FDA.reportPublic FDA data

Application 021729

Type
NDA
Sponsor
OTSUKA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002ABILIFYARIPIPRAZOLETABLET, ORALLY DISINTEGRATING;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003ABILIFYARIPIPRAZOLETABLET, ORALLY DISINTEGRATING;ORAL15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004ABILIFYARIPIPRAZOLETABLET, ORALLY DISINTEGRATING;ORAL20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
005ABILIFYARIPIPRAZOLETABLET, ORALLY DISINTEGRATING;ORAL30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59148-640ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-640ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-640ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-641ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-641ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-641ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61827SUPPL2020-02-06
61826SUPPL2020-02-06
61825SUPPL2020-02-06
61824SUPPL2020-02-06
61799SUPPL2020-02-06
61798SUPPL2020-02-06
59638SUPPL2019-08-08
59637SUPPL2019-08-08
59624SUPPL2019-08-08
47426SUPPL2017-03-02
47328SUPPL2017-02-24
45102SUPPL2016-08-23
45147SUPPL2016-08-18
37545SUPPL2016-01-22
6071SUPPL2016-01-20
28483SUPPL2014-12-15
16271SUPPL2014-12-15
6069SUPPL2014-07-11
37543SUPPL2014-06-10
37544SUPPL2013-08-09
6070SUPPL2013-08-05
6068SUPPL2012-02-27
16270SUPPL2012-02-24
42289SUPPL2012-01-27
42288SUPPL2012-01-27
21794SUPPL2012-01-27
23673ORIG2011-12-22
6067SUPPL2011-03-08
16269SUPPL2011-03-07
16268SUPPL2011-02-24
28481SUPPL2011-02-18
6066SUPPL2010-12-07
37542SUPPL2010-12-03
28482SUPPL2010-12-03
37541SUPPL2010-12-02
28480SUPPL2009-07-24
16267SUPPL2009-07-23
37540SUPPL2008-08-26
28479SUPPL2008-08-19
44645SUPPL2008-07-17
24214SUPPL2008-07-17
24213SUPPL2008-07-17
28478SUPPL2008-05-14
28476SUPPL2008-05-14
6064SUPPL2008-05-14
6065SUPPL2008-03-07
28477SUPPL2008-02-29
37539SUPPL2008-02-28
37538SUPPL2007-11-19
6063SUPPL2007-11-19
6062SUPPL2007-11-08
16266SUPPL2007-11-07
6061SUPPL2007-10-04
37537SUPPL2007-09-26
42287ORIG2007-08-31
37536SUPPL2006-10-23
28475SUPPL2006-10-23
28474ORIG2006-06-12
37535ORIG2006-06-08
51607SUPPL1900-01-01