FDA.reportPublic FDA data

Application 021086

Type
NDA
Sponsor
LILLY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZYPREXA ZYDISOLANZAPINETABLET, ORALLY DISINTEGRATING;ORAL5MGYesYes
002ZYPREXA ZYDISOLANZAPINETABLET, ORALLY DISINTEGRATING;ORAL10MGYesNo
003ZYPREXA ZYDISOLANZAPINETABLET, ORALLY DISINTEGRATING;ORAL15MGYesNo
004ZYPREXA ZYDISOLANZAPINETABLET, ORALLY DISINTEGRATING;ORAL20MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-4453ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-4453ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-4453ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-4453ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-4453ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-4453ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-4454ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-4454ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-4454ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-4454ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-4454ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-4454ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-4455ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-4455ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-4455ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-4455ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-4455ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-4455ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-4456ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-4456ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-4456ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-4456ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-4456ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-4456ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84952SUPPL 2026-02-05
84890SUPPL 2026-02-03
84953SUPPL 2026-01-30
81161SUPPL 2025-02-07
80959SUPPL 2025-02-05
62677SUPPL2020-04-24
62665SUPPL2020-04-24
62664SUPPL2020-04-24
62637SUPPL2020-04-22
62636SUPPL2020-04-22
62630SUPPL2020-04-22
60662SUPPL2019-10-24
60661SUPPL2019-10-24
60636SUPPL2019-10-23
53523SUPPL2018-03-29
53473SUPPL2018-03-28
47379SUPPL2017-03-02
47378SUPPL2017-03-02
47345SUPPL2017-02-27
47344SUPPL2017-02-27
45533SUPPL2016-10-14
45601SUPPL2016-10-07
14359SUPPL2015-07-24
36085SUPPL2015-01-09
26722SUPPL2014-12-23
14358SUPPL2013-07-30
4293SUPPL2013-07-30
44093ORIG2011-12-22
36084SUPPL2011-06-29
14357SUPPL2011-06-29
26721SUPPL2011-06-27
4292SUPPL2011-06-27
4291SUPPL2010-12-06
14356SUPPL2010-12-04
36083SUPPL2010-06-03
14355SUPPL2010-06-03
4290SUPPL2010-06-03
4289SUPPL2010-06-03
4288SUPPL2010-02-01
14354SUPPL2010-01-29
4287SUPPL2009-11-19
14353SUPPL2009-09-17
14351SUPPL2009-03-20
26720SUPPL2008-08-19
36082SUPPL2007-07-10
26719SUPPL2007-07-10
14352SUPPL2007-07-10
4286SUPPL2007-07-10
26718SUPPL2006-12-28
14350SUPPL2006-12-04
4284SUPPL2006-09-18
36081SUPPL2006-08-29
4285SUPPL2006-03-01
14349SUPPL2006-02-28
26717SUPPL2005-09-15
36080ORIG2000-04-06
21433ORIG2000-04-06
4283ORIG2000-04-06