FDA.reportPublic FDA data

Application 205080

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ITRACONAZOLEITRACONAZOLECAPSULE;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50268-450ItraconazoleItraconazoleAvPAKANDACurrent
50268-450ItraconazoleItraconazoleAvPAKANDACurrent
50268-450ItraconazoleItraconazoleAvPAKANDACurrent
60687-299ItraconazoleItraconazoleAmerican Health PackagingANDACurrent
60687-299ItraconazoleItraconazoleAmerican Health PackagingANDACurrent
60687-299ItraconazoleItraconazoleAmerican Health PackagingANDACurrent
60687-299ItraconazoleItraconazoleAmerican Health PackagingANDACurrent
60687-299ItraconazoleItraconazoleAmerican Health PackagingANDACurrent
65162-630ItraconazoleItraconazoleAmneal Pharmaceuticals LLCANDACurrent
65162-630ItraconazoleItraconazoleAmneal Pharmaceuticals LLCANDACurrent
65162-630ItraconazoleItraconazoleAmneal Pharmaceuticals LLANDACurrent
65162-630ItraconazoleItraconazoleAmneal Pharmaceuticals LLCANDACurrent
65162-630ItraconazoleItraconazoleAmneal Pharmaceuticals LLCANDACurrent