FDA.reportPublic FDA data

Application 078583

Type
ANDA
Sponsor
APOTEX INC

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
0904-6509AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
0904-6509AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
0904-6509AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
0904-6509AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
0904-6510AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
0904-6510AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
0904-6510AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
0904-6510AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
0904-6511AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
0904-6511AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
0904-6511AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
0904-6511AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
0904-6512AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
0904-6512AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
0904-6512AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
0904-6512AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
0904-6513AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
0904-6513AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
0904-6513AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
0904-6513AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
0904-6514AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
0904-6514AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
0904-6514AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
0904-6514AripiprazoleAripiprazoleMajor PharmaceuticalsANDACurrent
43353-140AripiprazoleAripiprazoleAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-147AripiprazoleAripiprazoleAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-148AripiprazoleAripiprazoleAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-180AripiprazoleAripiprazoleAphena Pharma Solutions - Tennessee, LLCANDACurrent
48433-115AripiprazoleAripiprazoleSafecor Health, LLCANDACurrent
48433-115AripiprazoleAripiprazoleSafecor Health, LLCANDACurrent
48433-115AripiprazoleAripiprazoleSafecor Health, LLCANDACurrent
48433-116AripiprazoleAripiprazoleSafecor Health, LLCANDACurrent
48433-116AripiprazoleAripiprazoleSafecor Health, LLCANDACurrent
48433-116AripiprazoleAripiprazoleSafecor Health, LLCANDACurrent
48433-117AripiprazoleAripiprazoleSafecor Health, LLCANDACurrent
48433-117AripiprazoleAripiprazoleSafecor Health, LLCANDACurrent
48433-117AripiprazoleAripiprazoleSafecor Health, LLCANDACurrent
48433-118AripiprazoleAripiprazoleSafecor Health, LLCANDACurrent
48433-118AripiprazoleAripiprazoleSafecor Health, LLCANDACurrent
48433-118AripiprazoleAripiprazoleSafecor Health, LLCANDACurrent
48433-119AripiprazoleAripiprazoleSafecor Health, LLCANDACurrent
48433-119AripiprazoleAripiprazoleSafecor Health, LLCANDACurrent
48433-119AripiprazoleAripiprazoleSafecor Health, LLCANDACurrent
48433-120AripiprazoleAripiprazoleSafecor Health, LLCANDACurrent
48433-120AripiprazoleAripiprazoleSafecor Health, LLCANDACurrent
48433-120AripiprazoleAripiprazoleSafecor Health, LLCANDACurrent
60429-446AripiprazoleAripiprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-446AripiprazoleAripiprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-446AripiprazoleAripiprazoleGolden State Medical SupplyANDACurrent
60429-446AripiprazoleAripiprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-446AripiprazoleAripiprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-447AripiprazoleAripiprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-447AripiprazoleAripiprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-447AripiprazoleAripiprazoleGolden State Medical SupplyANDACurrent
60429-447AripiprazoleAripiprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-448AripiprazoleAripiprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-448AripiprazoleAripiprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-448AripiprazoleAripiprazoleGolden State Medical SupplyANDACurrent
60429-448AripiprazoleAripiprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-448AripiprazoleAripiprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-449AripiprazoleAripiprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-449AripiprazoleAripiprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-449AripiprazoleAripiprazoleGolden State Medical SupplyANDACurrent
60429-449AripiprazoleAripiprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-450AripiprazoleAripiprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-450AripiprazoleAripiprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-450AripiprazoleAripiprazoleGolden State Medical SupplyANDACurrent
60429-450AripiprazoleAripiprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-451AripiprazoleAripiprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-451AripiprazoleAripiprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-451AripiprazoleAripiprazoleGolden State Medical SupplyANDACurrent
60429-451AripiprazoleAripiprazoleGolden State Medical Supply, Inc.ANDACurrent
60505-2673AripiprazoleAripiprazoleApotex CorpANDACurrent
60505-2673AripiprazoleAripiprazoleApotex CorpANDACurrent
60505-2673AripiprazoleAripiprazoleApotex CorpANDACurrent
60505-2673AripiprazoleAripiprazoleApotex CorpANDACurrent
60505-2673AripiprazoleAripiprazoleApotex CorpANDACurrent
60505-2673AripiprazoleAripiprazoleApotex CorpANDACurrent
60505-2674AripiprazoleAripiprazoleApotex CorpANDACurrent
60505-2674AripiprazoleAripiprazoleApotex CorpANDACurrent