FDA.reportPublic FDA data

Application 090165

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARIPIPRAZOLEARIPIPRAZOLETABLET, ORALLY DISINTEGRATING;ORAL10MGNoNo
002ARIPIPRAZOLEARIPIPRAZOLETABLET, ORALLY DISINTEGRATING;ORAL15MGNoNo
003ARIPIPRAZOLEARIPIPRAZOLETABLET, ORALLY DISINTEGRATING;ORAL20MGNoNo
004ARIPIPRAZOLEARIPIPRAZOLETABLET, ORALLY DISINTEGRATING;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-087aripiprazolearipiprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-087aripiprazolearipiprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-087aripiprazolearipiprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-088aripiprazolearipiprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-088aripiprazolearipiprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-088aripiprazolearipiprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-089aripiprazolearipiprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-089aripiprazolearipiprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-089aripiprazolearipiprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-090aripiprazolearipiprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-090aripiprazolearipiprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-090aripiprazolearipiprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1432aripiprazolearipiprazoleCadila Healthcare LimitedANDACurrent
70771-1432aripiprazolearipiprazoleCadila Healthcare LimitedANDACurrent
70771-1432aripiprazolearipiprazoleCadila Healthcare LimitedANDACurrent
70771-1433aripiprazolearipiprazoleCadila Healthcare LimitedANDACurrent
70771-1433aripiprazolearipiprazoleCadila Healthcare LimitedANDACurrent
70771-1433aripiprazolearipiprazoleCadila Healthcare LimitedANDACurrent
70771-1434aripiprazolearipiprazoleCadila Healthcare LimitedANDACurrent
70771-1434aripiprazolearipiprazoleCadila Healthcare LimitedANDACurrent
70771-1434aripiprazolearipiprazoleCadila Healthcare LimitedANDACurrent
70771-1435aripiprazolearipiprazoleCadila Healthcare LimitedANDACurrent
70771-1435aripiprazolearipiprazoleCadila Healthcare LimitedANDACurrent
70771-1435aripiprazolearipiprazoleCadila Healthcare LimitedANDACurrent
72578-106AripiprazoleAripiprazoleViona Pharmaceuticals Inc.ANDACurrent
72578-106AripiprazoleAripiprazoleViona Pharmaceuticals Inc.ANDACurrent
72578-106AripiprazoleAripiprazoleViona Pharmaceuticals Inc.ANDACurrent
72578-107AripiprazoleAripiprazoleViona Pharmaceuticals Inc.ANDACurrent
72578-107AripiprazoleAripiprazoleViona Pharmaceuticals Inc.ANDACurrent
72578-107AripiprazoleAripiprazoleViona Pharmaceuticals Inc.ANDACurrent
76483-100AripiprazoleAripiprazoleSQUARE PHARMACEUTICALS LIMITEDANDACurrent
76483-101AripiprazoleAripiprazoleSQUARE PHARMACEUTICALS LIMITEDANDACurrent
76483-102AripiprazoleAripiprazoleSQUARE PHARMACEUTICALS LIMITEDANDACurrent
76483-103AripiprazoleAripiprazoleSQUARE PHARMACEUTICALS LIMITEDANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55411ORIG2018-09-07