FDA.reportPublic FDA data

Application 040521

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENYTOINPHENYTOINSUSPENSION;ORAL125MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0892PhenytoinPhenytoinPharmaceutical Associates, Inc.ANDACurrent
0121-0892PhenytoinPhenytoinPAI Holdings, LLCANDACurrent
0904-7079PhenytoinPhenytoinMajor PharmaceuticalsANDACurrent
0904-7079PhenytoinPhenytoinMajor PharmaceuticalsANDACurrent
17856-4069PhenytoinPhenytoinATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-4069PhenytoinPhenytoinAtlantic Biologicals CorpsANDACurrent
17856-4069PhenytoinPhenytoinAtlantic Biologicals CorpsANDACurrent
17856-4070PhenytoinPhenytoinATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-4070PhenytoinPhenytoinATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-4070PhenytoinPhenytoinATLANTIC BIOLOGICALS CORP.ANDACurrent
51672-4069PhenytoinPhenytoinTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4069PhenytoinPhenytoinTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4069PhenytoinPhenytoinTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4069PhenytoinPhenytoinTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4069PhenytoinPhenytoinTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
60687-275PhenytoinPhenytoinAmerican Health PackagingANDACurrent
60687-275PhenytoinPhenytoinAmerican Health PackagingANDACurrent
60687-275PhenytoinPhenytoinAmerican Health PackagingANDACurrent
60687-275PhenytoinPhenytoinAmerican Health PackagingANDACurrent
60687-275PhenytoinPhenytoinAmerican Health PackagingANDACurrent
70518-1967PhenytoinPhenytoinREMEDYREPACK INC.ANDACurrent
70518-1967PhenytoinPhenytoinREMEDYREPACK INC.ANDACurrent