDA040610_001RXPHENYTOIN (125MG/5ML)ORALSUSPENSIONFalseAB2005-08-18PHENYTOIN
5ANDA089892_001discontinuedPHENYTOIN (125MG/5ML)ORALSUSPENSIONFalse1992-09-25PHENYTOIN
6NDA008762_001RXPHENYTOIN (125MG/5ML)ORALSUSPENSIONTrueABDILANTIN-125
7NDA008762_002discontinuedPHENYTOIN (30MG/5ML)ORALSUSPENSIONFalseDILANTIN-125

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1051742b5-b0f0-44a5-8d31-3288527b0638 (view SPL)Dilantin-125prescriptionHuman PrescriptionParke-Davis Div Of Pfizer IncANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-07-1521000712214
2093fd736-5971-47af-b4ef-08c1696cebe8 (view SPL)Phenytoin Oral Suspension, USPprescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2015-05-016516724069
30fa9bf20-d747-4480-bc89-d1f663404cf1 (view SPL)PHENYTOIN ORAL SUSPENSION, USPprescriptionHuman PrescriptionActavis Pharma, Inc.MANUFACTURE2012-02-062004725002
425acb26b-04ef-4589-8955-71d777dc813d (view SPL)PHENYTOIN ORAL SUSPENSION, USP (Not for Parenteral Use)prescriptionHuman PrescriptionAtlantic Biologicals CorpsRELABEL, REPACK2009-08-012178560067
537943ec1-a8d2-42df-967e-6f96f84c017b (view SPL)Phenytoin Oral Suspension, USPprescriptionHuman PrescriptionGreenstone LlcANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-07-158597620531
64d746e08-0212-45e0-b4d0-ad5211718b97 (view SPL)Phenytoin Oral Suspension, USPprescriptionHuman PrescriptionAtlantic Biologicals CorpsRELABEL, REPACK2013-03-255178564069
7854af572-0433-45ce-a373-593429a37698 (view SPL)PHENYTOIN ORAL SUSPENSION, USP 100 mg/4 mLprescriptionHuman PrescriptionPrecision Dose Inc.2013-12-263680940533
885cc5cd9-695f-4a71-9275-e0099c505185 (view SPL)PHENYTOIN ORAL SUSPENSION, USP 125 mg/ 5 mLprescriptionHuman PrescriptionVistapharm Inc.ANALYSIS, MANUFACTURE2012-06-053666890036
99ce9adc8-6fa2-4444-8386-14cd576ac63d (view SPL)PHENYTOIN ORAL SUSPENSION, USP (Not for Parenteral Use)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2009-08-011548682038
10cec68cad-7460-4d9d-863d-b6bcfe6905f8 (view SPL)PHENYTOIN ORAL SUSPENSION, USP 125 mg/5 mLprescriptionHuman PrescriptionLehigh Valley Technologies, Inc.2014-03-241649500231
11efd93f07-818b-41ae-abd6-49ec5175311a (view SPL)PHENYTOIN ORAL SUSPENSION, USP For Oral Administration Only; (Not for Parenteral Use)prescriptionHuman PrescriptionMorton Grove Pharmaceuticals, Inc.2015-07-014604320131

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