Application 204866

Type: ANDA
Sponsor: HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OLANZAPINE	OLANZAPINE	TABLET;ORAL	2.5MG	No	No
002	OLANZAPINE	OLANZAPINE	TABLET;ORAL	5MG	No	No
003	OLANZAPINE	OLANZAPINE	TABLET;ORAL	7.5MG	No	No
004	OLANZAPINE	OLANZAPINE	TABLET;ORAL	10MG	No	No
005	OLANZAPINE	OLANZAPINE	TABLET;ORAL	15MG	No	No
006	OLANZAPINE	OLANZAPINE	TABLET;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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A204866-001	OLANZAPINE	OLANZAPINE	2.5MG	TABLET / ORAL	2017-06-16
A204866-002	OLANZAPINE	OLANZAPINE	5MG	TABLET / ORAL	2017-06-16
A204866-003	OLANZAPINE	OLANZAPINE	7.5MG	TABLET / ORAL	2017-06-16
A204866-004	OLANZAPINE	OLANZAPINE	10MG	TABLET / ORAL	2017-06-16
A204866-005	OLANZAPINE	OLANZAPINE	15MG	TABLET / ORAL	2017-06-16
A204866-006	OLANZAPINE	OLANZAPINE	20MG	TABLET / ORAL	2017-06-16

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 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A204866-001	OLANZAPINE	2.5MG	TABLET / ORAL	2017-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204866-002	OLANZAPINE	5MG	TABLET / ORAL	2017-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204866-003	OLANZAPINE	7.5MG	TABLET / ORAL	2017-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204866-004	OLANZAPINE	10MG	TABLET / ORAL	2017-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204866-005	OLANZAPINE	15MG	TABLET / ORAL	2017-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204866-006	OLANZAPINE	20MG	TABLET / ORAL	2017-06-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204866-001	OLANZAPINE	2.5MG	TABLET / ORAL	2017-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204866-002	OLANZAPINE	5MG	TABLET / ORAL	2017-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204866-003	OLANZAPINE	7.5MG	TABLET / ORAL	2017-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204866-004	OLANZAPINE	10MG	TABLET / ORAL	2017-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204866-005	OLANZAPINE	15MG	TABLET / ORAL	2017-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204866-006	OLANZAPINE	20MG	TABLET / ORAL	2017-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204866-001	OLANZAPINE	2.5MG	TABLET / ORAL	2017-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204866-002	OLANZAPINE	5MG	TABLET / ORAL	2017-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204866-003	OLANZAPINE	7.5MG	TABLET / ORAL	2017-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204866-004	OLANZAPINE	10MG	TABLET / ORAL	2017-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204866-005	OLANZAPINE	15MG	TABLET / ORAL	2017-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204866-006	OLANZAPINE	20MG	TABLET / ORAL	2017-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204866-001	OLANZAPINE	2.5MG	TABLET / ORAL	2017-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204866-002	OLANZAPINE	5MG	TABLET / ORAL	2017-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204866-003	OLANZAPINE	7.5MG	TABLET / ORAL	2017-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204866-004	OLANZAPINE	10MG	TABLET / ORAL	2017-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204866-005	OLANZAPINE	15MG	TABLET / ORAL	2017-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204866-006	OLANZAPINE	20MG	TABLET / ORAL	2017-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204866-001	OLANZAPINE	2.5MG	TABLET / ORAL	2017-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204866-002	OLANZAPINE	5MG	TABLET / ORAL	2017-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204866-003	OLANZAPINE	7.5MG	TABLET / ORAL	2017-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204866-004	OLANZAPINE	10MG	TABLET / ORAL	2017-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204866-005	OLANZAPINE	15MG	TABLET / ORAL	2017-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204866-006	OLANZAPINE	20MG	TABLET / ORAL	2017-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204866-001	OLANZAPINE	2.5MG	TABLET / ORAL	2017-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204866-002	OLANZAPINE	5MG	TABLET / ORAL	2017-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204866-003	OLANZAPINE	7.5MG	TABLET / ORAL	2017-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204866-004	OLANZAPINE	10MG	TABLET / ORAL	2017-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204866-005	OLANZAPINE	15MG	TABLET / ORAL	2017-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204866-006	OLANZAPINE	20MG	TABLET / ORAL	2017-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204866-001	OLANZAPINE	2.5MG	TABLET / ORAL	2017-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204866-002	OLANZAPINE	5MG	TABLET / ORAL	2017-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204866-003	OLANZAPINE	7.5MG	TABLET / ORAL	2017-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204866-004	OLANZAPINE	10MG	TABLET / ORAL	2017-06-16	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A204866-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204866-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204866-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204866-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204866-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204866-006	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A204866-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204866-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204866-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204866-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204866-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204866-006	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204866-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204866-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204866-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204866-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204866-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204866-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204866-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204866-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204866-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204866-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204866-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204866-006	AB	1	`ea99ee380514…`

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 6 · 102 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	Cardinal Health 107, LLC	5ba67321-6988-46ea-97a0-549954e2c405	2026-07-28	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.	2a7300d3-95e3-427e-bf37-55fa654cc90a	2026-07-14	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