Application 076000

Type: ANDA
Sponsor: TEVA 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

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076000-001	OLANZAPINE	OLANZAPINE	2.5MG	TABLET / ORAL	2011-10-24
A076000-002	OLANZAPINE	OLANZAPINE	5MG	TABLET / ORAL	2011-10-24
A076000-003	OLANZAPINE	OLANZAPINE	7.5MG	TABLET / ORAL	2011-10-24
A076000-004	OLANZAPINE	OLANZAPINE	10MG	TABLET / ORAL	2011-10-24
A076000-005	OLANZAPINE	OLANZAPINE	15MG	TABLET / ORAL	2011-10-24

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 6 · 215 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	A076000-001	OLANZAPINE	2.5MG	TABLET / ORAL	2011-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076000-002	OLANZAPINE	5MG	TABLET / ORAL	2011-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076000-003	OLANZAPINE	7.5MG	TABLET / ORAL	2011-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076000-004	OLANZAPINE	10MG	TABLET / ORAL	2011-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076000-005	OLANZAPINE	15MG	TABLET / ORAL	2011-10-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076000-001	OLANZAPINE	2.5MG	TABLET / ORAL	2011-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076000-002	OLANZAPINE	5MG	TABLET / ORAL	2011-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076000-003	OLANZAPINE	7.5MG	TABLET / ORAL	2011-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076000-004	OLANZAPINE	10MG	TABLET / ORAL	2011-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076000-005	OLANZAPINE	15MG	TABLET / ORAL	2011-10-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076000-001	OLANZAPINE	2.5MG	TABLET / ORAL	2011-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076000-002	OLANZAPINE	5MG	TABLET / ORAL	2011-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076000-003	OLANZAPINE	7.5MG	TABLET / ORAL	2011-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076000-004	OLANZAPINE	10MG	TABLET / ORAL	2011-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076000-005	OLANZAPINE	15MG	TABLET / ORAL	2011-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076000-001	OLANZAPINE	2.5MG	TABLET / ORAL	2011-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076000-002	OLANZAPINE	5MG	TABLET / ORAL	2011-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076000-003	OLANZAPINE	7.5MG	TABLET / ORAL	2011-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076000-004	OLANZAPINE	10MG	TABLET / ORAL	2011-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076000-005	OLANZAPINE	15MG	TABLET / ORAL	2011-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076000-001	OLANZAPINE	2.5MG	TABLET / ORAL	2011-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076000-002	OLANZAPINE	5MG	TABLET / ORAL	2011-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076000-003	OLANZAPINE	7.5MG	TABLET / ORAL	2011-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076000-004	OLANZAPINE	10MG	TABLET / ORAL	2011-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076000-005	OLANZAPINE	15MG	TABLET / ORAL	2011-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076000-001	OLANZAPINE	2.5MG	TABLET / ORAL	2011-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076000-002	OLANZAPINE	5MG	TABLET / ORAL	2011-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076000-003	OLANZAPINE	7.5MG	TABLET / ORAL	2011-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076000-004	OLANZAPINE	10MG	TABLET / ORAL	2011-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076000-005	OLANZAPINE	15MG	TABLET / ORAL	2011-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076000-001	OLANZAPINE	2.5MG	TABLET / ORAL	2011-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076000-002	OLANZAPINE	5MG	TABLET / ORAL	2011-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076000-003	OLANZAPINE	7.5MG	TABLET / ORAL	2011-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076000-004	OLANZAPINE	10MG	TABLET / ORAL	2011-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076000-005	OLANZAPINE	15MG	TABLET / ORAL	2011-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076000-001	OLANZAPINE	2.5MG	TABLET / ORAL	2011-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076000-002	OLANZAPINE	5MG	TABLET / ORAL	2011-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076000-003	OLANZAPINE	7.5MG	TABLET / ORAL	2011-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076000-004	OLANZAPINE	10MG	TABLET / ORAL	2011-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076000-005	OLANZAPINE	15MG	TABLET / ORAL	2011-10-24	`03ed91905a0d…`

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	A076000-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076000-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076000-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076000-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076000-005	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076000-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076000-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076000-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076000-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076000-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076000-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076000-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076000-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076000-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076000-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076000-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076000-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076000-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076000-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076000-005	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 4 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	Qilu Pharmaceutical Co., Ltd.	12ce860a-6f22-4db6-8acf-786b40f5a5a5	2025-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	American Health Packaging	75616c31-8fed-4014-a9f2-4a028eccd586	2025-10-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Coupler LLC	40187874-447a-de20-e063-6394a90aafe7	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Coupler LLC	3ed78a7d-4014-d280-e063-6294a90a8ee9	2025-09-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Preferred Pharmaceuticals Inc.	cfc0f187-d3ff-4bbb-9129-0e94c6eda0ee	2025-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine Intramuscular	OLANZAPINE	PAI Holdings, LLC dba PAI Pharma	9d9f25d5-4513-434a-a37a-392a0c978f2e	2025-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Coupler LLC	37c88965-c51d-946d-e063-6394a90a012c	2025-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	1866a03c-eac9-44a1-8f33-7dc6e8a8c06a	2025-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	3c9963b1-c498-48a0-a3a1-1eaa6a1028fc	2025-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	f6fd7ceb-1457-4c3e-9d30-4f658f39d37d	2025-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	c47f90fc-49fe-4f60-9da8-1365a1650dd9	2025-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	dcf8fcbf-636c-41ad-8084-c65ac2f117cc	2025-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	8586e828-34e7-4eb4-a933-6c688927478f	2025-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	d5a9f78e-56f4-4249-800c-5f52a99fa84b	2025-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	d3857220-d9ff-4820-bf53-f2384b59a1a6	2025-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	ed93d6b9-912a-444a-a695-439d0bfb877a	2025-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Golden State Medical Supply, Inc.	9847a0e4-24fc-f4e8-e053-2995a90a961e	2025-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Coupler LLC	325d5d69-5133-79ea-e063-6294a90afdd0	2025-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Jubilant Cadista Pharmacuticals Inc.	028aa88e-fa50-7aa8-cc0b-97c0c9a0357c	2025-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Cadila Pharmaceuticals Limited	2ae07ad4-4e58-4740-9f02-035ec061fefc	2025-03-11	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 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-5767	Olanzapine	Olanzapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5767	Olanzapine	Olanzapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5768	Olanzapine	Olanzapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5768	Olanzapine	Olanzapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5769	Olanzapine	Olanzapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5769	Olanzapine	Olanzapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5770	Olanzapine	Olanzapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5770	Olanzapine	Olanzapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5771	Olanzapine	Olanzapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5771	Olanzapine	Olanzapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0615-7670	Olanzapine	Olanzapine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7671	olanzapine	olanzapine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7672	olanzapine	olanzapine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7699	Olanzapine	Olanzapine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
42254-203	Olanzapine	Olanzapine	Rebel Distributors Corp	ANDA	Current
42254-204	Olanzapine	Olanzapine	Rebel Distributors Corp	ANDA	Current
42254-205	Olanzapine	Olanzapine	Rebel Distributors Corp	ANDA	Current
42254-222	Olanzapine	Olanzapine	Rebel Distributors Corp	ANDA	Current
49349-931	Olanzapine	OLANZAPINE	REMEDYREPACK INC.	ANDA	Current
50090-2693	Olanzapine	Olanzapine	A-S Medication Solutions	ANDA	Current
50090-2846	Olanzapine	Olanzapine	A-S Medication Solutions	ANDA	Current
64725-5768	Olanzapine	Olanzapine	TYA Pharmaceuticals	ANDA	Current
68258-7095	Olanzapine	Olanzapine	Dispensing Solutions, Inc.	ANDA	Current
68258-7096	Olanzapine	Olanzapine	Dispensing Solutions, Inc.	ANDA	Current
68258-7152	Olanzapine	Olanzapine	Dispensing Solutions, Inc.	ANDA	Current
68258-7153	Olanzapine	Olanzapine	Dispensing Solutions, Inc.	ANDA	Current
68258-7154	Olanzapine	Olanzapine	Dispensing Solutions, Inc.	ANDA	Current
70518-0433	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-0477	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-0477	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current