FDA.reportPublic FDA data

Application 078139

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONDANSETRONONDANSETRONTABLET, ORALLY DISINTEGRATING;ORAL4MGNoNo
002ONDANSETRONONDANSETRONTABLET, ORALLY DISINTEGRATING;ORAL8MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-7732OndansetronOndansetronMylan Pharmaceuticals Inc.ANDACurrent
0378-7732OndansetronOndansetronMylan Pharmaceuticals Inc.ANDACurrent
0378-7732OndansetronOndansetronMylan Pharmaceuticals Inc.ANDACurrent
0378-7732OndansetronOndansetronMylan Pharmaceuticals Inc.ANDACurrent
0378-7732OndansetronOndansetronMylan Pharmaceuticals Inc.ANDACurrent
0378-7734OndansetronOndansetronMylan Pharmaceuticals Inc.ANDACurrent
0378-7734OndansetronOndansetronMylan Pharmaceuticals Inc.ANDACurrent
0378-7734OndansetronOndansetronMylan Pharmaceuticals Inc.ANDACurrent
0378-7734OndansetronOndansetronMylan Pharmaceuticals Inc.ANDACurrent
0378-7734OndansetronOndansetronMylan Pharmaceuticals Inc.ANDACurrent
11819-365OndansetronOndansetronHHS/Program Support Center/Supply Service CenterANDACurrent
11819-371OndansetronOndansetronUnited States Department of Health & Human ServicesANDACurrent
11819-371OndansetronOndansetronUnited States Department of Health & Human ServicesANDACurrent
35356-678OndansetronOndansetronLake Erie Medical DBA Quality Care Products LLCANDACurrent
70518-1198OndansetronOndansetronREMEDYREPACK INC.ANDACurrent
70518-1198OndansetronOndansetronREMEDYREPACK INC.ANDACurrent