FDA.reportPublic FDA data

Application 207105

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARIPIPRAZOLEARIPIPRAZOLETABLET;ORAL2MGNoNo
002ARIPIPRAZOLEARIPIPRAZOLETABLET;ORAL5MGNoNo
003ARIPIPRAZOLEARIPIPRAZOLETABLET;ORAL10MGNoNo
004ARIPIPRAZOLEARIPIPRAZOLETABLET;ORAL15MGNoNo
005ARIPIPRAZOLEARIPIPRAZOLETABLET;ORAL20MGNoNo
006ARIPIPRAZOLEARIPIPRAZOLETABLET;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4665AripiprazoleAripiprazoleA-S Medication SolutionsANDACurrent
50090-4665AripiprazoleAripiprazoleA-S Medication SolutionsANDACurrent
50090-4665AripiprazoleAripiprazoleA-S Medication SolutionsANDACurrent
50090-4863AripiprazoleAripiprazoleA-S Medication SolutionsANDACurrent
50090-4863AripiprazoleAripiprazoleA-S Medication SolutionsANDACurrent
50090-4936AripiprazoleAripiprazoleA-S Medication SolutionsANDACurrent
50090-4936AripiprazoleAripiprazoleA-S Medication SolutionsANDACurrent
67877-430AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-430AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-430AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-430AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-430AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-431AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-431AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-431AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-431AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-431AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-432AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-432AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-432AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-432AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-432AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-433AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-433AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-433AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-433AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-433AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-434AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-434AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-434AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-434AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-434AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-435AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-435AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-435AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-435AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-435AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
68071-2394AripiprazoleAripiprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2676AripiprazoleAripiprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2705AripiprazoleAripiprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2705AripiprazoleAripiprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2708AripiprazoleAripiprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7733AripiprazoleAripiprazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7733AripiprazoleAripiprazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7733AripiprazoleAripiprazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7808AripiprazoleAripiprazolePrefferred Pharmaceuticals Inc.ANDACurrent
68788-7808AripiprazoleAripiprazolePrefferred Pharmaceuticals Inc.ANDACurrent
68788-7808AripiprazoleAripiprazolePrefferred Pharmaceuticals Inc.ANDACurrent
68788-8089AripiprazoleAripiprazolePreferred Pharmaceuticals Inc.ANDACurrent
68788-8089AripiprazoleAripiprazolePreferred Pharmaceuticals Inc.ANDACurrent
70518-2806AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2806AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2806AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2806AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2806AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2820AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2820AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2820AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2820AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2820AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2820AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2869AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2869AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2869AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2869AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2897AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2897AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2897AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2974AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2974AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2974AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-3090AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-3090AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
71335-1687AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent
71335-1687AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent
71335-1832AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent
71335-1832AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent
71335-1903AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent
71335-1903AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent
71335-1935AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent