FDA.reportPublic FDA data

Application 078340

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMATINIB MESYLATEIMATINIB MESYLATETABLET;ORALEQ 100MG BASENoNo
002IMATINIB MESYLATEIMATINIB MESYLATETABLET;ORALEQ 400MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-704imatinib mesylateimatinib mesylateNorthStar RxLLCANDACurrent
16714-704imatinib mesylateimatinib mesylateNorthStar RxLLCANDACurrent
16714-704imatinib mesylateimatinib mesylateNorthStar RxLLCANDACurrent
16714-704imatinib mesylateimatinib mesylateNorthStar RxLLCANDACurrent
16714-704imatinib mesylateimatinib mesylateNorthStar RxLLCANDACurrent
16714-704imatinib mesylateimatinib mesylateNorthStar RxLLCANDACurrent
16714-705imatinib mesylateimatinib mesylateNorthStar RxLLCANDACurrent
16714-705imatinib mesylateimatinib mesylateNorthStar RxLLCANDACurrent
16714-705imatinib mesylateimatinib mesylateNorthStar RxLLCANDACurrent
16714-705imatinib mesylateimatinib mesylateNorthStar RxLLCANDACurrent
16714-705imatinib mesylateimatinib mesylateNorthStar RxLLCANDACurrent
16714-705imatinib mesylateimatinib mesylateNorthStar RxLLCANDACurrent
47335-472imatinib mesylateimatinib mesylateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-472imatinib mesylateimatinib mesylateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-472imatinib mesylateimatinib mesylateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-472imatinib mesylateimatinib mesylateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-472imatinib mesylateimatinib mesylateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-472imatinib mesylateimatinib mesylateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-472imatinib mesylateimatinib mesylateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-475imatinib mesylateimatinib mesylateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-475imatinib mesylateimatinib mesylateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-475imatinib mesylateimatinib mesylateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-475imatinib mesylateimatinib mesylateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-475imatinib mesylateimatinib mesylateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-475imatinib mesylateimatinib mesylateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-475imatinib mesylateimatinib mesylateSun Pharmaceutical Industries, Inc.ANDACurrent
60687-192Imatinib MesylateImatinib MesylateAmerican Health PackagingANDACurrent
60687-192Imatinib MesylateImatinib MesylateAmerican Health PackagingANDACurrent
60687-192Imatinib MesylateImatinib MesylateAmerican Health PackagingANDACurrent
60687-192Imatinib MesylateImatinib MesylateAmerican Health PackagingANDACurrent
60687-203Imatinib MesylateImatinib MesylateAmerican Health PackagingANDACurrent
60687-203Imatinib MesylateImatinib MesylateAmerican Health PackagingANDACurrent
60687-203Imatinib MesylateImatinib MesylateAmerican Health PackagingANDACurrent
60687-203Imatinib MesylateImatinib MesylateAmerican Health PackagingANDACurrent
68001-490imatinib mesylateimatinib mesylateBluePoint LaboratoriesANDACurrent
68001-490imatinib mesylateimatinib mesylateBluePoint LaboratoriesANDACurrent
68001-490imatinib mesylateimatinib mesylateBluePoint LaboratoriesANDACurrent
68001-490imatinib mesylateimatinib mesylateBluePoint LaboratoriesANDACurrent
68001-491imatinib mesylateimatinib mesylateBluePoint LaboratoriesANDACurrent
68001-491imatinib mesylateimatinib mesylateBluePoint LaboratoriesANDACurrent
68001-491imatinib mesylateimatinib mesylateBluePoint LaboratoriesANDACurrent
68001-491imatinib mesylateimatinib mesylateBluePoint LaboratoriesANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31357ORIG2015-12-08