Application 090459

Type: ANDA
Sponsor: ZYDUS 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	TE codes	Approval date
A090459-001	OLANZAPINE	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2018-07-16
A090459-002	OLANZAPINE	OLANZAPINE	5MG	TABLET / ORAL	AB	2018-07-16
A090459-003	OLANZAPINE	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2018-07-16
A090459-004	OLANZAPINE	OLANZAPINE	10MG	TABLET / ORAL	AB	2018-07-16
A090459-005	OLANZAPINE	OLANZAPINE	15MG	TABLET / ORAL	AB	2018-07-16
A090459-006	OLANZAPINE	OLANZAPINE	20MG	TABLET / ORAL	AB	2018-07-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090459-001	AB
A090459-002	AB
A090459-003	AB
A090459-004	AB
A090459-005	AB
A090459-006	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 1 of 7 · 258 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	A090459-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2018-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090459-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2018-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090459-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2018-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090459-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2018-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090459-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2018-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090459-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2018-07-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090459-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090459-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090459-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090459-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090459-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090459-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2018-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090459-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2018-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090459-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2018-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090459-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2018-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090459-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2018-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090459-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2018-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090459-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2018-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090459-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2018-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090459-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2018-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090459-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2018-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090459-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2018-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090459-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2018-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090459-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2018-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090459-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2018-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090459-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2018-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090459-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2018-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090459-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2018-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090459-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2018-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090459-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2018-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090459-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2018-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090459-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2018-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090459-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2018-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090459-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2018-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090459-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2018-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090459-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2018-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090459-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2018-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090459-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2018-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090459-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2018-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090459-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2018-07-16	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 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	A090459-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090459-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090459-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090459-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090459-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090459-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090459-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090459-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090459-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090459-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090459-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090459-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090459-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090459-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090459-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090459-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090459-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090459-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090459-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090459-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090459-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090459-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090459-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090459-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090459-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090459-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090459-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090459-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090459-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090459-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090459-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090459-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090459-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090459-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090459-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090459-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090459-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090459-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090459-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090459-004	AB	1	`b8a1b40f171c…`

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 5 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	Direct_Rx	fcec190f-b865-c5d3-e053-6394a90a7e45	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Direct_Rx	22528ae1-e36f-48e1-e063-6294a90a3dd2	2024-09-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	NorthStar RxLLC	ea3259d5-36ee-4ac9-b849-9625626e2187	2024-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Qilu Pharmaceutical Co., Ltd.	6077f5c4-01d7-4c1d-97a0-cb859f98ce68	2024-06-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Proficient Rx LP	024e8e9b-a4fc-4882-b080-c070467166a6	2024-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	NorthStar RxLLC	f4e41c2c-d32d-40c2-8afb-b6df998ba6b0	2023-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Lannett Company, Inc.	002dd00f-7946-ea4f-e063-6294a90a5916	2023-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	09e48e71-4dd2-4538-91d7-5b284f6647d8	2023-03-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Proficient Rx LP	ce66d545-015b-41d5-80c3-964d78e36bfd	2023-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Dr. Reddy's Laboratories Ltd.	9a57a63e-f856-aafa-037a-c08f2fea6496	2022-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Proficient Rx LP	1f4a2eaf-3a12-4ebe-b97f-0a7bfbc32572	2022-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Proficient Rx LP	e40d54bf-7334-4418-8a87-ff85941adec1	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Proficient Rx LP	61424fa3-b09a-4267-a208-a7c7c3f69fe5	2020-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Aphena Pharma Solutions - Tennessee, LLC	b6ec5610-b4a6-4646-954a-0fe8b1d3e143	2020-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Proficient Rx LP	7772a4c2-1fb1-412b-9e3b-ef3d693517a2	2019-11-01	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-364	olanzapine	olanzapine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-364	olanzapine	olanzapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-364	olanzapine	olanzapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-365	olanzapine	olanzapine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-365	olanzapine	olanzapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-365	olanzapine	olanzapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-366	olanzapine	olanzapine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-366	olanzapine	olanzapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-366	olanzapine	olanzapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-367	olanzapine	olanzapine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-367	olanzapine	olanzapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-367	olanzapine	olanzapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-368	olanzapine	olanzapine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-368	olanzapine	olanzapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-368	olanzapine	olanzapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-369	olanzapine	olanzapine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-369	olanzapine	olanzapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-369	olanzapine	olanzapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1416	olanzapine	olanzapine	Zydus Lifesciences Limited	ANDA	Current
70771-1416	olanzapine	olanzapine	Cadila Healthcare Limited	ANDA	Current
70771-1416	olanzapine	olanzapine	Cadila Healthcare Limited	ANDA	Current
70771-1416	olanzapine	olanzapine	Cadila Healthcare Limited	ANDA	Current
70771-1417	olanzapine	olanzapine	Zydus Lifesciences Limited	ANDA	Current
70771-1417	olanzapine	olanzapine	Cadila Healthcare Limited	ANDA	Current
70771-1417	olanzapine	olanzapine	Cadila Healthcare Limited	ANDA	Current
70771-1417	olanzapine	olanzapine	Cadila Healthcare Limited	ANDA	Current
70771-1418	olanzapine	olanzapine	Zydus Lifesciences Limited	ANDA	Current
70771-1418	olanzapine	olanzapine	Cadila Healthcare Limited	ANDA	Current
70771-1418	olanzapine	olanzapine	Cadila Healthcare Limited	ANDA	Current
70771-1418	olanzapine	olanzapine	Cadila Healthcare Limited	ANDA	Current
70771-1419	olanzapine	olanzapine	Zydus Lifesciences Limited	ANDA	Current
70771-1419	olanzapine	olanzapine	Cadila Healthcare Limited	ANDA	Current
70771-1419	olanzapine	olanzapine	Cadila Healthcare Limited	ANDA	Current
70771-1419	olanzapine	olanzapine	Cadila Healthcare Limited	ANDA	Current
70771-1420	olanzapine	olanzapine	Zydus Lifesciences Limited	ANDA	Current
70771-1420	olanzapine	olanzapine	Cadila Healthcare Limited	ANDA	Current
70771-1420	olanzapine	olanzapine	Cadila Healthcare Limited	ANDA	Current
70771-1420	olanzapine	olanzapine	Cadila Healthcare Limited	ANDA	Current
70771-1421	olanzapine	olanzapine	Zydus Lifesciences Limited	ANDA	Current
70771-1421	olanzapine	olanzapine	Cadila Healthcare Limited	ANDA	Current
70771-1421	olanzapine	olanzapine	Cadila Healthcare Limited	ANDA	Current
70771-1421	olanzapine	olanzapine	Cadila Healthcare Limited	ANDA	Current