Application 022173

Type: NDA
Sponsor: ELI LILLY CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZYPREXA RELPREVV	OLANZAPINE PAMOATE	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	EQ 210MG BASE/VIAL	Yes	No
002	ZYPREXA RELPREVV	OLANZAPINE PAMOATE	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	EQ 300MG BASE/VIAL	Yes	No
003	ZYPREXA RELPREVV	OLANZAPINE PAMOATE	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	EQ 405MG BASE/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N022173-001	ZYPREXA RELPREVV	OLANZAPINE PAMOATE	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11
N022173-002	ZYPREXA RELPREVV	OLANZAPINE PAMOATE	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11
N022173-003	ZYPREXA RELPREVV	OLANZAPINE PAMOATE	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`301d65b070ca…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZYPREXA Relprevv	OLANZAPINE PAMOATE	H2-Pharma LLC	11544cba-64a9-49cb-8d74-da228053b252	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022173 application number: NDA022173

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0002-7635	ZYPREXA	Olanzapine pamoate	Eli Lilly and Company	NDA	Current
0002-7635	ZYPREXA	Olanzapine pamoate	Eli Lilly and Company	NDA	Current
0002-7635	ZYPREXA	Olanzapine pamoate	Eli Lilly and Company	NDA	Current
0002-7635	ZYPREXA	Olanzapine pamoate	Eli Lilly and Company	NDA	Current
0002-7635	ZYPREXA	Olanzapine pamoate	Eli Lilly and Company	NDA	Current
0002-7635	ZYPREXA	Olanzapine pamoate	Eli Lilly and Company	NDA	Current
0002-7635	ZYPREXA	Olanzapine pamoate	Eli Lilly and Company	NDA	Current
0002-7636	ZYPREXA	Olanzapine pamoate	Eli Lilly and Company	NDA	Current
0002-7636	ZYPREXA	Olanzapine pamoate	Eli Lilly and Company	NDA	Current
0002-7636	ZYPREXA	Olanzapine pamoate	Eli Lilly and Company	NDA	Current
0002-7636	ZYPREXA	Olanzapine pamoate	Eli Lilly and Company	NDA	Current
0002-7636	ZYPREXA	Olanzapine pamoate	Eli Lilly and Company	NDA	Current
0002-7636	ZYPREXA	Olanzapine pamoate	Eli Lilly and Company	NDA	Current
0002-7636	ZYPREXA	Olanzapine pamoate	Eli Lilly and Company	NDA	Current
0002-7637	ZYPREXA	Olanzapine pamoate	Eli Lilly and Company	NDA	Current
0002-7637	ZYPREXA	Olanzapine pamoate	Eli Lilly and Company	NDA	Current
0002-7637	ZYPREXA	Olanzapine pamoate	Eli Lilly and Company	NDA	Current
0002-7637	ZYPREXA	Olanzapine pamoate	Eli Lilly and Company	NDA	Current
0002-7637	ZYPREXA	Olanzapine pamoate	Eli Lilly and Company	NDA	Current
0002-7637	ZYPREXA	Olanzapine pamoate	Eli Lilly and Company	NDA	Current
0002-7637	ZYPREXA	Olanzapine pamoate	Eli Lilly and Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85956	SUPPL	2026-05-19
85955	SUPPL	2026-05-19
85928	SUPPL	2026-05-18
85927	SUPPL	2026-05-18
85866	SUPPL	2026-05-11
85865	SUPPL	2026-05-11
84956	SUPPL	2026-02-05
84892	SUPPL	2026-02-03
81167	SUPPL	2025-02-07
80955	SUPPL	2025-02-05
67273	SUPPL	2021-04-30
65901	SUPPL	2021-01-14
62679	SUPPL	2020-04-24
62661	SUPPL	2020-04-24
62660	SUPPL	2020-04-24
62653	SUPPL	2020-04-23
62641	SUPPL	2020-04-22
62640	SUPPL	2020-04-22
62632	SUPPL	2020-04-22
60659	SUPPL	2019-10-24
60658	SUPPL	2019-10-24
60638	SUPPL	2019-10-23
58384	SUPPL	2019-04-24
58315	SUPPL	2019-04-12
53521	SUPPL	2018-03-29
53478	SUPPL	2018-03-28
50579	SUPPL	2017-12-01
50534	SUPPL	2017-12-01
47383	SUPPL	2017-03-02
47382	SUPPL	2017-03-02
47349	SUPPL	2017-02-27
47348	SUPPL	2017-02-27
45535	SUPPL	2016-10-14
45602	SUPPL	2016-10-07
29354	SUPPL	2015-09-18
17044	SUPPL	2015-07-24
38334	SUPPL	2015-01-09
7002	SUPPL	2014-12-23
38335	SUPPL	2014-11-04
7003	SUPPL	2014-11-03
17045	SUPPL	2013-04-01
29353	SUPPL	2013-03-29
29352	SUPPL	2012-08-07
7001	SUPPL	2012-08-07
7000	SUPPL	2012-08-07
38333	SUPPL	2012-08-06
38332	SUPPL	2012-08-06
17043	SUPPL	2012-08-06
44175	ORIG	2011-12-22
29351	SUPPL	2010-12-06
17042	SUPPL	2010-12-04
44691	ORIG	2010-07-27
21952	ORIG	2010-07-27
6999	SUPPL	2010-07-12
38330	SUPPL	2010-06-11
38331	SUPPL	2010-06-03
29350	SUPPL	2010-06-02
6998	SUPPL	2010-06-02
17041	SUPPL	2010-05-07
6997	SUPPL	2010-05-03
24018	ORIG	2010-03-01
29349	ORIG	2009-12-29
17040	ORIG	2009-12-15