FDA.reportPublic FDA data

Application 205064

Type
ANDA
Sponsor
HETERO LABS LTD V

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
16714-141AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-142AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-143AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-144AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-145AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-146AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
31722-819AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-819AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-819AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-819AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-820AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-820AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-820AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-820AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-827AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-827AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-827AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-827AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-828AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-828AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-828AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-828AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-829AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-829AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-829AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-829AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-830AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-830AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-830AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-830AripiprazoleAripiprazoleCamber Pharmaceuticals, Inc.ANDACurrent
50090-5839AripiprazoleAripiprazoleA-S Medication SolutionsANDACurrent
50090-5839AripiprazoleAripiprazoleA-S Medication SolutionsANDACurrent
50090-5840AripiprazoleAripiprazoleA-S Medication SolutionsANDACurrent
50268-087AripiprazoleAripiprazoleAvPAKANDACurrent
50268-087AripiprazoleAripiprazoleAvPAKANDACurrent
50268-088AripiprazoleAripiprazoleAvPAKANDACurrent
50268-088AripiprazoleAripiprazoleAvPAKANDACurrent
50268-089AripiprazoleAripiprazoleAvPAKANDACurrent
50268-089AripiprazoleAripiprazoleAvPAKANDACurrent
50268-090AripiprazoleAripiprazoleAvPAKANDACurrent
50268-090AripiprazoleAripiprazoleAvPAKANDACurrent
50268-091AripiprazoleAripiprazoleAvPAKANDACurrent
50268-091AripiprazoleAripiprazoleAvPAKANDACurrent
50268-092AripiprazoleAripiprazoleAvPAKANDACurrent
50268-092AripiprazoleAripiprazoleAvPAKANDACurrent
60687-157AripiprazoleAripiprazoleAmerican Health PackagingANDACurrent
60687-157AripiprazoleAripiprazoleAmerican Health PackagingANDACurrent
60687-157AripiprazoleAripiprazoleAmerican Health PackagingANDACurrent
60687-168AripiprazoleAripiprazoleAmerican Health PackagingANDACurrent
60687-168AripiprazoleAripiprazoleAmerican Health PackagingANDACurrent
60687-168AripiprazoleAripiprazoleAmerican Health PackagingANDACurrent
60687-179AripiprazoleAripiprazoleAmerican Health PackagingANDACurrent
60687-179AripiprazoleAripiprazoleAmerican Health PackagingANDACurrent
60687-179AripiprazoleAripiprazoleAmerican Health PackagingANDACurrent
60687-191AripiprazoleAripiprazoleAmerican Health PackagingANDACurrent
60687-191AripiprazoleAripiprazoleAmerican Health PackagingANDACurrent
60687-191AripiprazoleAripiprazoleAmerican Health PackagingANDACurrent
60687-202AripiprazoleAripiprazoleAmerican Health PackagingANDACurrent
60687-202AripiprazoleAripiprazoleAmerican Health PackagingANDACurrent
60687-202AripiprazoleAripiprazoleAmerican Health PackagingANDACurrent
60687-213AripiprazoleAripiprazoleAmerican Health PackagingANDACurrent
60687-213AripiprazoleAripiprazoleAmerican Health PackagingANDACurrent
60687-213AripiprazoleAripiprazoleAmerican Health PackagingANDACurrent
63739-069AripiprazoleAripiprazoleMcKesson Corporation dba SKY PackagingANDACurrent
63739-069AripiprazoleAripiprazoleMcKesson Corporation dba SKY PackagingANDACurrent
63739-070AripiprazoleAripiprazoleMcKesson Corporation dba SKY PackagingANDACurrent
63739-070AripiprazoleAripiprazoleMcKesson Corporation dba SKY PackagingANDACurrent
63739-074AripiprazoleAripiprazoleMcKesson Corporation dba SKY PackagingANDACurrent
63739-074AripiprazoleAripiprazoleMcKesson Corporation dba SKY PackagingANDACurrent
63739-078AripiprazoleAripiprazoleMcKesson Corporation dba SKY PackagingANDACurrent
63739-078AripiprazoleAripiprazoleMcKesson Corporation dba SKY PackagingANDACurrent
70518-0673AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-0673AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-0676AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-0676AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-0683AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-0683AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-0765AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-0765AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2163AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent