FDA.reportPublic FDA data

Application 040765

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EXTENDED PHENYTOIN SODIUMPHENYTOIN SODIUMCAPSULE;ORAL100MG EXTENDEDNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6187Extended Phenytoin SodiumPhenytoin SodiumMajor PharmaceuticalsANDACurrent
0904-6187Extended Phenytoin SodiumPhenytoin SodiumMajor PharmaceuticalsANDACurrent
10135-603Extended Phenytoin SodiumPhenytoin SodiumMarlex Pharmaceuticals IncANDACurrent
42291-772Extended Phenytoin SodiumPhenytoin SodiumAvKAREANDACurrent
42291-772Extended Phenytoin SodiumPhenytoin SodiumAvKAREANDACurrent
43063-492Extended Phenytoin SodiumPhenytoin SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-492Extended Phenytoin SodiumPhenytoin SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-492Extended Phenytoin SodiumPhenytoin SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-492Extended Phenytoin SodiumPhenytoin SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-492Extended Phenytoin SodiumPhenytoin SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-2089Extended Phenytoin SodiumPhenytoin SodiumA-S Medication SolutionsANDACurrent
50090-2089Extended Phenytoin SodiumPhenytoin SodiumA-S Medication SolutionsANDACurrent
53808-1040Extended Phenytoin SodiumPhenytoin SodiumState of Florida DOH Central PharmacyANDACurrent
55154-7979Extended Phenytoin SodiumPhenytoin SodiumCardinal HealthANDACurrent
55154-7979Extended Phenytoin SodiumPhenytoin SodiumCardinal Health 107, LLCANDACurrent
55154-7979Extended Phenytoin SodiumPhenytoin SodiumCardinal HealthANDACurrent
61919-815PHENYTOIN SODIUMPHENYTOIN SODIUMDIRECT RXANDACurrent
61919-815PHENYTOIN SODIUMPHENYTOIN SODIUMDIRECT RXANDACurrent
65162-212Extended Phenytoin SodiumPhenytoin SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-212Extended Phenytoin SodiumPhenytoin SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-212Extended Phenytoin SodiumPhenytoin SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-212Extended Phenytoin SodiumPhenytoin SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-212Extended Phenytoin SodiumPhenytoin SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-212Extended Phenytoin SodiumPhenytoin SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-212Extended Phenytoin SodiumPhenytoin SodiumAmneal Pharmaceuticals LLCANDACurrent
68084-376Extended Phenytoin SodiumPhenytoin SodiumAmerican Health PackagingANDACurrent
68084-376Extended Phenytoin SodiumPhenytoin SodiumAmerican Health PackagingANDACurrent
68084-376Extended Phenytoin SodiumPhenytoin SodiumAmerican Health PackagingANDACurrent
68084-376Extended Phenytoin SodiumPhenytoin SodiumAmerican Health PackagingANDACurrent
70518-0231Extended Phenytoin SodiumPhenytoin SodiumREMEDYREPACK INC.ANDACurrent
71610-479Extended Phenytoin SodiumPhenytoin SodiumAphena Pharma Solutions - Tennessee, LLCANDACurrent