NDA 022173

ELI LILLY CO

FDA Drug Application

Application #022173

Documents

• Letter: 2010-05-03
• Letter: 2010-06-02
• Letter: 2010-07-12
• Letter: 2012-08-07
• Letter: 2012-08-07
• Letter: 2014-12-23
• Letter: 2014-11-03
• Label: 2009-12-15
• Label: 2010-05-07
• Label: 2010-12-04
• Label: 2012-08-06
• Label: 2015-07-24
• Label: 2013-04-01
• Review: 2010-07-27
• Other: 2010-03-01
• Letter: 2009-12-29
• Letter: 2010-06-02
• Letter: 2010-12-06
• Letter: 2012-08-07
• Letter: 2013-03-29
• Letter: 2015-09-18
• Label: 2010-06-11
• Label: 2010-06-03
• Label: 2012-08-06
• Label: 2012-08-06
• Label: 2015-01-09
• Label: 2014-11-04
• Other Important Information from FDA: 2011-12-22
• Summary Review: 2010-07-27
• Letter: 2016-10-14
• Label: 2016-10-07
• Label: 2017-02-27
• Label: 2017-02-27
• Letter: 2017-03-02
• Letter: 2017-03-02
• Label: 2017-12-01
• Letter: 2017-12-01
• Label: 2018-03-28
• Letter: 2018-03-29
• Label: 2019-04-12
• Letter: 2019-04-24
• Letter: 2019-10-23
• Label: 2019-10-24
• Medication Guide: 2019-10-24
• Letter: 2020-04-22
• Label: 2020-04-22
• Medication Guide: 2020-04-22
• Letter: 2020-04-23
• Label: 2020-04-24
• Medication Guide: 2020-04-24
• Letter: 2020-04-24
• Letter: 2021-01-14
• Letter: 2021-04-30

Application Sponsors

NDA 022173

ELI LILLY CO

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	EQ 210MG BASE/VIAL	1	ZYPREXA RELPREVV	OLANZAPINE PAMOATE
002	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	EQ 300MG BASE/VIAL	1	ZYPREXA RELPREVV	OLANZAPINE PAMOATE
003	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	EQ 405MG BASE/VIAL	1	ZYPREXA RELPREVV	OLANZAPINE PAMOATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2009-12-11	STANDARD
LABELING; Labeling	SUPPL	2	AP	2010-04-27	UNKNOWN
LABELING; Labeling	SUPPL	3	AP	2010-05-27	UNKNOWN
REMS; REMS	SUPPL	4	AP	2010-07-08	N/A
LABELING; Labeling	SUPPL	6	AP	2010-05-27	UNKNOWN
REMS; REMS	SUPPL	8	AP	2012-08-03	N/A
LABELING; Labeling	SUPPL	9	AP	2010-12-01	901 REQUIRED
REMS; REMS	SUPPL	10	AP	2012-08-03	N/A
REMS; REMS	SUPPL	14	AP	2012-08-03	N/A
LABELING; Labeling	SUPPL	15	AP	2014-12-19	STANDARD
LABELING; Labeling	SUPPL	17	AP	2015-07-23	STANDARD
REMS; REMS	SUPPL	18	AP	2013-03-27	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2015-12-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2014-02-18	STANDARD
REMS; REMS	SUPPL	23	AP	2014-10-30	N/A
LABELING; Labeling	SUPPL	24	AP	2015-09-17	STANDARD
LABELING; Labeling	SUPPL	25	AP	2016-10-06	901 REQUIRED
LABELING; Labeling	SUPPL	26	AP	2017-02-23	STANDARD
REMS; REMS	SUPPL	27	AP	2017-11-30	N/A
LABELING; Labeling	SUPPL	28	AP	2017-02-23	901 REQUIRED
LABELING; Labeling	SUPPL	29	AP	2018-03-27	STANDARD
LABELING; Labeling	SUPPL	30	AP	2019-10-22	STANDARD
REMS; REMS	SUPPL	32	AP	2019-04-11	N/A
LABELING; Labeling	SUPPL	34	AP	2020-04-23	STANDARD
REMS; REMS	SUPPL	35	AP	2020-04-22	N/A
LABELING; Labeling	SUPPL	36	AP	2020-04-21	901 REQUIRED
LABELING; Labeling	SUPPL	37	AP	2021-01-13	STANDARD
REMS; REMS	SUPPL	39	AP	2021-04-28	N/A

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	7
SUPPL	3	Null	6
SUPPL	4	Null	6
SUPPL	6	Null	7
SUPPL	8	Null	15
SUPPL	9	Null	6
SUPPL	10	Null	6
SUPPL	14	Null	6
SUPPL	15	Null	7
SUPPL	17	Null	7
SUPPL	18	Null	7
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	23	Null	7
SUPPL	24	Null	15
SUPPL	25	Null	6
SUPPL	26	Null	6
SUPPL	27	Null	6
SUPPL	28	Null	7
SUPPL	29	Null	7
SUPPL	30	Null	15
SUPPL	32	Null	15
SUPPL	34	Null	7
SUPPL	35	Null	15
SUPPL	36	Null	6
SUPPL	37	Null	15
SUPPL	39	Null	6

CDER Filings

ELI LILLY CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22173
            [companyName] => ELI LILLY CO
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/022173s034lbl.pdf#page=30"]
            [products] => [{"drugName":"ZYPREXA RELPREVV","activeIngredients":"OLANZAPINE PAMOATE","strength":"EQ 210MG BASE\/VIAL","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ZYPREXA RELPREVV","activeIngredients":"OLANZAPINE PAMOATE","strength":"EQ 300MG BASE\/VIAL","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ZYPREXA RELPREVV","activeIngredients":"OLANZAPINE PAMOATE","strength":"EQ 405MG BASE\/VIAL","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/23\/2020","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022173s034lbl.pdf\"}]","notes":""},{"actionDate":"04\/21\/2020","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022173s036lbl.pdf\"}]","notes":""},{"actionDate":"10\/22\/2019","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022173s030lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2019","submission":"SUPPL-32","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022173s032lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2018","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022173s029lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2017","submission":"SUPPL-27","supplementCategories":"REMS - 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            [supplements] => 
            [actionDate] => 2020-04-23
        )

)