FDA.reportPublic FDA data

Application 084349

Type
ANDA
Sponsor
PARKE-DAVIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DILANTINPHENYTOIN SODIUMCAPSULE;ORAL30MG EXTENDEDNoYes
002DILANTINPHENYTOIN SODIUMCAPSULE;ORAL100MG EXTENDEDNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0071-0369DilantinExtended Phenytoin SodiumParke-Davis Div of Pfizer IncANDACurrent
0071-0369DilantinExtended Phenytoin SodiumParke-Davis Div of Pfizer IncANDACurrent
0071-0369DilantinExtended Phenytoin SodiumParke-Davis Div of Pfizer IncANDACurrent
0071-0369DilantinExtended Phenytoin SodiumParke-Davis Div of Pfizer IncANDACurrent
0071-0369DilantinPhenytoin SodiumParke-Davis Div of PfizerANDACurrent
0071-0369DilantinExtended Phenytoin SodiumParke-Davis Div of Pfizer IncANDACurrent
0071-0369DilantinExtended Phenytoin SodiumParke-Davis Div of Pfizer IncANDACurrent
0071-3740DilantinExtended Phenytoin SodiumParke-Davis Div of Pfizer IncANDACurrent
0071-3740DilantinExtended Phenytoin SodiumParke-Davis Div of Pfizer IncANDACurrent
0071-3740DilantinPhenytoin SodiumParke-Davis Div of PfizerANDACurrent
0071-3740DilantinExtended Phenytoin SodiumParke-Davis Div of Pfizer IncANDACurrent
0071-3740DilantinExtended Phenytoin SodiumParke-Davis Div of Pfizer IncANDACurrent
0071-3740DilantinExtended Phenytoin SodiumParke-Davis Div of Pfizer IncANDACurrent
0071-3740DilantinExtended Phenytoin SodiumParke-Davis Div of Pfizer IncANDACurrent
43353-131DilantinPhenytoin SodiumAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
50090-0029DilantinPhenytoin SodiumA-S Medication SolutionsANDACurrent
50090-0029DilantinPhenytoin SodiumA-S Medication SolutionsANDACurrent
68151-1019DilantinPhenytoin SodiumCarilion Materials ManagementANDACurrent
69189-3742DilantinPhenytoin SodiumAvera McKennan HospitalANDACurrent
70518-0980DilantinPhenytoin SodiumREMEDYREPACK INC.ANDACurrent
70518-0980DilantinPhenytoin SodiumREMEDYREPACK INC.ANDACurrent
70518-0980DilantinPhenytoin SodiumREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72260SUPPL2022-10-06
72259SUPPL2022-10-06
69329SUPPL2021-11-16
69328SUPPL2021-11-16
64791SUPPL2020-10-02
64786SUPPL2020-10-01
57040SUPPL2018-12-27
57039SUPPL2018-12-27
51839SUPPL2018-01-26
51837SUPPL2018-01-26
51835SUPPL2018-01-26
48070SUPPL2017-04-19
39581SUPPL2015-04-23
31428SUPPL2015-04-23
39580SUPPL2014-07-29
39579SUPPL2014-03-06
39575SUPPL2014-03-06
9241SUPPL2014-03-06
9239SUPPL2014-03-06
39578SUPPL2013-09-19
9240SUPPL2013-08-08
31427SUPPL2012-12-06
39577SUPPL2012-11-30
43190SUPPL2012-03-28
39576SUPPL2011-05-06
39574SUPPL2009-10-19