Application 091038

Type: ANDA
Sponsor: SUN PHARM INDS

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
A091038-001	OLANZAPINE	OLANZAPINE	2.5MG	TABLET / ORAL	2012-04-23
A091038-002	OLANZAPINE	OLANZAPINE	5MG	TABLET / ORAL	2012-04-23
A091038-003	OLANZAPINE	OLANZAPINE	7.5MG	TABLET / ORAL	2012-04-23
A091038-004	OLANZAPINE	OLANZAPINE	10MG	TABLET / ORAL	2012-04-23
A091038-005	OLANZAPINE	OLANZAPINE	15MG	TABLET / ORAL	2012-04-23
A091038-006	OLANZAPINE	OLANZAPINE	20MG	TABLET / ORAL	2012-04-23

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	A091038-001	OLANZAPINE	2.5MG	TABLET / ORAL	2012-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091038-002	OLANZAPINE	5MG	TABLET / ORAL	2012-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091038-003	OLANZAPINE	7.5MG	TABLET / ORAL	2012-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091038-004	OLANZAPINE	10MG	TABLET / ORAL	2012-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091038-005	OLANZAPINE	15MG	TABLET / ORAL	2012-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091038-006	OLANZAPINE	20MG	TABLET / ORAL	2012-04-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091038-001	OLANZAPINE	2.5MG	TABLET / ORAL	2012-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091038-002	OLANZAPINE	5MG	TABLET / ORAL	2012-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091038-003	OLANZAPINE	7.5MG	TABLET / ORAL	2012-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091038-004	OLANZAPINE	10MG	TABLET / ORAL	2012-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091038-005	OLANZAPINE	15MG	TABLET / ORAL	2012-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091038-006	OLANZAPINE	20MG	TABLET / ORAL	2012-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091038-001	OLANZAPINE	2.5MG	TABLET / ORAL	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091038-002	OLANZAPINE	5MG	TABLET / ORAL	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091038-003	OLANZAPINE	7.5MG	TABLET / ORAL	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091038-004	OLANZAPINE	10MG	TABLET / ORAL	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091038-005	OLANZAPINE	15MG	TABLET / ORAL	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091038-006	OLANZAPINE	20MG	TABLET / ORAL	2012-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091038-001	OLANZAPINE	2.5MG	TABLET / ORAL	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091038-002	OLANZAPINE	5MG	TABLET / ORAL	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091038-003	OLANZAPINE	7.5MG	TABLET / ORAL	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091038-004	OLANZAPINE	10MG	TABLET / ORAL	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091038-005	OLANZAPINE	15MG	TABLET / ORAL	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091038-006	OLANZAPINE	20MG	TABLET / ORAL	2012-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091038-001	OLANZAPINE	2.5MG	TABLET / ORAL	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091038-002	OLANZAPINE	5MG	TABLET / ORAL	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091038-003	OLANZAPINE	7.5MG	TABLET / ORAL	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091038-004	OLANZAPINE	10MG	TABLET / ORAL	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091038-005	OLANZAPINE	15MG	TABLET / ORAL	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091038-006	OLANZAPINE	20MG	TABLET / ORAL	2012-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091038-001	OLANZAPINE	2.5MG	TABLET / ORAL	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091038-002	OLANZAPINE	5MG	TABLET / ORAL	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091038-003	OLANZAPINE	7.5MG	TABLET / ORAL	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091038-004	OLANZAPINE	10MG	TABLET / ORAL	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091038-005	OLANZAPINE	15MG	TABLET / ORAL	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091038-006	OLANZAPINE	20MG	TABLET / ORAL	2012-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091038-001	OLANZAPINE	2.5MG	TABLET / ORAL	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091038-002	OLANZAPINE	5MG	TABLET / ORAL	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091038-003	OLANZAPINE	7.5MG	TABLET / ORAL	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091038-004	OLANZAPINE	10MG	TABLET / ORAL	2012-04-23	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 162 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A091038-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091038-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091038-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091038-004	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091038-005	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091038-006	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091038-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091038-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091038-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091038-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091038-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091038-006	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091038-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091038-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091038-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091038-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091038-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091038-006	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091038-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091038-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091038-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091038-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091038-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091038-006	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091038-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091038-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091038-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091038-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091038-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091038-006	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091038-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091038-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091038-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091038-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091038-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091038-006	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091038-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091038-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091038-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091038-004	AB	1	`782e0a99824c…`

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 3 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	HEC Pharm USA Inc.	4d1b83db-54db-d51f-e063-6394a90a4a69	2026-03-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
OLANZAPINE	OLANZAPINE	HEC Pharm USA Inc.	4d34f8f3-edc8-0a68-e063-6394a90a9c1f	2026-03-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OLANZAPINE generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Dr.Reddy's Laboratories Limited	aff02cff-d079-bc82-6182-a24c4c6e09a6	2026-03-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Dr. Reddy's Laboratories Inc.	d474d5a9-d338-511d-5823-567c0a1bbf4d	2026-03-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
OLANZAPINE	OLANZAPINE	Anthea Pharma Private Limited	e6ffcc56-63f9-4b12-a07a-c6177ffef5e8	2026-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OLANZAPINE generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Macleods Pharmaceuticals Limited	8e095987-bdea-42f2-9550-c7155cf07d30	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Macleods Pharmaceuticals Limited	df43938a-3469-40eb-8166-f0a2fd29d6d8	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
OLANZAPINE	OLANZAPINE	Torrent Pharmaceuticals Limited	2cb1bebe-0ced-46d8-bf21-c28a9acc4a15	2026-03-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OLANZAPINE generic name: OLANZAPINE
Olanzapine	OLANZAPINE	American Regent, Inc.	e9ac2bd3-dbff-4b1a-952f-da3909c6e4ee	2026-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Teva Pharmaceuticals USA, Inc.	dd0b2525-4e2f-44fc-9302-0ae4ebb1e135	2026-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Sandoz Inc	c44a96cc-817d-4eb5-a13a-00977f76e666	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	American Health Packaging	c0d705bf-b719-4c7b-b83d-c17d41cbbfad	2026-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Sandoz Inc	1e9666ef-4271-4834-8496-ccb3125d83db	2026-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
OLANZAPINE	OLANZAPINE	Eugia US LLC	9c745e2e-89d3-44d4-906e-704705c33310	2026-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OLANZAPINE generic name: OLANZAPINE
Zyprexa	OLANZAPINE	H2-Pharma LLC	b418946a-1ab4-4d89-a012-d94fc361a3c4	2026-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Aurobindo Pharma Limited	636665be-9d7e-443a-8134-e8cc47e6ba24	2026-02-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Coupler LLC	495efc49-7cdb-4b9e-e063-6394a90a547e	2026-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Ascend Laboratories, LLC	e8626e68-088d-47ff-bf06-489a778815aa	2025-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Apotex Corp.	3347d1c8-04c9-5ce1-8cda-b38e0412b709	2025-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Coupler LLC	42d9ad47-52cc-ad11-e063-6394a90aedca	2025-11-05	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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64725-0552	Olanzapine	Olanzapine	TYA Pharmaceuticals	ANDA	Current
64725-0554	Olanzapine	Olanzapine	TYA Pharmaceuticals	ANDA	Current
64725-0555	Olanzapine	Olanzapine	TYA Pharmaceuticals	ANDA	Current
70518-0026	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current