Application 021253

Type: NDA
Sponsor: LILLY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZYPREXA	OLANZAPINE	INJECTABLE;INTRAMUSCULAR	10MG/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021253-001	ZYPREXA	OLANZAPINE	10MG/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2004-03-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N021253-001	AP

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021253-001	ZYPREXA	10MG/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N021253-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021253-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021253-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021253-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021253-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021253-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021253-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021253-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021253-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021253-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021253-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021253-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021253-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021253-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021253-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021253-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021253-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021253-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021253-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021253-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021253-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021253-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021253-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021253-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021253-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021253-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021253-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021253-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021253-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021253-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021253-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021253-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021253-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021253-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021253-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021253-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021253-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021253-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021253-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021253-001	AP	1	`3a93d1ddd44b…`

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 5 · 95 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	Coupler LLC	5af81f87-5582-aa23-e063-6294a90a1ee8	2026-09-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Hikma Pharmaceuticals USA Inc.	63bcfe98-d1fc-4cd7-9212-f59ee4dcc6d1	2026-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLANZAPINE
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	c47ee16f-5a86-49f2-8d85-5f49a6c8d91e	2026-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Cardinal Health 107, LLC	38a89689-efc2-4931-8f65-868dc0248d6a	2026-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Preferred Pharmaceuticals Inc.	d349d5b7-5658-46d6-9bba-e6f6361cebb9	2026-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Preferred Pharmaceuticals Inc.	5bded04a-d848-4ac6-b7c3-ff9b9fef3d29	2026-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Major Pharmaceuticals	709d79a1-2742-4629-af43-161be166833a	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLANZAPINE
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	9eb6b0d1-b301-4847-88f5-f8613d550ecc	2026-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLANZAPINE
Olanzapine	OLANZAPINE	PD-Rx Pharmaceuticals, Inc.	b6f0b2e2-3cbd-4564-8b3e-f811589af275	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLANZAPINE
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	3d69af75-7615-4ec2-b7ef-467b2558c5c8	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Dr. Reddy's Laboratories Ltd.	a4c525da-c2f6-b804-af49-601295922254	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLANZAPINE
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	ad350abc-a1fc-4be4-b2be-c629121552a0	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLANZAPINE
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	b513823d-927c-4111-8766-e6c37f84b221	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLANZAPINE
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	68de2a51-69b2-4d99-be79-36a95a4bc475	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Major Pharmaceuticals	0ecbf540-572e-4ca4-b694-18ca1cd1c194	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLANZAPINE
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	1705bab2-a2f8-4534-b1fc-eb309cd2696b	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Camber Pharmaceuticals, Inc.	c1387008-6dc4-4f1e-ae29-fa7a0f0be684	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLANZAPINE
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	8e5ef52d-315b-4055-9e52-403e6f896f24	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLANZAPINE
olanzapine	OLANZAPINE	Bionpharma Inc.	8f485576-a4c4-45d4-816f-2e59fce9f517	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Unit Dose Solutions, Inc.	55669a10-93f3-cfd6-e063-6294a90aa0e6	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLANZAPINE

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0002-7597	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-7597	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-7597	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-7597	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-7597	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-7597	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
64725-7597	ZYPREXA	Olanzapine	TYA Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84955	SUPPL	2026-02-05
84954	SUPPL	2026-02-05
84891	SUPPL	2026-02-03
81163	SUPPL	2025-02-07
81000	SUPPL	2025-02-05
62678	SUPPL	2020-04-24
62667	SUPPL	2020-04-24
62666	SUPPL	2020-04-24
62639	SUPPL	2020-04-22
62638	SUPPL	2020-04-22
62631	SUPPL	2020-04-22
60683	SUPPL	2019-10-25
60682	SUPPL	2019-10-25
60637	SUPPL	2019-10-23
53522	SUPPL	2018-03-29
53474	SUPPL	2018-03-28
47381	SUPPL	2017-03-02
47380	SUPPL	2017-03-02
47343	SUPPL	2017-02-27
47342	SUPPL	2017-02-27
45982	SUPPL	2016-12-01
45534	SUPPL	2016-10-14
36474	SUPPL	2015-07-24
36473	SUPPL	2015-01-09
4791	SUPPL	2014-12-23
23638	ORIG	2011-12-22
4790	SUPPL	2010-12-06
36472	SUPPL	2010-12-04
36471	SUPPL	2010-06-03
27226	SUPPL	2010-06-03
14760	SUPPL	2010-06-03
4789	SUPPL	2010-06-03
4788	SUPPL	2010-02-01
14759	SUPPL	2010-01-29
4787	SUPPL	2009-11-19
14758	SUPPL	2009-09-17
4786	SUPPL	2008-08-19
36470	SUPPL	2007-07-10
27225	SUPPL	2007-07-10
4785	SUPPL	2006-12-28
14757	SUPPL	2006-12-04
4781	SUPPL	2006-09-18
14754	SUPPL	2006-08-29
4784	SUPPL	2006-03-01
14756	SUPPL	2006-02-28
14755	SUPPL	2006-02-22
14753	SUPPL	2006-02-22
4782	SUPPL	2006-02-22
4780	SUPPL	2006-02-22
4783	SUPPL	2005-09-15
42056	ORIG	2005-07-13
27224	ORIG	2004-04-07
36469	ORIG	2004-04-05