Application 020592

Type: NDA
Sponsor: LILLY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZYPREXA	OLANZAPINE	TABLET;ORAL	2.5MG	Yes	No
002	ZYPREXA	OLANZAPINE	TABLET;ORAL	5MG	Yes	Yes
003	ZYPREXA	OLANZAPINE	TABLET;ORAL	7.5MG	Yes	No
004	ZYPREXA	OLANZAPINE	TABLET;ORAL	10MG	Yes	No
005	ZYPREXA	OLANZAPINE	TABLET;ORAL	15MG	Yes	No
006	ZYPREXA	OLANZAPINE	TABLET;ORAL	20MG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020592-001	ZYPREXA	OLANZAPINE	2.5MG	TABLET / ORAL	AB	RLD	1996-09-30
N020592-002	ZYPREXA	OLANZAPINE	5MG	TABLET / ORAL	AB	RLD, RS	1996-09-30
N020592-003	ZYPREXA	OLANZAPINE	7.5MG	TABLET / ORAL	AB	RLD	1996-09-30
N020592-004	ZYPREXA	OLANZAPINE	10MG	TABLET / ORAL	AB	RLD	1996-09-30
N020592-005	ZYPREXA	OLANZAPINE	15MG	TABLET / ORAL	AB	RLD	1997-09-09
N020592-006	ZYPREXA	OLANZAPINE	20MG	TABLET / ORAL	AB	RLD	1997-09-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N020592-001	AB
N020592-002	AB
N020592-003	AB
N020592-004	AB
N020592-005	AB
N020592-006	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 2 of 7 · 264 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
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020592-005	ZYPREXA	15MG	TABLET / ORAL	AB	RLD	1997-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020592-006	ZYPREXA	20MG	TABLET / ORAL	AB	RLD	1997-09-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020592-001	ZYPREXA	2.5MG	TABLET / ORAL	AB	RLD	1996-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020592-002	ZYPREXA	5MG	TABLET / ORAL	AB	RLD, RS	1996-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020592-003	ZYPREXA	7.5MG	TABLET / ORAL	AB	RLD	1996-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020592-004	ZYPREXA	10MG	TABLET / ORAL	AB	RLD	1996-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020592-005	ZYPREXA	15MG	TABLET / ORAL	AB	RLD	1997-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020592-006	ZYPREXA	20MG	TABLET / ORAL	AB	RLD	1997-09-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020592-001	ZYPREXA	2.5MG	TABLET / ORAL	AB	RLD	1996-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020592-002	ZYPREXA	5MG	TABLET / ORAL	AB	RLD, RS	1996-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020592-003	ZYPREXA	7.5MG	TABLET / ORAL	AB	RLD	1996-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020592-004	ZYPREXA	10MG	TABLET / ORAL	AB	RLD	1996-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020592-005	ZYPREXA	15MG	TABLET / ORAL	AB	RLD	1997-09-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020592-006	ZYPREXA	20MG	TABLET / ORAL	AB	RLD	1997-09-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020592-001	ZYPREXA	2.5MG	TABLET / ORAL	AB	RLD	1996-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020592-002	ZYPREXA	5MG	TABLET / ORAL	AB	RLD, RS	1996-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020592-003	ZYPREXA	7.5MG	TABLET / ORAL	AB	RLD	1996-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020592-004	ZYPREXA	10MG	TABLET / ORAL	AB	RLD	1996-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020592-005	ZYPREXA	15MG	TABLET / ORAL	AB	RLD	1997-09-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020592-006	ZYPREXA	20MG	TABLET / ORAL	AB	RLD	1997-09-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020592-001	ZYPREXA	2.5MG	TABLET / ORAL	AB	RLD	1996-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020592-002	ZYPREXA	5MG	TABLET / ORAL	AB	RLD, RS	1996-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020592-003	ZYPREXA	7.5MG	TABLET / ORAL	AB	RLD	1996-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020592-004	ZYPREXA	10MG	TABLET / ORAL	AB	RLD	1996-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020592-005	ZYPREXA	15MG	TABLET / ORAL	AB	RLD	1997-09-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020592-006	ZYPREXA	20MG	TABLET / ORAL	AB	RLD	1997-09-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020592-001	ZYPREXA	2.5MG	TABLET / ORAL	AB	RLD	1996-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020592-002	ZYPREXA	5MG	TABLET / ORAL	AB	RLD, RS	1996-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020592-003	ZYPREXA	7.5MG	TABLET / ORAL	AB	RLD	1996-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020592-004	ZYPREXA	10MG	TABLET / ORAL	AB	RLD	1996-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020592-005	ZYPREXA	15MG	TABLET / ORAL	AB	RLD	1997-09-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020592-006	ZYPREXA	20MG	TABLET / ORAL	AB	RLD	1997-09-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020592-001	ZYPREXA	2.5MG	TABLET / ORAL	AB	RLD	1996-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020592-002	ZYPREXA	5MG	TABLET / ORAL	AB	RLD, RS	1996-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020592-003	ZYPREXA	7.5MG	TABLET / ORAL	AB	RLD	1996-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020592-004	ZYPREXA	10MG	TABLET / ORAL	AB	RLD	1996-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020592-005	ZYPREXA	15MG	TABLET / ORAL	AB	RLD	1997-09-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020592-006	ZYPREXA	20MG	TABLET / ORAL	AB	RLD	1997-09-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020592-001	ZYPREXA	2.5MG	TABLET / ORAL	AB	RLD	1996-09-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020592-002	ZYPREXA	5MG	TABLET / ORAL	AB	RLD, RS	1996-09-30	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 264 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	N020592-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020592-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020592-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020592-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020592-005	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020592-006	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020592-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020592-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020592-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020592-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020592-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020592-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020592-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020592-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020592-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020592-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020592-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020592-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020592-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020592-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020592-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020592-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020592-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020592-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020592-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020592-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020592-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020592-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020592-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020592-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020592-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020592-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020592-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020592-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020592-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020592-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020592-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020592-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020592-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020592-004	AB	1	`fd3edfee7708…`

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 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0002-4112	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4112	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4112	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4112	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4112	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4112	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4115	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4115	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4115	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4115	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4115	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4115	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4116	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4116	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4116	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4116	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4116	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4116	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4117	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4117	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4117	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4117	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4117	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4117	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4415	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4415	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4415	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4415	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4415	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4415	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4420	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4420	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4420	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4420	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4420	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
0002-4420	Zyprexa	Olanzapine	Eli Lilly and Company	NDA	Current
21695-140	Zyprexa	Olanzapine	Rebel Distributors Corp	NDA	Current
21695-142	Zyprexa	Olanzapine	Rebel Distributors Corp	NDA	Current
21695-144	Zyprexa	Olanzapine	Rebel Distributors Corp	NDA	Current
49999-606	Zyprexa	Olanzapine	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
52959-579	Zyprexa	Olanzapine	H.J. Harkins Company, Inc.	NDA	Current
55289-213	Zyprexa	Olanzapine	PD-Rx Pharmaceuticals, Inc.	NDA	Current
68258-7090	Zyprexa	Olanzapine	Dispensing Solutions, Inc.	NDA	Current
68258-7091	Zyprexa	Olanzapine	Dispensing Solutions, Inc.	NDA	Current
68258-7092	Zyprexa	Olanzapine	Dispensing Solutions, Inc.	NDA	Current
68258-7093	Zyprexa	Olanzapine	Dispensing Solutions, Inc.	NDA	Current
70518-1465	Zyprexa	Olanzapine	REMEDYREPACK INC.	NDA	Current
70518-1465	Zyprexa	Olanzapine	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84950	SUPPL	2026-02-05
84889	SUPPL	2026-02-03
84951	SUPPL	2026-01-30
81159	SUPPL	2025-02-07
80957	SUPPL	2025-02-05
62676	SUPPL	2020-04-24
62663	SUPPL	2020-04-24
62662	SUPPL	2020-04-24
62635	SUPPL	2020-04-22
62634	SUPPL	2020-04-22
62629	SUPPL	2020-04-22
60660	SUPPL	2019-10-24
60657	SUPPL	2019-10-24
60635	SUPPL	2019-10-23
53520	SUPPL	2018-03-29
53472	SUPPL	2018-03-28
47377	SUPPL	2017-03-02
47376	SUPPL	2017-03-02
47347	SUPPL	2017-02-27
47346	SUPPL	2017-02-27
45532	SUPPL	2016-10-14
45600	SUPPL	2016-10-07
34914	SUPPL	2015-07-24
12799	SUPPL	2015-01-09
2817	SUPPL	2014-12-23
12800	SUPPL	2013-07-30
2818	SUPPL	2013-07-30
41458	SUPPL	2012-03-16
41457	SUPPL	2012-03-16
41455	SUPPL	2012-03-16
20747	SUPPL	2012-03-16
20749	SUPPL	2012-01-27
44059	ORIG	2011-12-22
41456	SUPPL	2011-06-30
20748	SUPPL	2011-06-30
34913	SUPPL	2011-06-29
12798	SUPPL	2011-06-29
25267	SUPPL	2011-06-27
25266	SUPPL	2011-06-27
44452	SUPPL	2011-01-07
25265	SUPPL	2010-12-06
12797	SUPPL	2010-12-04
34912	SUPPL	2010-06-03
34911	SUPPL	2010-06-03
25264	SUPPL	2010-06-03
2816	SUPPL	2010-06-03
25263	SUPPL	2010-02-01
34910	SUPPL	2010-01-29
25260	SUPPL	2010-01-26
2813	SUPPL	2010-01-26
12794	SUPPL	2009-12-10
12793	SUPPL	2009-12-10
25262	SUPPL	2009-11-19
34909	SUPPL	2009-09-17
20746	SUPPL	2009-09-16
20745	SUPPL	2009-09-16
34908	SUPPL	2009-03-20
2815	SUPPL	2008-08-19
20743	ORIG	2007-11-19
25261	SUPPL	2007-07-10
12796	SUPPL	2007-07-10
12795	SUPPL	2007-07-10
2814	SUPPL	2007-07-10
41454	SUPPL	2007-07-06
20744	SUPPL	2007-04-11
25259	SUPPL	2006-12-28
34907	SUPPL	2006-12-04
2809	SUPPL	2006-09-18
34905	SUPPL	2006-08-29
2812	SUPPL	2006-03-01
34906	SUPPL	2006-02-28
25258	SUPPL	2006-02-22
12792	SUPPL	2006-02-22
12791	SUPPL	2006-02-22
2810	SUPPL	2006-02-22
2811	SUPPL	2005-09-15
25257	SUPPL	2005-08-08
25256	SUPPL	2005-06-29
41453	SUPPL	2004-04-15
12790	SUPPL	2004-01-22
2808	SUPPL	2004-01-22
2807	SUPPL	2003-07-28
34904	SUPPL	2003-07-10
52115	SUPPL	1900-01-01
52114	SUPPL	1900-01-01
52113	SUPPL	1900-01-01
52111	SUPPL	1900-01-01
52110	SUPPL	1900-01-01
52109	SUPPL	1900-01-01