FDA.reportPublic FDA data

Application 021253

Type
NDA
Sponsor
LILLY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZYPREXAOLANZAPINEINJECTABLE;INTRAMUSCULAR10MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-7597ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-7597ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-7597ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-7597ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-7597ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
0002-7597ZYPREXAOlanzapineEli Lilly and CompanyNDACurrent
64725-7597ZYPREXAOlanzapineTYA PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84955SUPPL 2026-02-05
84954SUPPL 2026-02-05
84891SUPPL 2026-02-03
81163SUPPL 2025-02-07
81000SUPPL 2025-02-05
62678SUPPL2020-04-24
62667SUPPL2020-04-24
62666SUPPL2020-04-24
62639SUPPL2020-04-22
62638SUPPL2020-04-22
62631SUPPL2020-04-22
60683SUPPL2019-10-25
60682SUPPL2019-10-25
60637SUPPL2019-10-23
53522SUPPL2018-03-29
53474SUPPL2018-03-28
47381SUPPL2017-03-02
47380SUPPL2017-03-02
47343SUPPL2017-02-27
47342SUPPL2017-02-27
45982SUPPL2016-12-01
45534SUPPL2016-10-14
36474SUPPL2015-07-24
36473SUPPL2015-01-09
4791SUPPL2014-12-23
23638ORIG2011-12-22
4790SUPPL2010-12-06
36472SUPPL2010-12-04
36471SUPPL2010-06-03
27226SUPPL2010-06-03
14760SUPPL2010-06-03
4789SUPPL2010-06-03
4788SUPPL2010-02-01
14759SUPPL2010-01-29
4787SUPPL2009-11-19
14758SUPPL2009-09-17
4786SUPPL2008-08-19
36470SUPPL2007-07-10
27225SUPPL2007-07-10
4785SUPPL2006-12-28
14757SUPPL2006-12-04
4781SUPPL2006-09-18
14754SUPPL2006-08-29
4784SUPPL2006-03-01
14756SUPPL2006-02-28
14755SUPPL2006-02-22
14753SUPPL2006-02-22
4782SUPPL2006-02-22
4780SUPPL2006-02-22
4783SUPPL2005-09-15
42056ORIG2005-07-13
27224ORIG2004-04-07
36469ORIG2004-04-05