FDA.reportPublic FDA data

Application 021713

Type
NDA
Sponsor
OTSUKA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABILIFYARIPIPRAZOLESOLUTION;ORAL1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo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
59148-013ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-013ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-013ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61823SUPPL2020-02-06
61822SUPPL2020-02-06
61821SUPPL2020-02-06
61820SUPPL2020-02-06
61797SUPPL2020-02-06
61796SUPPL2020-02-06
59636SUPPL2019-08-08
59635SUPPL2019-08-08
59623SUPPL2019-08-08
47425SUPPL2017-03-02
47329SUPPL2017-02-24
45103SUPPL2016-08-23
45148SUPPL2016-08-18
16247SUPPL2016-01-22
6037SUPPL2016-01-20
37510SUPPL2014-12-15
28449SUPPL2014-12-15
28447SUPPL2014-07-11
16245SUPPL2014-06-10
16246SUPPL2013-08-09
28448SUPPL2013-08-05
6036SUPPL2012-02-27
16244SUPPL2012-02-24
42281SUPPL2012-01-27
21787SUPPL2012-01-27
21786SUPPL2012-01-27
44147ORIG2011-12-22
6035SUPPL2011-03-08
16243SUPPL2011-03-07
37507SUPPL2011-02-24
6033SUPPL2011-02-18
6034SUPPL2010-12-07
37509SUPPL2010-12-03
28446SUPPL2010-12-03
37508SUPPL2010-12-02
28445SUPPL2009-07-24
37506SUPPL2009-07-23
37505SUPPL2008-08-26
28444SUPPL2008-08-19
44644SUPPL2008-07-17
24210SUPPL2008-07-17
24209SUPPL2008-07-17
28442SUPPL2008-05-14
28441SUPPL2008-05-14
28440SUPPL2008-05-14
28443SUPPL2008-03-07
6032SUPPL2008-02-29
16242SUPPL2008-02-28
28439SUPPL2007-11-19
16241SUPPL2007-11-19
28438SUPPL2007-11-08
37504SUPPL2007-11-07
28437SUPPL2007-10-04
16240SUPPL2007-09-26
37502SUPPL2006-10-23
28435SUPPL2006-10-23
42280ORIG2006-09-27
37503SUPPL2006-09-20
28436SUPPL2006-09-20
16239SUPPL2006-02-22
6031SUPPL2006-02-22
37501SUPPL2005-06-23
6030SUPPL2005-06-23
16238SUPPL2005-03-03
6029SUPPL2005-03-03
37500ORIG2004-12-10
28434ORIG2004-12-10
51606SUPPL1900-01-01