Application 202384

Type: ANDA
Sponsor: LUPIN LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OMEPRAZOLE	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	40MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202384-001	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL			2015-08-25

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 2 · 44 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
2026-10-15 13:18:30	2026-09	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202384-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2015-08-25	`3a93d1ddd44b…`

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	A202384-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A202384-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202384-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202384-001	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 14 · 280 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	Glenmark Pharmaceuticals Inc., USA	c6c22be1-659d-4e71-b292-701e27da201b	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	WinCo Foods, LLC	2782b98b-50e4-4a4e-8626-d34ebfd71bfb	2026-01-14	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Preferred Pharmaceuticals Inc.	fa0395a7-4353-4d64-9de8-d15857a7031c	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Northwind Health Company, LLC	10a3fbc9-00c6-ad83-e063-6294a90ae1ad	2026-01-05	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Northwind Health Company, LLC	f76c23d5-26b6-cfb2-e053-6294a90aea42	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Northwind Health Company, LLC	f3038133-8bb2-044e-e053-2995a90a6e7d	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Northwind Health Company, LLC	4720cc17-013e-074e-e063-6294a90ac1f4	2025-12-29	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Northwind Health Company, LLC	aae3bf9f-5d05-889f-e053-2995a90a5ff2	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Redpharm Drug	2fd1acb8-12dc-70b7-e063-6394a90a0399	2025-12-25	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Chartwell RX, LLC	10f5502a-2e63-4f2a-a3ba-ddc5bd403051	2025-12-22	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
good neighbor pharmacy omeprazole	OMEPRAZOLE	Amerisource Bergen	f9aab207-d309-49b5-b941-c2912b186583	2025-12-21	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	American Health Packaging	205652e1-7fbc-4b6a-bbd6-2fd346d812df	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	Kroger Company	015b1c8f-9d5b-4afc-a55c-1a731b5fc72a	2025-12-08	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	QPharma, Inc.	f5dd5d63-1376-1ff7-e053-2a95a90a1d94	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Redpharm Drug	44f59d88-d401-950b-e063-6294a90a2a50	2025-12-02	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	17ccdbe0-19c1-498d-8e81-578be549b4e5	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	QPharma, Inc.	f5dcf0b2-4fa2-023a-e053-2995a90a183a	2025-12-01	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Quallent Pharmaceuticals Health LLC	665e9877-85ac-fdb6-54ac-1c47941ceab8	2025-11-28	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	43090803-37de-77e3-e063-6294a90a8c43	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Family Dollar (FAMILY WELLNESS)	f2195d73-1fd5-4de2-aa5c-18741d11f4fc	2025-10-30	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.