Application 203456

Type: ANDA
Sponsor: INVAGEN PHARMS

Application Products#

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

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

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	Approval date
A203456-001	OLANZAPINE	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16
A203456-002	OLANZAPINE	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16
A203456-003	OLANZAPINE	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16
A203456-004	OLANZAPINE	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203456-001	AB
A203456-002	AB
A203456-003	AB
A203456-004	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 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203456-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203456-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203456-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203456-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203456-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203456-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203456-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203456-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203456-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203456-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203456-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203456-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203456-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203456-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203456-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203456-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203456-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203456-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203456-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203456-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203456-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203456-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203456-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203456-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203456-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203456-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203456-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203456-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203456-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203456-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203456-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203456-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203456-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203456-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203456-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203456-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203456-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203456-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203456-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203456-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-03-16	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203456-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203456-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203456-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203456-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203456-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203456-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203456-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203456-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203456-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203456-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203456-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203456-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203456-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203456-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203456-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203456-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203456-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203456-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203456-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203456-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203456-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203456-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203456-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203456-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203456-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203456-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203456-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203456-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203456-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203456-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203456-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203456-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203456-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203456-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203456-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203456-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203456-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203456-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203456-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203456-004	AB	1	`5bbf6a4d5a75…`

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

Reported adverse events (FAERS/openFDA)#

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