Application 021086

Type: NDA
Sponsor: LILLY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZYPREXA ZYDIS	OLANZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	5MG	Yes	Yes
002	ZYPREXA ZYDIS	OLANZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	Yes	No
003	ZYPREXA ZYDIS	OLANZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	15MG	Yes	No
004	ZYPREXA ZYDIS	OLANZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	20MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021086-001	ZYPREXA ZYDIS	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2000-04-06
N021086-002	ZYPREXA ZYDIS	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06
N021086-003	ZYPREXA ZYDIS	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06
N021086-004	ZYPREXA ZYDIS	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N021086-001	AB
N021086-002	AB
N021086-003	AB
N021086-004	AB

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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	N021086-001	ZYPREXA ZYDIS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2000-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021086-002	ZYPREXA ZYDIS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021086-003	ZYPREXA ZYDIS	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021086-004	ZYPREXA ZYDIS	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021086-001	ZYPREXA ZYDIS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2000-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021086-002	ZYPREXA ZYDIS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021086-003	ZYPREXA ZYDIS	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021086-004	ZYPREXA ZYDIS	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021086-001	ZYPREXA ZYDIS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2000-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021086-002	ZYPREXA ZYDIS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021086-003	ZYPREXA ZYDIS	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021086-004	ZYPREXA ZYDIS	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021086-001	ZYPREXA ZYDIS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2000-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021086-002	ZYPREXA ZYDIS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021086-003	ZYPREXA ZYDIS	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021086-004	ZYPREXA ZYDIS	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021086-001	ZYPREXA ZYDIS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2000-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021086-002	ZYPREXA ZYDIS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021086-003	ZYPREXA ZYDIS	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021086-004	ZYPREXA ZYDIS	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021086-001	ZYPREXA ZYDIS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2000-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021086-002	ZYPREXA ZYDIS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021086-003	ZYPREXA ZYDIS	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021086-004	ZYPREXA ZYDIS	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021086-001	ZYPREXA ZYDIS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2000-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021086-002	ZYPREXA ZYDIS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021086-003	ZYPREXA ZYDIS	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021086-004	ZYPREXA ZYDIS	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021086-001	ZYPREXA ZYDIS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2000-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021086-002	ZYPREXA ZYDIS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021086-003	ZYPREXA ZYDIS	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021086-004	ZYPREXA ZYDIS	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021086-001	ZYPREXA ZYDIS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2000-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021086-002	ZYPREXA ZYDIS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021086-003	ZYPREXA ZYDIS	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021086-004	ZYPREXA ZYDIS	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021086-001	ZYPREXA ZYDIS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2000-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021086-002	ZYPREXA ZYDIS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021086-003	ZYPREXA ZYDIS	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021086-004	ZYPREXA ZYDIS	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2000-04-06	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021086-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021086-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021086-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021086-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021086-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021086-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021086-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021086-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021086-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021086-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021086-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021086-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021086-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021086-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021086-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021086-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021086-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021086-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021086-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021086-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021086-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021086-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021086-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021086-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021086-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021086-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021086-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021086-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021086-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021086-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021086-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021086-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021086-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021086-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021086-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021086-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021086-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021086-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021086-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021086-004	AB	1	`d06236e962d9…`

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	OLANZAPINE	H2-Pharma LLC	b418946a-1ab4-4d89-a012-d94fc361a3c4	2026-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021086 application number: NDA021086

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0002-4453	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4453	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4453	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4453	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4453	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4453	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4454	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4454	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4454	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4454	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4454	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4454	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4455	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4455	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4455	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4455	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4455	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4455	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4456	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4456	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4456	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4456	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4456	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4456	ZYPREXA	Olanzapine	Eli Lilly and Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84952	SUPPL	2026-02-05
84890	SUPPL	2026-02-03
84953	SUPPL	2026-01-30
81161	SUPPL	2025-02-07
80959	SUPPL	2025-02-05
62677	SUPPL	2020-04-24
62665	SUPPL	2020-04-24
62664	SUPPL	2020-04-24
62637	SUPPL	2020-04-22
62636	SUPPL	2020-04-22
62630	SUPPL	2020-04-22
60662	SUPPL	2019-10-24
60661	SUPPL	2019-10-24
60636	SUPPL	2019-10-23
53523	SUPPL	2018-03-29
53473	SUPPL	2018-03-28
47379	SUPPL	2017-03-02
47378	SUPPL	2017-03-02
47345	SUPPL	2017-02-27
47344	SUPPL	2017-02-27
45533	SUPPL	2016-10-14
45601	SUPPL	2016-10-07
14359	SUPPL	2015-07-24
36085	SUPPL	2015-01-09
26722	SUPPL	2014-12-23
14358	SUPPL	2013-07-30
4293	SUPPL	2013-07-30
44093	ORIG	2011-12-22
36084	SUPPL	2011-06-29
14357	SUPPL	2011-06-29
26721	SUPPL	2011-06-27
4292	SUPPL	2011-06-27
4291	SUPPL	2010-12-06
14356	SUPPL	2010-12-04
36083	SUPPL	2010-06-03
14355	SUPPL	2010-06-03
4290	SUPPL	2010-06-03
4289	SUPPL	2010-06-03
4288	SUPPL	2010-02-01
14354	SUPPL	2010-01-29
4287	SUPPL	2009-11-19
14353	SUPPL	2009-09-17
14351	SUPPL	2009-03-20
26720	SUPPL	2008-08-19
36082	SUPPL	2007-07-10
26719	SUPPL	2007-07-10
14352	SUPPL	2007-07-10
4286	SUPPL	2007-07-10
26718	SUPPL	2006-12-28
14350	SUPPL	2006-12-04
4284	SUPPL	2006-09-18
36081	SUPPL	2006-08-29
4285	SUPPL	2006-03-01
14349	SUPPL	2006-02-28
26717	SUPPL	2005-09-15
36080	ORIG	2000-04-06
21433	ORIG	2000-04-06
4283	ORIG	2000-04-06