Application 202285

Type: ANDA
Sponsor: MYLAN

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
A202285-001	OLANZAPINE	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12
A202285-002	OLANZAPINE	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12
A202285-003	OLANZAPINE	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12
A202285-004	OLANZAPINE	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202285-001	AB
A202285-002	AB
A202285-003	AB
A202285-004	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	A202285-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202285-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202285-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202285-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202285-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202285-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202285-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202285-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202285-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202285-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202285-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202285-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202285-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202285-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202285-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202285-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202285-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202285-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202285-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202285-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202285-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202285-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202285-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202285-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202285-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202285-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202285-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202285-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202285-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202285-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202285-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202285-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202285-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202285-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202285-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202285-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202285-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202285-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202285-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202285-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-12	`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	A202285-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202285-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202285-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202285-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202285-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202285-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202285-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202285-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202285-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202285-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202285-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202285-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202285-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202285-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202285-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202285-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202285-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202285-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202285-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202285-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202285-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202285-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202285-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202285-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202285-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202285-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202285-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202285-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202285-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202285-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202285-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202285-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202285-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202285-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202285-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202285-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202285-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202285-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202285-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202285-004	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 2 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	Unit Dose Solutions, Inc.	55668be2-62ac-3252-e063-6394a90a40f7	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	e830f488-c689-40f6-9351-f9c7454ff1ea	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Redpharm Drug	54adae9e-6781-6a77-e063-6394a90ab5c8	2026-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Coupler LLC	549dc142-adcd-99ed-e063-6294a90a37fa	2026-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Coupler LLC	53e6b4e9-de26-16c3-e063-6294a90a7764	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	032e589c-47b1-4eb1-9466-8160297b81e9	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Aurobindo Pharma Limited	4d768cfe-3b20-4127-95b9-b4151b28afcc	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Coupler LLC	52b99337-afa8-a6f9-e063-6294a90a2038	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Coupler LLC	52bdaaaf-ab54-99d1-e063-6394a90a521f	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	4e90e30c-78a1-486f-a13c-f1ff798216be	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Coupler LLC	51b508ff-dc55-ff36-e063-6294a90a900f	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Coupler LLC	51b64b6d-4676-a637-e063-6394a90a450c	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Coupler LLC	518a9400-edb8-6403-e063-6294a90a065d	2026-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Golden State Medical Supply, Inc.	a1dfb4e7-4143-4422-b7a7-292e4fd75044	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
OLANZAPINE	OLANZAPINE	GLENMARK PHARMACEUTICALS INC., USA	2e709eaf-4116-4ee3-8dff-ace36181d115	2026-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OLANZAPINE generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Modavar Pharmaceuticals LLC	f0943b4e-6bdc-48c1-8ecd-39cf732e16f5	2026-04-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	XGen Pharmaceuticals DJB, Inc.	3aad0f7b-8d0c-a9bf-e063-6394a90a6ae8	2026-03-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Strides Pharma Science Limited	979c3212-36e8-4287-aace-bef0875188d7	2026-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	76a6ff21-7157-4213-8073-35837a3ac07e	2026-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine Intramuscular	OLANZAPINE	UBI Pharma Inc.	6a279fe1-ed99-4a62-b2c7-831961470fa9	2026-03-23	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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-5510	Olanzapine	olanzapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5510	Olanzapine	olanzapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5511	Olanzapine	olanzapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5511	Olanzapine	olanzapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5512	Olanzapine	olanzapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5512	Olanzapine	olanzapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5513	Olanzapine	olanzapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5513	Olanzapine	olanzapine	Mylan Pharmaceuticals Inc.	ANDA	Current
69189-5510	Olanzapine	olanzapine	Avera McKennan Hospital	ANDA	Current