FDA.reportPublic FDA data

Application 208591

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-743ItraconazoleItraconazoleNorthStar RxLLCANDACurrent
16714-743ItraconazoleItraconazoleNorthStar RxLLCANDACurrent
16714-743ItraconazoleItraconazoleNorthStar RxLLCANDACurrent
63629-8168ItraconazoleItraconazoleBryant Ranch PrepackANDACurrent
63629-8168ItraconazoleItraconazoleBryant Ranch PrepackANDACurrent
67877-454ItraconazoleItraconazoleAscend Laboratories, LLCANDACurrent
67877-454ItraconazoleItraconazoleAscend Laboratories, LLCANDACurrent
67877-454ItraconazoleItraconazoleAscend Laboratories, LLCANDACurrent
67877-454ItraconazoleItraconazoleAscend Laboratories, LLCANDACurrent
70518-2872ItraconazoleItraconazoleREMEDYREPACK INC.ANDACurrent
70518-2872ItraconazoleItraconazoleREMEDYREPACK INC.ANDACurrent