Application 076255

Type: ANDA
Sponsor: DR REDDYS LABS LTD

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A076255-001	OLANZAPINE	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23
A076255-002	OLANZAPINE	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23
A076255-003	OLANZAPINE	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23
A076255-004	OLANZAPINE	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076255-001	AB
A076255-002	AB
A076255-003	AB
A076255-004	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 · 164 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
2026-02-19 14:30 UTC	2026-02	A076255-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076255-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076255-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076255-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076255-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076255-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076255-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076255-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076255-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076255-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076255-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076255-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076255-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076255-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076255-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076255-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076255-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076255-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076255-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076255-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076255-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076255-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076255-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076255-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076255-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076255-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076255-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076255-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076255-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076255-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076255-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076255-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076255-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076255-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076255-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076255-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076255-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076255-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076255-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076255-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076255-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076255-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076255-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076255-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076255-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076255-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076255-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076255-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076255-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076255-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076255-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076255-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076255-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076255-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076255-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076255-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076255-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076255-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076255-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076255-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076255-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076255-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076255-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076255-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076255-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076255-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076255-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076255-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076255-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076255-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076255-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076255-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076255-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076255-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076255-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076255-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076255-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076255-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076255-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076255-004	AB	1	`d06236e962d9…`

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 1 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	2a7300d3-95e3-427e-bf37-55fa654cc90a	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255 ndc (product): 70518-1635
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	3d69af75-7615-4ec2-b7ef-467b2558c5c8	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255 ndc (product): 70518-1764
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	b513823d-927c-4111-8766-e6c37f84b221	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255 ndc (product): 70518-1605
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	68de2a51-69b2-4d99-be79-36a95a4bc475	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255 ndc (product): 70518-1611
Olanzapine	OLANZAPINE	Major Pharmaceuticals	0ecbf540-572e-4ca4-b694-18ca1cd1c194	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	Unit Dose Solutions, Inc.	55669a10-93f3-cfd6-e063-6294a90aa0e6	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	Unit Dose Solutions, Inc.	55668be2-62ac-3252-e063-6394a90a40f7	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	Coupler LLC	53e6b4e9-de26-16c3-e063-6294a90a7764	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	Coupler LLC	52b99337-afa8-a6f9-e063-6294a90a2038	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	Coupler LLC	51b64b6d-4676-a637-e063-6394a90a450c	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	Dr. Reddy's Laboratories Inc.	d474d5a9-d338-511d-5823-567c0a1bbf4d	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	Cardinal Health 107, LLC	38a89689-efc2-4931-8f65-868dc0248d6a	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	dc56c264-d10e-4059-b0d5-2feff16b345d	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	American Health Packaging	75616c31-8fed-4014-a9f2-4a028eccd586	2025-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	Preferred Pharmaceuticals Inc.	cfc0f187-d3ff-4bbb-9129-0e94c6eda0ee	2025-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	Preferred Pharmaceuticals Inc.	d349d5b7-5658-46d6-9bba-e6f6361cebb9	2025-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	PD-Rx Pharmaceuticals, Inc.	10043041-a632-4e57-bc08-37216dea8546	2025-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	3c9963b1-c498-48a0-a3a1-1eaa6a1028fc	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	09e48e71-4dd2-4538-91d7-5b284f6647d8	2023-03-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255 ndc (product): 71335-0714
Olanzapine	OLANZAPINE	Dr. Reddy's Laboratories Ltd.	9a57a63e-f856-aafa-037a-c08f2fea6496	2022-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076255 application number: ANDA076255

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 107 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-1605	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1605	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1605	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1605	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1605	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1611	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1611	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1611	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1611	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1611	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1611	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1611	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1611	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1635	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1635	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1635	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1635	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1635	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1635	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1764	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1764	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1764	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1764	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
71335-0714	Olanzapine	Olanzapine	Bryant Ranch Prepack	ANDA	Current
71335-0714	Olanzapine	Olanzapine	Bryant Ranch Prepack	ANDA	Current
71335-0714	Olanzapine	Olanzapine	Bryant Ranch Prepack	ANDA	Current
71335-0714	Olanzapine	Olanzapine	Bryant Ranch Prepack	ANDA	Current