FDA.reportPublic FDA data

Application 022173

Type
NDA
Sponsor
ELI LILLY CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZYPREXA RELPREVVOLANZAPINE PAMOATESUSPENSION, EXTENDED RELEASE;INTRAMUSCULAREQ 210MG BASE/VIALYesNo
002ZYPREXA RELPREVVOLANZAPINE PAMOATESUSPENSION, EXTENDED RELEASE;INTRAMUSCULAREQ 300MG BASE/VIALYesNo
003ZYPREXA RELPREVVOLANZAPINE PAMOATESUSPENSION, EXTENDED RELEASE;INTRAMUSCULAREQ 405MG BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-7635ZYPREXAOlanzapine pamoateEli Lilly and CompanyNDACurrent
0002-7635ZYPREXAOlanzapine pamoateEli Lilly and CompanyNDACurrent
0002-7635ZYPREXAOlanzapine pamoateEli Lilly and CompanyNDACurrent
0002-7635ZYPREXAOlanzapine pamoateEli Lilly and CompanyNDACurrent
0002-7635ZYPREXAOlanzapine pamoateEli Lilly and CompanyNDACurrent
0002-7635ZYPREXAOlanzapine pamoateEli Lilly and CompanyNDACurrent
0002-7635ZYPREXAOlanzapine pamoateEli Lilly and CompanyNDACurrent
0002-7636ZYPREXAOlanzapine pamoateEli Lilly and CompanyNDACurrent
0002-7636ZYPREXAOlanzapine pamoateEli Lilly and CompanyNDACurrent
0002-7636ZYPREXAOlanzapine pamoateEli Lilly and CompanyNDACurrent
0002-7636ZYPREXAOlanzapine pamoateEli Lilly and CompanyNDACurrent
0002-7636ZYPREXAOlanzapine pamoateEli Lilly and CompanyNDACurrent
0002-7636ZYPREXAOlanzapine pamoateEli Lilly and CompanyNDACurrent
0002-7636ZYPREXAOlanzapine pamoateEli Lilly and CompanyNDACurrent
0002-7637ZYPREXAOlanzapine pamoateEli Lilly and CompanyNDACurrent
0002-7637ZYPREXAOlanzapine pamoateEli Lilly and CompanyNDACurrent
0002-7637ZYPREXAOlanzapine pamoateEli Lilly and CompanyNDACurrent
0002-7637ZYPREXAOlanzapine pamoateEli Lilly and CompanyNDACurrent
0002-7637ZYPREXAOlanzapine pamoateEli Lilly and CompanyNDACurrent
0002-7637ZYPREXAOlanzapine pamoateEli Lilly and CompanyNDACurrent
0002-7637ZYPREXAOlanzapine pamoateEli Lilly and CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85956SUPPL 2026-05-19
85955SUPPL 2026-05-19
85928SUPPL 2026-05-18
85927SUPPL 2026-05-18
85866SUPPL 2026-05-11
85865SUPPL 2026-05-11
84956SUPPL 2026-02-05
84892SUPPL 2026-02-03
81167SUPPL 2025-02-07
80955SUPPL 2025-02-05
67273SUPPL2021-04-30
65901SUPPL2021-01-14
62679SUPPL2020-04-24
62661SUPPL2020-04-24
62660SUPPL2020-04-24
62653SUPPL2020-04-23
62641SUPPL2020-04-22
62640SUPPL2020-04-22
62632SUPPL2020-04-22
60659SUPPL2019-10-24
60658SUPPL2019-10-24
60638SUPPL2019-10-23
58384SUPPL2019-04-24
58315SUPPL2019-04-12
53521SUPPL2018-03-29
53478SUPPL2018-03-28
50579SUPPL2017-12-01
50534SUPPL2017-12-01
47383SUPPL2017-03-02
47382SUPPL2017-03-02
47349SUPPL2017-02-27
47348SUPPL2017-02-27
45535SUPPL2016-10-14
45602SUPPL2016-10-07
29354SUPPL2015-09-18
17044SUPPL2015-07-24
38334SUPPL2015-01-09
7002SUPPL2014-12-23
38335SUPPL2014-11-04
7003SUPPL2014-11-03
17045SUPPL2013-04-01
29353SUPPL2013-03-29
29352SUPPL2012-08-07
7001SUPPL2012-08-07
7000SUPPL2012-08-07
38333SUPPL2012-08-06
38332SUPPL2012-08-06
17043SUPPL2012-08-06
44175ORIG2011-12-22
29351SUPPL2010-12-06
17042SUPPL2010-12-04
44691ORIG2010-07-27
21952ORIG2010-07-27
6999SUPPL2010-07-12
38330SUPPL2010-06-11
38331SUPPL2010-06-03
29350SUPPL2010-06-02
6998SUPPL2010-06-02
17041SUPPL2010-05-07
6997SUPPL2010-05-03
24018ORIG2010-03-01
29349ORIG2009-12-29
17040ORIG2009-12-15