Application 075785

Type: ANDA
Sponsor: IMPAX LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OMEPRAZOLE	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	10MG	No	No
002	OMEPRAZOLE	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	20MG	No	No
003	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075785-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22
A075785-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22
A075785-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A075785-001	AB
A075785-002	AB
A075785-003	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 4 · 132 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	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075785-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075785-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075785-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A075785-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075785-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075785-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075785-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075785-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075785-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075785-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075785-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075785-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075785-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075785-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075785-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075785-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075785-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075785-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075785-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075785-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075785-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075785-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075785-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075785-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075785-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075785-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075785-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075785-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075785-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075785-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075785-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075785-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075785-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075785-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075785-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075785-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075785-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075785-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075785-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075785-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075785-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075785-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075785-001	AB	1	`79d66fd596c7…`

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 13 of 14 · 280 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
foster and thrive omeprazole	OMEPRAZOLE	Strategic Sourcing Services LLC	836efc63-b633-497c-ab56-76bb495bd723	2024-02-20	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Aurohealth LLC	19097902-a5e6-423a-8569-31c569cd3cdb	2024-02-19	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	a656a059-2b1a-44b3-85f8-af278032b54c	2024-01-04	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	a52842ac-ac9d-4344-9823-b8b2afb07903	2023-12-14	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	VALU MERCHANDISERS COMPANY	7b2d41b6-3e36-4973-b5f6-adf9b828f40d	2023-12-13	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	DISCOUNT DRUG MART	ff2c8446-9d8b-4300-b157-884b48e98bb7	2023-12-02	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	Best Choice	43ea758b-6cea-44a2-b4d6-8f99211c8826	2023-12-02	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	RELIABLE 1 LABORATORIES LLC	f6b13640-6c71-4c3d-8eb5-c36fca201aee	2023-12-02	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	7-Eleven	61206416-e0c1-44d7-ad35-feb629361ba9	2023-12-02	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	8f13fd38-dc73-4072-bdc9-9474704a4121	2023-11-22	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole/Sodium Bicarbonate	OMEPRAZOLE	Strides Pharma Science Limited	cf6d293e-d70d-443e-8292-d693e93aab55	2023-09-21	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	b129fe93-c8a2-4ae8-ad1b-8f9ae5779b68	2023-09-10	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
equaline omeprazole	OMEPRAZOLE	United Natural Foods, Inc. dba UNFI	78743f3b-257e-49df-98cd-6cc0e1b4e370	2023-08-16	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	STRATEGIC SOURCING SERVICES LLC	56380ccc-6fc2-4e1b-bd87-da24c9aa31cd	2023-08-14	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
equaline omeprazole	OMEPRAZOLE	United Natural Foods, Inc. dba UNFI	b6c87a6a-253a-4455-9b7d-62f506da592e	2023-08-02	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Proficient Rx LP	13b379ef-7982-434d-9e6b-e01cd2b398d2	2023-08-01	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	39e3b45a-8e9b-49d6-976a-6668f4e27649	2023-07-10	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	NorthStar Rx LLC	c5af5f4b-17be-7245-b281-f27c87831242	2023-06-20	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Zydus Pharmaceuticals USA Inc.	9c22ceb2-2c34-43c3-9a35-2589c9078741	2023-05-11	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Sandoz Inc	e4562da8-9d94-4417-9f80-c1ffd4247259	2023-04-30	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE

Reported adverse events (FAERS/openFDA)#

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