Application 075876

Type: ANDA
Sponsor: MYLAN

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 43.

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	Approval date
A075876-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29
A075876-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29
A075876-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21

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 · 129 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	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`301d65b070ca…`

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	A075876-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075876-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075876-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075876-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075876-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075876-003	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 12 of 15 · 287 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acid Reducer	OMEPRAZOLE	WALGREEN CO.	b9561780-e358-b610-e053-2a95a90af020	2024-06-15	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	KROGER COMPANY	eb5d02a8-4112-2066-e053-2a95a90abba3	2024-06-15	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	8991d464-7abc-4350-e053-2995a90a4ea7	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	Aurohealth LLC	fde12bf8-3e3b-4813-a8c4-4385e7de8204	2024-06-14	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	Wal-Mart Stores, Inc.	1b4e75bf-0dcb-4fec-aca4-fc0132a79f5c	2024-06-14	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	Winco Foods, LLC.	0cb2949a-baf2-4276-a27b-8f3cc4b9a658	2024-06-14	Warnings	Name fallback generic name: OMEPRAZOLE
OMEPRAZOLE	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	3e99b78b-7fb8-4514-a3db-58e59cd429d8	2024-06-13	Warnings, Adverse reactions	Name fallback brand name: OMEPRAZOLE generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	1ab3d84c-c563-6f04-e063-6394a90a34ff	2024-06-12	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE MAGNESIUM	Safeway	7ae4d70f-08f1-4586-965f-5a32fbe21591	2024-06-04	Warnings	Name fallback brand name: omeprazole
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	e1f20429-cfaa-420b-a65a-271be37eb799	2024-05-28	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	1318a1c1-222d-471a-92d6-3632c82fb999	2024-05-24	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	18f5a7cc-40d8-4aeb-a601-47bc9024f130	2024-05-23	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
good neighbor pharmacy omeprazole	OMEPRAZOLE	Amerisource Bergen	5ee3cb79-5c0c-456f-b5d5-d5a008bbd118	2024-04-26	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Apotex Corp	b83329ac-a65e-b3af-a3fb-c5a6c740e5e7	2024-04-22	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	CHAIN DRUG MARKETING ASSOCIATION, INC.	da09aac6-8fce-448b-98ba-1fc9bce42075	2024-04-17	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	Publix Super Markets Inc	05fae639-ba68-4c05-8ca7-7c5cc2d50584	2024-04-16	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Dr. Reddy's Laboratories Limited	72fb11b6-b08c-2f02-d82b-f60f52394903	2024-04-15	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE MAGNESIUM	Walgreen Company	f56ff74d-116d-4a75-87dc-41c309f03918	2024-04-15	Warnings	Name fallback brand name: omeprazole
omeprazole	OMEPRAZOLE MAGNESIUM	Meijer, Inc.	0340ef94-d2b4-47af-a045-d0d031293984	2024-03-29	Warnings	Name fallback brand name: omeprazole
Omeprazole	OMEPRAZOLE	Kroger Company	236a9447-23ec-44c7-a241-20f9ddc83ab8	2024-03-25	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-5211	Omeprazole	omeprazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5222	Omeprazole	omeprazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6150	Omeprazole	omeprazole	Mylan Pharmaceuticals Inc.	ANDA	Current
10544-295	Omeprazole	omeprazole	Blenheim Pharmacal, Inc.	ANDA	Current
10544-299	Omeprazole	omeprazole	Blenheim Pharmacal, Inc.	ANDA	Current
35356-811	Omeprazole	Omeprazole	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
51079-007	Omeprazole	omeprazole	Mylan Institutional Inc.	ANDA	Current
52959-722	Omeprazole	Omeprazole	H.J. Harkins Company, Inc.	ANDA	Current
53808-0746	Omeprazole	omeprazole	State of Florida DOH Central Pharmacy	ANDA	Current
55154-5681	Omeprazole	omeprazole	Cardinal Health	ANDA	Current
60429-270	Omeprazole	omeprazole	Golden State Medical Supply, Inc.	ANDA	Current
60429-270	Omeprazole	omeprazole	Golden State Medical Supply, Inc.	ANDA	Current
60429-270	Omeprazole	omeprazole	Golden State Medical Supply, Inc.	ANDA	Current
60429-271	Omeprazole	omeprazole	Golden State Medical Supply, Inc.	ANDA	Current
60429-271	Omeprazole	omeprazole	Golden State Medical Supply, Inc.	ANDA	Current
63629-2607	Omeprazole	omeprazole	Bryant Ranch Prepack	ANDA	Current
63629-2607	Omeprazole	omeprazole	Bryant Ranch Prepack	ANDA	Current
66336-706	Omeprazole	omeprazole	Dispensing Solutions, Inc.	ANDA	Current