FDA.reportPublic FDA data

Application 200565

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENYTOINPHENYTOINTABLET, CHEWABLE;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7199PhenytoinPhenytoinMajor PharmaceuticalsANDACurrent
51672-4146PhenytoinPhenytoinTaro Pharmaceuticals U.S.A., IncANDACurrent
51672-4146PhenytoinPhenytoinTaro Pharmaceuticals U.S.A., IncANDACurrent
51672-4146PhenytoinPhenytoinTaro Pharmaceuticals U.S.A., IncANDACurrent
51672-4146PhenytoinPhenytoinTaro Pharmaceuticals U.S.A., IncANDACurrent
60687-156PhenytoinPhenytoinAmerican Health PackagingANDACurrent
60687-156PhenytoinPhenytoinAmerican Health PackagingANDACurrent
60687-156PhenytoinPhenytoinAmerican Health PackagingANDACurrent
60687-156PhenytoinPhenytoinAmerican Health PackagingANDACurrent
70518-0841PhenytoinPhenytoinREMEDYREPACK INC.ANDACurrent
70518-0841PhenytoinPhenytoinREMEDYREPACK INC.ANDACurrent
70518-0841PhenytoinPhenytoinREMEDYREPACK INC.ANDACurrent
70518-0841PhenytoinPhenytoinREMEDYREPACK INC.ANDACurrent
70518-0841PhenytoinPhenytoinREMEDYREPACK INC.ANDACurrent
70518-0841PhenytoinPhenytoinREMEDYREPACK INC.ANDACurrent
70518-0841PhenytoinPhenytoinREMEDYREPACK INC.ANDACurrent