FDA.reportPublic FDA data

Application 206174

Type
ANDA
Sponsor
AJANTA PHARMA 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
27241-051AripiprazoleAripiprazoleAjanta Pharma LimitedANDACurrent
27241-051AripiprazoleAripiprazoleAjanta Pharma USA Inc.ANDACurrent
27241-051AripiprazoleAripiprazoleAjanta Pharma LimitedANDACurrent
27241-051AripiprazoleAripiprazoleAjanta Pharma LimitedANDACurrent
27241-052AripiprazoleAripiprazoleAjanta Pharma USA Inc.ANDACurrent
27241-052AripiprazoleAripiprazoleAjanta Pharma LimitedANDACurrent
27241-052AripiprazoleAripiprazoleAjanta Pharma LimitedANDACurrent
27241-052AripiprazoleAripiprazoleAjanta Pharma LimitedANDACurrent
27241-053AripiprazoleAripiprazoleAjanta Pharma USA Inc.ANDACurrent
27241-053AripiprazoleAripiprazoleAjanta Pharma LimitedANDACurrent
27241-053AripiprazoleAripiprazoleAjanta Pharma LimitedANDACurrent
27241-053AripiprazoleAripiprazoleAjanta Pharma LimitedANDACurrent
27241-054AripiprazoleAripiprazoleAjanta Pharma USA Inc.ANDACurrent
27241-054AripiprazoleAripiprazoleAjanta Pharma LimitedANDACurrent
27241-054AripiprazoleAripiprazoleAjanta Pharma LimitedANDACurrent
27241-054AripiprazoleAripiprazoleAjanta Pharma LimitedANDACurrent
27241-055AripiprazoleAripiprazoleAjanta Pharma USA Inc.ANDACurrent
27241-055AripiprazoleAripiprazoleAjanta Pharma LimitedANDACurrent
27241-055AripiprazoleAripiprazoleAjanta Pharma LimitedANDACurrent
27241-055AripiprazoleAripiprazoleAjanta Pharma LimitedANDACurrent
27241-056AripiprazoleAripiprazoleAjanta Pharma LimitedANDACurrent
27241-056AripiprazoleAripiprazoleAjanta Pharma LimitedANDACurrent
27241-056AripiprazoleAripiprazoleAjanta Pharma USA Inc.ANDACurrent
27241-056AripiprazoleAripiprazoleAjanta Pharma LimitedANDACurrent
68788-7749AripiprazoleAripiprazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7749AripiprazoleAripiprazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7749AripiprazoleAripiprazolePreferred Pharmaceuticals, Inc.ANDACurrent
70518-1859AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-1859AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2736AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2736AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2736AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2736AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2765AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2765AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2950AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2950AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
71335-1513AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent
71335-1513AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent
71335-1515AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent
71335-1515AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent
71335-1682AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent
71335-1682AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45328ORIG2016-09-15